Clinical trials: Resynchronization Therapy
Heart Failure
Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates
The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead…
- Trial name
- ENVISION (NCT01278030)
- Testing
- 3D echo-guided LV lead placement
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Right Bundle-Branch Block
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)
Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis.
- Trial name
- PACE-RBBB (NCT01169493)
- Testing
- VVI-40, RV DDD-40, BiV DDD-40
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Duke University
Cardiac Resynchronization Therapy
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation…
- Trial name
- NAVIGATE X4 (NCT02071173)
- Testing
- ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
- Where
- 96 sites in United States
- Volunteers
- 2,244 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Ventricular Dyssynchrony
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication…
- Trial name
- EchoCRT (NCT00683696)
- Testing
- Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
- Where
- 122 sites in United States, Australia and 15 more
- Volunteers
- 1,680 people
- Sponsor
- Biotronik, Inc.
Heart Failure
Attain Performa(TM) Quadripolar Lead Study
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure.
- Trial name
- NCT01751022
- Testing
- Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
- Where
- 121 sites in United States, Australia and 25 more
- Volunteers
- 1,202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Cardiac Resynchronization Therapy, Chronic Heart Failure
Exercise Training Following Cardiac Resynchronization Therapy in Patients With Chronic Heart Failure
Cardiac resynchronization therapy(CRT) is recommended to reduce mortality and morbidity in chronic heart failure(CHF) patients New York Heart Association(NYHA) class III-IV who are symptomatic despite optimal medical therapy…
- Trial name
- NCT02413151
- Testing
- Exercise training program, Cardiac resynchronization therapy (CRT)
- Where
- Portugal
- Volunteers
- 62 people
- Sponsor
- University of Lisbon
Non-left Bundle Branch Block, Ischemic or Non-ischemic Cardiomyopathy
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population.
- Trial name
- ENHANCE CRT (NCT01983293)
- Testing
- QLV based implant strategy, Standard of care implant strategy
- Where
- 32 sites in United States
- Volunteers
- 248 people
- Sponsor
- Abbott Medical Devices
Heart Failure
OptiVol® Care Pathway
Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States.
- Trial name
- NCT00847288
- Testing
- Monthly Review Arm, Quarterly Review Arm
- Where
- 108 sites in United States
- Volunteers
- 1,682 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Heart Failure
ECG Belt to Assess Electrical Synchronization
The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of Left Bundle Branch Pacing (LBBAP) and His-Optimized Cardiac Resynchronization Therapy (HOT-CRT) and compare…
- Trial name
- NCT04583709
- Testing
- ECG Belt
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Pugazhendhi Vijayaraman
Atrial Fibrillation
Cardiac Resynchronization Therapy Efficacy Enhancements
The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the…
- Trial name
- CRTee (NCT02222818)
- Testing
- Conducted AF Response (CAFR), Conducted AF Response Plus (CAFRPlus)
- Where
- 19 sites in United States, Hungary and 5 more
- Volunteers
- 71 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Comparison of AV Optimization Methods Used in Cardiac Resynchronization Therapy (CRT)
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a…
- Trial name
- SMART-AV (NCT00677014)
- Testing
- AV Delay programming through cardiac resynchronization therapy
- Where
- United States
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
Ventricular Arrhythmia
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing…
- Trial name
- TEMPO (NCT02104583)
- Testing
- Eleclazine
- Where
- 84 sites in United States, Canada and 7 more
- Volunteers
- 313 people
- Sponsor
- Gilead Sciences
Heart Failure
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with…
- Trial name
- QUARTO_III (NCT02476201)
- Testing
- MPP ON
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Model 4396 Left Ventricular (LV) Lead Study
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective.
- Trial name
- 4396 (NCT00853593)
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 197 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Quadripolar CRT-D On Currently Approved Lead SystemS
The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
- Trial name
- CROSS X4 (NCT02232984)
- Where
- 60 sites in United States
- Volunteers
- 749 people
- Sponsor
- Boston Scientific Corporation
Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
- Trial name
- ERASE (NCT04600921)
- Testing
- Ertugliflozin 5 mg
- Where
- 8 sites in Austria
- Volunteers
- 55 people
- Sponsor
- Medical University of Graz
Heart Failure
Attain Stability™ Quad Clinical Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
- Trial name
- NCT03099655
- Testing
- Attain Stability Quad Left Ventricular Pacing Lead
- Where
- 50 sites in United States, Canada and 8 more
- Volunteers
- 471 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
The goal of this study is to compare the effectiveness of pacing from a physiologic His bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in subjects with heart failure undergoing cardiac…
- Trial name
- His-SYNC (NCT02700425)
- Testing
- CRT Pacemaker
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of Chicago
Heart Failure
Quartet Lead and Resynchronization Therapy Options
The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four…
- Trial name
- QUARTO (NCT01295840)
- Testing
- Cardiac Resynchronization Therapy Defibrillator
- Where
- Spain
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices