Clinical trials: Resynchronization Therapy
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
Congestive Heart Failure
COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac…
- Trial name
- NCT00396136
- Testing
- Corox OTW Steroid Left Ventricular Lead
- Where
- United States
- Volunteers
- 221 people
- Sponsor
- Biotronik, Inc.
Heart Failure
Adaptive Cardiac Resynchronization Therapy Study
The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance
- Trial name
- aCRT (NCT00980057)
- Testing
- Adaptive CRT (aCRT), Echo
- Where
- 105 sites in United States, Australia and 17 more
- Volunteers
- 522 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
- Trial name
- PEGASUS CRT (NCT00146848)
- Testing
- Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
- Where
- United States
- Volunteers
- 1,742 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Congestive Heart Failure
MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator (ICD)-cardiac resynchronization therapy (CRT-D) will reduce the risk of mortality and heart failure (HF) events by approximately 25%, in…
- Trial name
- MADIT-CRT (NCT00180271)
- Testing
- Cardiac resynchronization therapy with defibrillation, Implantable Cardioverter Defibrillator (ICD)
- Where
- United States
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
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
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure，Congestive, Cardiomyopathies
HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy
This is a randomized, prospective, single-blinded trial to determine the overall rate of successful His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT) versus biventricular pacing…
- Conditions
- Heart Failure，Congestive, Cardiomyopathies, Left Ventricular Dysfunction
- Trial name
- HOT-CRT (NCT04561778)
- Testing
- HOT-CRT, Biventricular Pacing
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Pugazhendhi Vijayaraman
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
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
Heart Failure
Attain Model 4196 Left Ventricular (LV) Lead
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
- NCT00271544
- Testing
- Pacing Lead
- Where
- 24 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
- Trial name
- SMART CRT (NCT03089281)
- Testing
- CRT-D
- Where
- 72 sites in United States, Canada and 9 more
- Volunteers
- 699 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Heart Failure
Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.
- Trial name
- Promote Q (NCT00990665)
- Testing
- CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
- Where
- 24 sites in United States
- Volunteers
- 178 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Model 4296 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. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms.
- Trial name
- 4296 (NCT00927251)
- Testing
- Pacing Lead (Model 4296 LV Lead)
- Where
- 16 sites in Austria, Finland and 6 more
- Volunteers
- 90 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia
Safety and Performance Study of the Reliance 4-Front Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.
- Trial name
- NCT01772576
- Testing
- Reliance 4-Front lead implantation
- Where
- 15 sites in Austria, China and 9 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Cardiac Arrhythmia
SJM MRI Diagnostic Imaging Registry (IDE)
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically…
- Trial name
- NCT02807948
- Testing
- Pacemaker, ICD, or CRT device
- Where
- 58 sites in United States
- Volunteers
- 189 people
- Sponsor
- Abbott Medical Devices
Heart Failure
A Pilot Study of Interventricular Septal Puncture for Cardiac Resynchronization Therapy to Treat Heart Failure
Cardiac resynchronization therapy (CRT) is known to result in significant improvement in the symptoms of selected patients with heart failure, and to reduce hospital admission and death rates in these patients.
- Trial name
- LV-CONSEPT (NCT01818765)
- Testing
- Trans-ventricular-septal placement of LV pacing lead, Pre-procedure speckle-tracking echocardiography, Acute response assessment
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Oxford University Hospitals NHS Trust
Heart Failure
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex.
- Trial name
- V3 (NCT01059175)
- Testing
- Additional Endocardial or Epicardial LV Lead, CRT-P or CRT-D
- Where
- France
- Volunteers
- 84 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing…
- Trial name
- SYNSEQ (NCT02914457)
- Testing
- Electrophysiological Study
- Where
- 7 sites in Poland, Slovakia and 3 more
- Volunteers
- 31 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure Treated
Clinical Benefits in Optimized Remote HF Patient Management
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or…
- Trial name
- COR-HF (NCT01482598)
- Testing
- Remote Care Follow up
- Where
- 18 sites in Italy
- Volunteers
- 144 people
- Sponsor
- Abbott Medical Devices