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
Non Ischemic Cardiomyopathy
Magnetic Resonance Imaging Based Risk Stratification for Defibrillator Implantation in Heart Failure Patients Requiring Cardiac Resynchronisation Therapy
This randomized study aimed to compare the efficacy of LBBP without defibrillator vs biventricular pacing with defibrillator (BiV-ICD/CRT-D) in patients with LB-NICM and left ventricular ejection fraction (LVEF) ≤35% risk…
- Trial name
- MADURAI CRT (NCT07791407)
- Testing
- left bundle branch pacing, Biventricular pacing with defibrillator
- Where
- India
- Volunteers
- 114 people
- Sponsor
- Velammal Medical College Hospital and Research Institute
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
Heart Failure With Reduced Ejection Fraction
CPET Predicts Long-term Survival and Positive Response to CRT
The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.
- Trial name
- CPET-CRT (NCT03870074)
- Volunteers
- 122 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
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
Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients
Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy.
- Trial name
- CRT-LVAD (NCT02169076)
- Testing
- Cardiac Resynchronization Therapy
- Where
- United States
- Sponsor
- University of Louisville
Cardiac Resynchronization Therapy
cArdiac Non Invasive MApping in resynchronizaTION
Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular…
- Trial name
- ANIMATION (NCT04347109)
- Testing
- Non invasive epicardial mapping
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Tours
Heart Failure With Reduced Ejection Fraction (HFrEF)
Correlation of Typical LBBB Mechanical Activation Pattern by 2D Strain Echocardiography With Acute GWE Improvement in Patients Receiving LBBp or Conventional BiVp for Cardiac Resynchronization Therapy (Echo LBBp)
The present study is a multicenter interventional non randomised study in patients requiring an implantable device for cardiac resynchronization therapy.
- Trial name
- ECHO-LBBp (NCT06689111)
- Testing
- Left bundle branch pacing lead, CRT with the standard method through cs
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University Hospital of Patras
Cardiovascular Diseases, Arrhythmias, Cardiac
Multicenter Evaluation of Patients Using LATITUDE Monitoring System
The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Heart Failure, Sudden Cardiac Death
- Trial name
- Multitude (NCT06311149)
- Where
- 3 sites in Italy
- Volunteers
- 20,000 people
- Sponsor
- University Hospital of Ferrara
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
Bundle-Branch Block
The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)
In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical activation of the left heart chamber will cause abnormal contraction.This has been shown to be possible to treat by a special pacemaker…
- Trial name
- NCT00192946
- Testing
- Temporary cardiac resynchronization therapy
- Volunteers
- 60 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Atrial Tachycardia
PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias
Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia.
- Trial name
- NCT05344456
- Testing
- Change in the device PVC algorithm to ''Off''
- Where
- Finland
- Volunteers
- 16 people
- Sponsor
- Helsinki University Central Hospital
Heart Failure, Left Bundle Branch Area Pacing
A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone
Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy and may offer advantages over conventional biventricular pacing (BVP), including improved clinical outcomes.
- Conditions
- Heart Failure, Left Bundle Branch Area Pacing, Cardiac Resynchronization Therapy, Conduction System Pacing
- Trial name
- LOT or NOT (NCT07842874)
- Testing
- LOT-CRT-P (Programming: LBBAP), LOT-CRT-P (Programming: LOT-CRT-P)
- Where
- Germany
- Volunteers
- 124 people
- Sponsor
- PD Dr. Guram Imnadze
Non-ischemic Cardiomyopathy, Cardiac Resynchronisation Therapy (CRT)
Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy.
Multicenter, prospective, non-inferiority, randomized, single-blind (primary endpoint evaluators blinded, patients not blinded) clinical trial.
- Trial name
- DRUGLESS-CRT (NCT07851779)
- Testing
- Withdrawal of Heart failure medications
- Where
- 4 sites in Spain
- Volunteers
- 64 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
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
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
Heart Failure, Arrhythmia
Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long term despite the use of many effective drug treatment in reducing morbidity and mortality.
- Trial name
- CHLOVIS (NCT01841242)
- Testing
- alcoholic povidone iodine, alcoholic chlorhexidine
- Where
- 24 sites in France
- Volunteers
- 2,272 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
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