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aMAZE - Left Atrial Appendage Ligation with the LARIAT+®Suture Delivery Systemas Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation

The left atrial appendage (LAA) is a small sac about the size of your thumb that hangs off the left atrium. It may add to the abnormal heart rhythm of atrial fibrillation (AF). This study is looking at using a newer non-surgical procedure to close the LAA combined with catheter ablation for AF. By closing the LAA, it is hoped that this may treat AF more effectively as compared to catheter ablation alone. This study involves a device called the LARIAT+ Suture Delivery System (or “LARIAT”) to close the LAA. The purpose of this study is to evaluate the safety and effectiveness of the LARIAT in subjects with Persistent and Longstanding Persistent AF.

AWARE - Impact of anxiety on cardiac substrate modification in woman with atrial fibrillation undergoing catheter ablation

Research studies have suggested an association between anxiety disorders and increased risk of AF. This risk is believed to be attributed to chronic inflammation resulting from anxiety which may cause changes in the heart tissue. These inflammatory changes in the heart tissue may initiate non-PV triggers and scar formation in the left atrium (LA – left upper chamber of the heart). Non-PV triggers and LA scar are known risk factors for recurrence of AF after ablation.

The purpose of this study is to evaluate the impact of anxiety on the heart tissue changes leading to non-PV triggers and LA scar in patients after AF ablation.

COGNITION - Mild cognitive impairment (MCI) in patients with atrial fibrillation (AF), trajectories of the progression of MCI and factors associated with the progression

The purpose of this study is to evaluate the incidence of cognitive impairment in AF and compare two treatment strategies: anti-arrhythmic drugs (AADs) and ablation. Questionnaires will be used to evaluate your cognitive status.

CONNECT HF - Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

The primary objective of this trial is to assess the effect of a quality improvement program and digital technology compared with usual care on heart failure. Patients admitted to the hospital for acute heart failure and reduced left ventricular ejection fraction (LVEF) are enrolled and followed for 1 year.

This study is currently in follow-up only and is not enrolling new patients.

CVRx Barostim Neo® – Baroreflex Activation Therapy® for Heart Failure

The purpose of this research study is to show whether the Barotim Neo device is safe and works in people with heart failure. The Neo system is a device that is designed to stimulate the body’s natural cardiovascular regulators called baroreceptors, which are in the large blood vessels (carotid arteries) in your neck and potentially improve your heart failure condition. It is believed that when the baroreceptors are stimulated, signals are sent to the brain. The brain then sends signals to the body telling the blood vessels to relax, the heart to slow the heartbeat and stop production of stress-related hormones in the heart, and the kidneys to reduce the amount of fluid in the body.

This study is currently in follow-up only and is not enrolling new patients.

DIAMOND AF II - A Prospective Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Persistent Atrial Fibrillation

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation procedure. The purpose of this clinical study is to see whether the DiamondTemp Ablation catheter System (DiamondTemp) can restore your heart to a normal heart rhythm. DiamondTemp has new technology (network of diamonds in the catheter tip) that allows the tip to be cooled more efficiently. The cooling technology allows for accurate measurement of the heart tissue surface temperature to maintain safe but effective temperatures during ablation. This study will enroll 300 subjects at up to 30 hospitals in the US, Canada, and Europe. Participation will last 12 months.

This study is currently in follow-up only and is not enrolling new patients.

ECG Belt for CRT Response

This study will evaluate the Medtronic ECG Belt Research System for patients who are planning to have a cardiac resynchronization therapy (CRT) device implanted. The purpose of this study is to compare the management of CRTpatients using the ECG Belt and using routine medical care. The ECG Belt includes an electrode array which wraps around your chest and back and has electrodes on each side. The ECG Belt is temporarily attached to your body for the duration of the visit, and then removed once study testing is complete. About 455 subjects will be in this study in the United States, Canada, and Europe. Participation may last for approximately 9 months.

Half-Normal Saline vs Normal Saline For Irrigation of Open-Irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation

This study will evaluate the safety and effectiveness of two irrigation solutions: the standard normal saline (9 grams per liter of sodium chloride) and half-normal saline (4.5 grams per liter of sodium chloride). During an ablation, your doctor will use an ablation catheter which is irrigated with a saline solution (salt water) to produce a more effective lesion. Usually, ‘normal’ saline is used, which has a salt concentration similar to tears, blood, and other body fluids. Animal studies and infrequent use in humans suggest that using a lower concentration of salt in the irrigation solution may improve the effectiveness of ablation by producing deeper and larger lesions. There are no investigational properties used in this study. All equipment is approved by the FDA

Half-Normal Saline vs Normal Saline for Irrigation of Open-Irrigated Radiofrequency Catheters in Left Ventricular Outflow Tract Arrhythmias Ablation

This study will evaluate the safety and effectiveness of two irrigation solutions: the standard normal saline (9 grams per liter of sodium chloride) and half-normal saline (4.5 grams per liter of sodium chloride). Tachycardia (VT). During this procedure, your doctor will use an ablation catheter which is irrigated with a saline solution (salt water) to produce a more effective lesion. Usually, ‘normal’ saline is used, which has a salt concentration similar to tears, blood, and other body fluids. Animal studies and infrequent use in humans suggest that using a lower concentration of salt in the irrigation solution may improve the effectiveness of ablation by producing deeper and larger lesions. There are no investigational properties used in this study. All equipment is approved by the FDA.

LESS VT - FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT

The purpose of this study is to show that the FlexAbility™ SE Ablation Catheter (FlexAbility™) is safe and effective in reducing the number of ventricular tachycardia (VT) episodes in patients who continue to experience VT despite taking antiarrhythmic medications, or who are unable to take antiarrhythmic medications. The FlexAbility™ SE Ablation Catheter is approved in the United States to treat irregular heartbeats in the atria (upper chambers of the heart) and is being used in this study to treat irregular heartbeats in the ventricles (lower chambers of the heart).

Involvement will last for 1 year and up to 592 people will participate at up to 35 sites worldwide.

Lifestyle AF - Impact of Lifestyle Modification On Ablation Outcome in Atrial Fibrillation

The purpose of this research study is to evaluate the impact of aggressive lifestyle modification on the outcome of atrial fibrillation (AF) ablation in overweight and obese patients with AF by using diet and exercise. It will enroll patients that have chronic (long term) AF, and are scheduled to undergo an ablation procedure to treat the AF. You will undergo different levels of diet consultation and exercise to determine their effect on the outcome of the ablation procedure.

MAGNETIC-VT - comparing VT ablation outcomes using remote MAGNETIC navigation guided substrate mapping and ablation versus manual approach in a low LVEF population

This prospective, multi-center, post market randomized trial will compare the outcomes of Ventricular Tachycardia (VT) ablation using standard manual placement of the catheter versus magnetic placement of the catheter using the Niobe™ ES MAGNETIC catheter system. This system allows the doctor to remotely maneuver the catheter, rather than move it manually.

The study will enroll patients who are scheduled to undergo an ablation procedure to treat VT and have an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) who have also experiences a myocardial infarction (MI) or ‘heart attach’ that resulted in scar tissue.

All ablation equipment used in this study is approved by the United States Food and Drug Administration (FDA).

Medtronic ADAPT Response Study

CRT device feature called AdaptivCRT (aCRT) will be evaluated in this study. It is designed to automatically optimize CRT pacing therapy by observing patterns in your heart’s contractions and then automatically adjusting your CRT device settings. Currently, an echocardiogram (ultrasound of the heart) or an ECG (records the electrical tracing of the heart’s activity) may be used to provide information needed to program CRT devices. Another option is to use the standard factory settings. This study will investigate the benefits of the aCRT feature compared to these other methods. The aCRT feature is used in addition to standard CRT therapy.

This study is currently in follow-up only and is not enrolling new patients.

Medtronic Product Surveillance Registry

The primary purpose of this prospective, non-randomized, multi-center study is to evaluate and publish the long-term reliability and performance of Medtronic market-released cardiac therapy products by analyzing product survival probabilities. Product-related adverse events, indicating the status of the product, will be collected to measure survival probabilities. The data gathered in this study may also be used to support the design and development of investigational plans for new cardiac therapy products.

Option - Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

The purpose of this study is to determine if LAA closure with the WATCHMAN FLX Device is a reasonable alternative to OAC following AF ablation. The WATCHMAN FLX™ LAAC Device is intended to prevent clots that originate from the LAA from dislodging and leading to potential stroke. This device is investigational, which means it has not been approved by the FDA and is being evaluated in this study to compare safety and efficacy to the FDA approved Watchman device. The study expects to enroll 1600 subjects at about 150 study centers around the world.

This study is currently enrolling new patients.

PREVENT VT - Prophylactic Cervicothoracic Sympathectomy for Prevention of Ventricular Tachycardia

The purpose of this study to evaluate an additional therapy option for recurrent ventricular tachycardia (VT) called cervicothoracic sympathectomy (CTS). Research has shown that a group of nerves called a ganglia feeding the lower chambers of the heart (ventricles) help start and maintain VT. A surgical procedure called CTS removes a section of these nerves. The goal of this study is to determine whether CTS can prevent VT from occurring, and therefore prevent ICDshocks.

QDOT - Evaluation of QDOT MICRO™ catheter for pulmonary vein isolation (PVI) in subjects with Paroxysmal Atrial Fibrillation (PAF)

The purpose of this study is to provide information about the safety and long-term effectiveness of the QDOT MICRO™ (QDOT) Catheter for the treatment PAF. The QDOT catheter uses RF ablation technology, to create lesions that destroy the tissue causing irregular electrical circuits. The electrodes are cooled by a flow of saline-based solution originating from small holes in the tip of the catheter electrode. The QDOT catheter uses temperature feedback measured at the tip to adjust power and irrigation flow.

About 185 patients at up to 30 centers in the US will take part in this study and participation may last up to 1 year

St. Jude AMULET - Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial

This study is for patients that have nonvalvular atrial fibrillation (AF) and are scheduled to receive a Boston Scientific WATCHMAN LAA occluder device. It is evaluating the AMPLATZER™ Amulet™Left Atrial Appendage Occluder device (AMULET). Like the WATCHMAN device, the AMULET device is designed to reduce the risk of a blood clot from the left atrial appendage (LAA). This purpose of this prospective, randomized, multicenter, active control worldwide trial is to find out if the AMULET device is safe and effective when compared to the WATCHMAN.

This study is currently in follow-up only and is not enrolling new patients.

STELLAR - Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

This study evaluates an investigational device, the Multi-Electrode Radiofrequency (RF) Balloon catheter system (used with the Multi-Electrode Circular Diagnostic catheter, Multi-Electrode RF Generator, CARTO® software, and irrigation pump) for the treatment of subjects with paroxysmal atrial fibrillation (PAF). The Multi-channel RF Generator and irrigation pump are approved in Europe.

Up to 640 people in up to 40 clinical sites in the US and outside the US will take part in this study.

Tactiflex SE - Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation

This study is for patients that are scheduled to undergo Atrial Fibrillation (AF) ablation procedure. The purpose of this study is to demonstrate that the investigational TactiFlex Sensor Enabled catheter is both safe and effective. The catheter makes use of a sensor to measure the contact force being applied throughout the ablation as well as a magnetic sensor used for tracking with the Ensite Precision Mapping System. This study will enroll 355 patients at up to 40 sites worldwide. Involvement lasts approximately 12-months from the time of the ablation procedure.

This study is currently enrolling new patients.

TANTRA II - PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-Term Recurrence-Free Survival in Non-Paroxysmal Atrial Fibrillation (AF)

The purpose of this study is to evaluate the effect of scar ablation (homogenization) and non-pulmonary vein (PV) trigger ablation on the success rate of the ablation procedure. Abnormal heart rhythms can be triggered from sites other than pulmonary veins (the most common sites of origin for AF). These are termed as non-PV triggers. The purpose of this study is to evaluate the effect of scar ablation (homogenization) and non-PV trigger ablation on the success rate of the ablation procedure. There are three different ablation strategies for this study. These include: (1) Pulmonary vein isolation (PVI) plus isolation of left atrial posterior wall (PWI), (2) PVI+ scar homogenization, and 3) PVI + PWI + ablation of non-PV triggers. The study will enroll 186 patients in the Austin area and participation will last 3 years.

ViralClear - A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients with Advanced Coronavirus Disease 2019 (COVID-19)

This study is for participants who are in the hospital with the COVID-19 virus infection and need additional oxygen. Currently, there are no therapies approved by the United States Food and Drug Administration (FDA) for treating patients with this infection. However, the FDA has given permission for emergency use of remdesivir to treat patients with severe COVID19 which in clinical trials has shown to decrease the death rate from 11% to 8%. The purpose of this study is to compare the effects of merimepodib (MMPD), an investigational broad-spectrum antiviral medication, given together with remdesivir vs. remdesivir alone and assess the safety of MMPD. This study will enroll approximately 80 patients at hospitals around the US and participation in this study will last up to 60 days.

This study is currently enrolling new patients.

 

VISITAG - Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI)

The purpose of this study is to evaluate the safety and effectiveness of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with a THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheter. The VISITAG SURPONT system has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of PAF when used with THERMOCOOL STSF and THERMOCOOL ST catheters.

This study is currently in follow-up only and is not enrolling new patients.

WAVECREST - WaveCrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediate Stroke 2

This randomized study will enroll patients who have nonvalvular atrial fibrillation (AF) and are scheduled to receive an LAA occluder device. AF increases the risk for blood clots forming in the LAA due to slower blood flow. The LAA is a small pouch on the left upper chamber of your heart called the left atrium. Blood clots in the left side of the heart may go to the brain and cause a stroke. Closing the LAA might prevent blood clots from forming and escaping the LAA.

The purpose of this study is to evaluate the safety and effectiveness of the Coherex WaveCrest® Left Atrial Appendage (LAA) Occlusion System (“WaveCrest device”) by comparing it to a similar device, the Watchman device. The WaveCrest device is investigational, which means it is not approved by the FDA for commercial use in the United States.

Watchman FLX2 - Protection against Embolism for non-valvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN FLX™ LAAC Device in patients with non-valvular atrial fibrillation who require treatment for potential blood clot (thrombus) formation in the LAA. The WATCHMAN FLX™ LAAC Device is intended to prevent clots that originate from the LAA from dislodging and leading to potential stroke. These devices also potentially allow patients to stop taking their blood thinner, also known as anticoagulant. This device is investigational, which means it has not been approved by the FDA and is being evaluated in this study to compare safety and efficacy to the FDA approved Watchman device.

This study is currently in follow-up only and is not enrolling new patients.

ZODIAC - Pulmonary Vein reconnection after Pulmonary Vein Antrum Isolation at different power settings using adenosine provocation

This is a prospective, randomized, multi-center study is designed to find the optimal ablation energy strategy, and compare the rate of atrial fibrillation (AF) recurrence following ablation of the pulmonary veins (PVs) and posterior wall. The ablation is performed at different energy settings, 30 watts versus 40 watts.