Texas Cardiac Arrhythmia

The purpose of this prospective, randomized trial is to determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD / CRTD patients with an impaired left ventricular function. Success will be defined by recurrence of AF, quality of life, 6-minute walk distance, heart pump function, and total number of hospitalizations.

This prospective, randomized, blinded study sponsored by St Jude Medical is designed to evaluate a pacemaker software feature used to suppression atrial fibrillation (AFib -arrhythmia in the upper chambers of the hearts) called AF Suppression. Patients with high blood pressure, heart failure, and / or coronary artery disease and over the age of 59 are included. Additional evaluation includes the effect of anti-arrhythmic medications (AAD’s), and the frequency and duration of AFib episodes.

This prospective, randomized, blinded trial sponsored by St. Jude Medical is designed to evaluate the effectiveness of a device feature called “AF suppression” in patients receiving an implantable cardioverter defibrillator (ICD). “AF Suppression” involves pacing the upper chambers of the heart in order to reduce the risk of developing AF. Patients with a history of atrial fibrillation (AFib – an arrhythmia in the upper chambers of the heart) are randomized to have AF suppression turned “ON” or “OFF”.

This FDA IDE trial evaluates an ablation catheter used with laser energy intended for use in the treatment of paroxysmal atrial fibrillation (PAF). The purpose of this study is to assess the safety and effectiveness of the CardioFocus Ablation catheter by creating electrical isolation on the pulmonary veins for the treatment of symptomatic PAF in patients who are refractory to or intolerant of anti-arrhythmic drugs (AAD). This prospective, randomized, unblinded, multi-center trial will enroll 180 subjects in a 1.4:1 fashion. Control group will be managed medically (AAD’s). Control subject will be eligible for ablation upon meeting failure criteria after a 90 blanking period.

The purpose of this prospective, randomized, double-blind clinical trial sponsored by Medtronic, Inc. is designed to assess the effectiveness of the Chronicle software used in conjunction with an ICD (Implantable Cardioverter Defibrillator).
This investigational device includes the Chronicle Implantable Hemodynamic Monitor (IHM) which is that is designed to continuously track intracardiac pressure, body temperature, physical activity and heart rate in patients with heart failure. With this device, physicians and staff can monitor a patient’s heart pressure and other vital signs via the Internet.

CONNECT is a post-market study designed to evaluate the benefits of the ConcertoTM /VirtuosoTM Remote Management System (ConexusTM + CareAlertsTM + CareLink®). Patients are randomized to be followed using remote technology or routine doctor’s office visits. Primary objectives include demonstration that the remote management system reduces the time to clinical decision for arrhythmias, cardiovascular disease progression, and system issues compared to subjects receiving only in-office care.

Additional objectives include characterizing Healthcare Utilization (hospitalizations, ER visits, office visits), Medtronic CareLink® compliance (reduced clinic burden in getting routine device interrogations), Clinic personnel satisfaction with wireless ECG (clinician user survey), Patient Well Being (anxiety, peace of mind, illness intrusiveness), Left Ventricular Capture Management (LVCM) feature (variability in the LV threshold over time), and In-office Follow-up Burden

This prospective, randomized, blinded study sponsored by St Jude Medical is designed to evaluate a pacemaker software feature used to suppression atrial fibrillation (AFib -arrhythmia in the upper chambers of the hearts) called AF Suppression. Patients with high blood pressure, heart failure, and / or coronary artery disease and over the age of 59 are included. Additional evaluation includes the effect of anti-arrhythmic medications (AAD’s), and the frequency and duration of AFib episodes.

This prospective, non-randomized trial sponsored by Medtronic, Inc. is designed to characterize the utility of fluid status trending in heart failure patients with a Implantable Cardioverter Defibrillator (ICD). The software feature called ‘Thoracic Fluid Status’ is downloaded into previously implanted ICD’s to continuously collect impedance trend data. Objectives for the trial are to present trends with annotations for all clinically relevant events, and to characterize the trends before and after treatment for heart failure with signs and/or symptoms of pulmonary congestion.

This randomized, double-blind study sponsored by Impulse Dynamics, Inc. is being conducted to evaluate the safety and efficacy of a pacemaker-like device designed to treat heart failure by stimulating the intraventricular septum (wall between the lower chambers of the heart). Cardiac contractility modulation (CCM) stimulates the heart between normal heartbeats. This technology is evaluated in heart failure patients with are receiving optimal heart failure medications, and are not candidates for bi-ventricular pacing (CRT). The Control group remains optimized on heart failure medication.

This prospective, randomized trial sponsored by ProRhythm, Inc. is designed to evaluate the safety and efficacy of the HIFU (High Intensity Focused Ultrasound) ablation catheter system for the treatment of atrial fibrillation. The control group receives anti-arrhythmic drugs (AAD’s). ‘Cross-over’ to the HIFU arm is possible if AAD’s fail to treat the atrial fibrillation.

This prospective, double-blinded randomized study is designed to demonstrate that frequent AV/PV and VV delay optimization using QuickOpt in patients with a CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one time optimization using any non-IEGM optimization methods)

Group 1 – Programmed to sequential BiV pacing mode with AV/PV and VV delays optimized using QuickOpt every 3 months
Group 2 – Programmed to either simultaneous or sequential BiV pacing mode. Programmed empirically or optimized using non-IEGM method per standard of care. At Texas Cardiac Arrhythmia, this would mean using echocardiography to optimize programming.

Endpoints include an Heart Failure clinical composite score, all cause – cardiovascular and heart failure mortality, and all cause – cardiovascular and heart failure hospitalizations

This experimental, non-randomized, open label, download, pilot trial will collect preliminary observations about the function of new algorithms designed to pace only the LV with various intervals to create synchrony with the RV in CHF patients with an existing CRT-ICD, with the goal of allowing use of the patient’s His-Purkinje system, and decreasing drain on the battery. Up to 30 patients may participate in this study.

Objectives include characterizing Fusion Pacing algorithm performance in patients with intact AV conduction and CRT-ICD systems, determining percent of time Fusion Pacing is active throughout an approximate 3-month follow-up period, and documenting AV conduction profiles in CRT patients receiving fusion pacing.

At enrollment, echo will be used to optimize pacing. Sub-max treadmill testing and holter monitoring will be used to collect data. Patients will return at 2 weeks and 3 mths for device data collection. The experimental software will re removed form the device at the 3 month visit.

A prospective, randomized, feasibility study to be conducted using a new radio-frequency (RF) catheter and generator to treat persistent atrial fibrillation feasibility study using the Gen2 Cardiac Ablation System. Randomization will occur between having the investigator use a manual power mode vs a temperature mode to create the RF lesions. The objective is to demonstrate the initial safety and initial acute efficacy of the Gen2 Cardiac Ablation System in order to determine if a pivotal trial is warranted.

The GAME study is a retrospective case control study design involving a single blood draw and a 24 hour holter monitor from case subjects who have experienced a life-threatening arrhythmia (LTA) and control subjects who have no evidence of LTAs.

The primary objective is to determine the feasibility of utilizing genetic markers to identify individuals in need of an ICD (Implantable Cardioverter Defibrillator). Secondary objectives include identifying genes associated with SCD susceptibility, and risk factors for SCD as found in the CRF information, as well as correlating SNPs with co-morbidities in the subjects as found in the CRF information, and the parameters derived from the DR 190 Holter recording to search for association with SCD.

This prospective, randomized, blinded trial sponsored by Medtronic is designed to evaluate the effects of 2 different pacing software algorithms on the progression of heart failure and occurrence of death in patients with a clinical indication for an Implantable Cardioverter Defibrillator (ICD). Recent trials of ICD and pacing therapy have demonstrated that ventricular pacing (in the lower heart chambers) can negatively affect heart function over time. The purpose of the trial is to determine if ICD patients will benefit from Managed Ventricular Pacing (MVP) programming compared to VVI 40 pacing as evidenced by equivalence in the or by slowing in the progression of heart failure.

The purpose of this prospective, non-randomized study is to provide additional, corroborative safety data for the NaviStar ThermoCool catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease. The primary safety endpoints are 12-month all cause mortality and the percentage of subjects experiencing cardiovascular-specific adverse events (CSAE) within seven (7) days of the ablation procedure.

This prospective, multi-center, randomized (1:1), investigational device exemption (IDE) study will collect data required to determine whether the use of Cardiac Compass including OptiVol Fluid Status Monitoring with standard clinical assessment will result in a longer time to 1st HF hospitalization or death compared to standard clinical assessment alone (“Control Arm”) and to support the approval of the OptiVol Alert (audible and home monitor alerts) & SentryCheck™ Monitor, and the OptiVol Alert Suspend & Reference Impedance Adjustment (OptiVol enhancements). Goals include demonstration of a longer time to first HF hospitalization or death, and that the proportion in the Access Arm experiencing a safety event is not worse than subjects in the Control Arm

Additional objectives include demonstrating a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations, cardiovascular hospitalizations, HF hospitalizations, the duration of HF related hospitalizations, all HF related hospitalizations, ED visits, urgent and non-urgent unscheduled office visits, and all-cause mortality.

This prospective data collection study using commercially approved product is designed to collect imaging data during an electrophysiology study of the left atrium. Creation of the image occurs by integrating a CT image with NavX intracardiac mapping data. The objective of this study is to determine the clinical accuracy of registration using EnSite Fusion for real-time navigation in the left atrium

This prospective, randomized trial sponsored by Atritech, Inc is designed to evaluate the safety and effectiveness of the WATCHMAN device. The device occludes the left atrial appendage (pouch) in the heart and is designed to prevent stroke in patients with atrial fibrillation who are currently taking blood thinning medications to guard against stroke.

The purpose of this prospective registry is designed to study patterns of use with LATITUDE system.

The LATITUDE® with wireless radio frequency (RF) telemetry, and home monitoring equipment including a weight scale, and blood pressure monitor will be used to automatically send data through the LATITUDE Communicator to the physician’s office.

Goals include characterizing LATITUDE Active Monitoring by evaluating type and frequency of alert notifications, time from alert notifications to medical intervention, and type of medical intervention implemented for activated alerts, and evaluating clinical outcome data by assessing mortality, NYHA class and QOL changes over time, hospitalizations and HF-related events.

This prospective, blinded, randomized trial sponsored by Medtronic, Inc. is designed to evaluate a group of pacemaker features called intervention pacing. These features are designed to reduce the frequency of abnormally fast arrhythmias in the upper chambers of the heart by pacing slightly faster than the normal rate. Also, intervention pacing will attempt to prevent the atria from experiencing pauses caused by irregular beats.

Also, this study will evaluate the performance of the intervention pacing features by pacing the atria (upper chambers) on the wall that divides the upper 2 chambers of the heart. Patients are randomized to have these features turned ON or OFF. A hand held monitor called the “Patient Assistant” is also used to communicate with the pacemaker as symptoms occur.

This prospective, randomized, double-blind trial sponsored by Medtronic, Inc. is designed to determine whether Cardiac Resynchronization Therapy (CRT) will result in a stabilization or improvement in patient clinical status as compared to optimal medical therapy (medications) alone in patients with asymptomatic or mild heart failure and an electrical conduction delay. CRT involves pacing both lower chambers of the heart to ‘synchronize’ the pumping action of the heart.

The study is the first ambulatory evaluation of the ST Detection algorithm in the target patient population of 200 patients. Intra-cardiac electrograms and heart sounds will be collected by uploading an investigational algorithm into a Virtuoso® ICD. This multi-center, non-randomized feasibility study will evaluate the performance of the algorithm during a 6 month FU period. The primary objective is to collect ambulatory ST segment changes associated with spontaneous coronary events and exercise-induced cardiac ischemia in an ICD-indicated coronary artery disease (CAD) population.

Additional objectives include characterization of the rate of occurrence of spontaneous coronary events and all other cardiac events in ICD-indicated coronary artery disease subject population at risk for ischemia, and the EGM-based ST segment changes measured during spontaneous coronary events and exercise-induced ischemia and compare them to ST segment changes measured by the 12-lead ECG, as well as development of an EGM database of ambulatory signals, including signals captured during spontaneous coronary events and exercise-induced cardiac ischemia, and evaluation of the ability of the device’s Patient Alert microphone to record heart sounds in a subset of subjects