Clinical trials: Resynchronization Therapy
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
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Hypertrophic Cardiomyopathy With Obstruction
Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
This investigation is a prospective, randomized, single-blinded and multicenter design. The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular (BiV) pacing in severely symptomatic hypertrophic…
- Trial name
- TRICHAMPION (NCT01614717)
- Testing
- CRT-P Implant
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Left Bundle-Branch Block
LV Only MPP With SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy…
- Trial name
- NCT03567096
- Testing
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
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
Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study
The purpose of this study is to collect and analyze electrical measurements, timing, and signals from a CRT-D device in heart failure patients who either already have an implanted left atrial pressure sensor or will undergo a…
- Trial name
- zLAP (NCT00632372)
- Testing
- Cardiac Resynchronization Therapy, HeartPOD™ System
- Where
- 10 sites in United States, New Zealand
- Volunteers
- 8 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure - NYHA II - IV
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left…
- Trial name
- SYNCHRONICITY (NCT07069738)
- Testing
- CRT-D with a Quadripolar LV lead, CRT-D with INGEVITY+ pace/sense lead
- Where
- 42 sites in United States
- Volunteers
- 850 people
- Sponsor
- Boston Scientific Corporation
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Clinical Investigation of the Medtronic Concerto™ Device
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
- NCT00268320
- Testing
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Where
- 51 sites in United States, Austria and 10 more
- Volunteers
- 270 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve…
- Trial name
- CRT-Narrow (NCT00821938)
- Testing
- LV dp/dt pressure measurement
- Where
- Germany
- Volunteers
- 30 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
Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
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
- NCT00268281
- Testing
- Left Ventricular Capture Management Software
- Where
- 18 sites in United States
- Volunteers
- 107 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
Heart Failure
Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.
- Trial name
- NCT01519739
- Testing
- MediGuide™
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Attain StarFix™ Model 4195 Left Ventricular Lead
People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator.
- Trial name
- NCT00269230
- Testing
- Pacing Lead
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 441 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure