Clinical trials: Pacing Therapy
Bradycardia, Heart Failure
ECG Belt to Assess Electrical Synchronization
The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of Left Bundle Branch Pacing (LBBAP) and His-Optimized Cardiac Resynchronization Therapy (HOT-CRT) and compare…
- Trial name
- NCT04583709
- Testing
- ECG Belt
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Pugazhendhi Vijayaraman
Heart Failure With Reduced Ejection Fraction
Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure
Randomized trial of adult patients to study the effects of preferential left ventricular pacing on ventriculoarterial coupling of both systemic and pulmonary circulation, indices of systolic and diastolic function of both…
- Trial name
- READAPT (NCT04420065)
- Testing
- Preferential left ventricular pacing, Biventricular pacing
- Where
- Greece
- Volunteers
- 220 people
- Sponsor
- National and Kapodistrian University of Athens
Cardiac Resynchronisation Therapy (CRT), Heart Failure
Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy
The NORDIC-CSP trial is an investigator-initiated, blinded, nordic RCT aimed at evaluating whether using direct pacing of the HIS bundle (HIS)-pacing or left bundle branch (LBB) pacing is superior to conventional biventricular…
- Conditions
- Cardiac Resynchronisation Therapy (CRT), Heart Failure, Conduction System Pacing
- Trial name
- Nordic-CSP (NCT07492979)
- Testing
- HIS or LBBB -CRT, Conventional BiV-CRT
- Where
- 5 sites in Denmark, Finland and 2 more
- Volunteers
- 1,100 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Heart Failure With Preserved Ejection Fraction (HFpEF)
ELEVATE-HFpEF Clinical Study
ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing…
- Trial name
- ELEVATE-HFpEF (NCT06678841)
- Testing
- Personalized cardiac pacing
- Where
- 51 sites in United States, Australia and 13 more
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pacing Therapy, Cardiac Pacing
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation.
- Trial name
- PSB-AF (NCT07645066)
- Testing
- RAA pacing, PSB pacing
- Where
- 10 sites in China
- Volunteers
- 300 people
- Sponsor
- Shanghai Tong Ren Hospital
Bradycardia, Syncope
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM).
- Trial name
- GENTLE-PACE (NCT05896592)
- Testing
- Invasive electrophysiological study, Extracardiac vagal stimulation, Cardioneuroablation
- Where
- 2 sites in Poland
- Volunteers
- 99 people
- Sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
Sudden Cardiac Death
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of…
- Trial name
- APPRAISE ATP (NCT02923726)
- Testing
- Arm 1 (ATP+Shock), Arm 2 (shock only)
- Where
- 134 sites in United States, Austria and 6 more
- Volunteers
- 2,692 people
- Sponsor
- Boston Scientific Corporation
Hypertrophic Cardiomyopathy
A Comparison of Two Treatments: Pacemaker and Percutaneous Transluminal Septal Ablation for Hypertrophic Cardiomyopathy
This study will compare two treatments: pacemaker implantation and percutaneous transluminal septal ablation (PTSA) for patients with hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens and obstructs…
- Trial name
- NCT00001894
- Testing
- pacemaker implantation, percutaneous transluminal septal ablation (PTSA)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Bradycardia, Cardiac Resynchronization Therapy
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- POLARIS (NCT06453850)
- Testing
- Use of FLEXIGO delivery catheter
- Where
- 17 sites in France, Germany and 3 more
- Volunteers
- 216 people
- Sponsor
- MicroPort CRM
Heart Failure, Ventricular Dysfunction
Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT).
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathy
- Trial name
- WiSE-CRT (NCT01294527)
- Testing
- Wireless cardiac stimulator implant to pace the left ventricle for CRT
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 17 people
- Sponsor
- EBR Systems, Inc.
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Heart Failure
Conduction System Pacing Optimized Therapy
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV)…
- Trial name
- CSPOT (NCT04905290)
- Testing
- Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration, Conduction System Pacing Optimized Therapy (CSPOT) configuration
- Where
- 12 sites in United States, Ireland and 2 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Heart Failure - NYHA II - IV, Left Bundle Branch Area Pacing
REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints
The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in…
- Conditions
- Heart Failure - NYHA II - IV, Left Bundle Branch Area Pacing, Left Bundle Branch Block, Intraventricular Conduction Delay
- Trial name
- RESYNC-PACE (NCT07684547)
- Testing
- Physiologic cardiac resynchronization using conduction system pacing and selective LV lead optimization.
- Where
- Hungary
- Volunteers
- 50 people
- Sponsor
- University of Pecs
First Degree Atrioventricular Block
BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study
This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction , by comparing the…
- Trial name
- REAL-CRT (NCT02150538)
- Testing
- Cardiac resynchronization therapy pacemaker, Dual chamber pacemaker
- Where
- Italy
- Volunteers
- 164 people
- Sponsor
- Gianluca Botto
Heart Failure
Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.
The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
- Trial name
- NCT05829876
- Testing
- High Frequency ECG Mapping, Q-LV Measurement
- Where
- United Kingdom
- Volunteers
- 180 people
- Sponsor
- University Hospital Birmingham
Heart Failure, Cardiomyopathy, Dilated
Role of Left Ventricular Pacing Site
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.
- Conditions
- Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
- Trial name
- NCT00221780
- Testing
- left ventricular pacing
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Bordeaux
Atrial Fibrillation, Heart Failure, Congestive
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent…
- Trial name
- NCT00262119
- Testing
- Pacemaker Medtronic EnRhythm
- Where
- Italy
- Volunteers
- 1,300 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Heart Failure
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
In this prospective, randomized, multicenter, open-label interventional clinical trial, the investigators' aim to test the effect of Cardiac Resynchronization Therapy (CRT) in cases of new-onset and persistent Left Bundle Branch…
- Trial name
- BUDAPEST-TAVI (NCT07434193)
- Testing
- CRT implantation
- Where
- Hungary
- Volunteers
- 360 people
- Sponsor
- Semmelweis University Heart and Vascular Center
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