Clinical trials: Cardiac Resynchronisation Therapy (CRT)
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
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, ICD
Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient cardiovascular health and quality of life.
- Conditions
- Heart Failure, ICD, Chronotropic Incompetence
- Trial name
- CLASS (NCT02693262)
- Testing
- CLS Mode on Biotronik CRT-D, Accelerometer Mode on Biotronik CRT-D
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Heart Failure
QuickOpt Chronic Study
The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the…
- Trial name
- NCT01172067
- Testing
- Cardiac Resynchronization Therapy, Optimization using echocardiography
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular Fibrillation
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Trial name
- NCT01856491
- Testing
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Where
- 11 sites in Germany, Israel and 1 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Congestive Heart Failure, Cardiac Resynchronization Therapy
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted…
- Trial name
- NCT00395642
- Testing
- Kronos LV-T, Lumax HF-T
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- Biotronik, Inc.
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
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
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, Ventricular Arrythmias
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices.
- Trial name
- NCT00746356
- Testing
- Testing of the autocapture features of the device
- Where
- 5 sites in United States
- Volunteers
- 128 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiomyopathy
InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00273182
- Testing
- InSync Model 8040, InSync III Model 8042
- Where
- 82 sites in United States
- Volunteers
- 1,999 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes
This is a research study that is evaluating blood markers which may predict which patients who receive CRT will improve. Congestive heart failure (CHF) is associated with increased oxidative stress, a condition where abnormal…
- Trial name
- NCT01151553
- Testing
- CRT Therapy
- Volunteers
- 5 people
- Sponsor
- Emory University
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.
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure
Biventricular Versus Right Ventricular Pacing
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist…
- Trial name
- NCT06298669
- Testing
- Biventricular Pacing, Right Ventricular Pacing
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Indiana University
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
Heart Failure
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device…
- Trial name
- NCT02698241
- Testing
- Diagnostic & Medication Management
- Where
- 8 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CARE-HF Long Term Follow-up
The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up.
- Trial name
- NCT00318357
- Testing
- Continuation of CRT, Upgrade to CRT
- Where
- United Kingdom
- Volunteers
- 309 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure