Clinical trials: Cardiac Resynchronization
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
Post Market Surveillance Study Following Clinical Routine
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not…
- Trial name
- Rally CRT-P (NCT02488239)
- Testing
- CRT-P indicated patients
- Where
- 8 sites in Finland, Germany
- Volunteers
- 64 people
- Sponsor
- Boston Scientific Corporation
Cardiovascular Disease
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for…
- Trial name
- NCT00856349
- Testing
- Therapy Programming Report (TPR)
- Where
- 104 sites in United States, Argentina and 10 more
- Volunteers
- 4,384 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the…
- Trial name
- NCT01475175
- Testing
- CRT pacing at rest and during exercise
- Where
- 7 sites in Austria, Belgium and 4 more
- Volunteers
- 12 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiomyopathy
Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy
The purpose of this trial or study is to determine if cardiac resynchronization therapy (CRT) can be a benefit to people who have impaired heart function due to past treatment with chemotherapy and/or chest radiation.
- Trial name
- MADIT-CHIC (NCT02164721)
- Testing
- Three-lead CRT-D (Defibrillator)
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Rochester
Systolic Heart Failure, Cardiac Resynchronization Therapy
ECG for Programming in CRT
Patients with heart failure and left bundle branch block benefit from Cardiac Resynchronization Therapy (CRT) that delivers pacing from right ventricle (RV) and left ventricle (LV) synchronously, resulting in electrical…
- Conditions
- Systolic Heart Failure, Cardiac Resynchronization Therapy, Electrocardiography
- Trial name
- EPIC (NCT03936608)
- Testing
- Programming individualized RV-LV pacing offset to optimize ECG, Nominally programming CRT device without RV-LV offset
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Washington University School of Medicine
Sudden Cardiac Death
'Effect of CRT on Defibrillation Threshold Estimates' Study
The purpose of this prospective study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization therapy defibrillators (CRT-D) patients.
- Trial name
- NCT00626093
- Testing
- Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
- Where
- 2 sites in United States
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Congenital Heart Defects
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Malformations of the heart (congenital heart disease) are the most common congenital birth defects, occurring in about 1% of children.
- Trial name
- NCT00397514
- Testing
- Congenital Heart Surgery Patients
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of British Columbia
Sudden Cardiac Death, Heart Failure
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these…
- Trial name
- NOTICE-HF (NCT01227785)
- Testing
- INCEPTA ICD or CRT-D
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Heart Failure
Leadless Electrocardiogram (ECG) Evaluation Study
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG…
- Trial name
- LECG (NCT01297283)
- Testing
- LECG first, Programmer ECG first
- Where
- France
- Volunteers
- 195 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Cardiac Resynchronization in the Elderly
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare…
- Trial name
- NCT03031847
- Testing
- Cardiac Resynchronization Therapy Pacemaker, Cardiac Resynchronization Therapy Defibrillator
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- Samir Saba
Postoperative Cardiac Complication, Heart Failure
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and…
- Conditions
- Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation
- Trial name
- MORE-CRT (NCT01510652)
- Testing
- BiP Group, Quad Group
- Where
- 64 sites in Belgium, Canada and 11 more
- Volunteers
- 1,078 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices.
- Trial name
- NCT00187200
- Testing
- Simultaneous VV Pacing, Sequential VV Pacing
- Where
- United States
- Volunteers
- 816 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
- Trial name
- EXPECT (NCT01520714)
- Testing
- Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Baylor Research Institute
Heart Failure
Sensor Optimization of Cardiac Resynchronization Therapy Response
The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds…
- Trial name
- SOCR (NCT01832493)
- Testing
- Cardiac Resynchronization Therapy
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
QuickFlex Micro Left Ventricular Lead Post Approval Study
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
- Trial name
- NCT01179477
- Testing
- Implantation of a QuickFlex® μ Model 1258T LV Lead
- Where
- 77 sites in United States
- Volunteers
- 1,930 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population.
- Trial name
- NCT00763698
- Testing
- QuickFlex Micro Model 1258T Left Heart Lead
- Where
- 13 sites in United States
- Volunteers
- 86 people
- Sponsor
- Abbott Medical Devices
Magnetic Resonance Imaging
ENABLE MRI (Magnetic Resonance Imaging)
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled…
- Trial name
- ENABLE-MRI (NCT02652481)
- Testing
- ImageReady MR Conditional Defibrillation System
- Where
- 57 sites in United States, Belgium and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation