Clinical trials: Left Bundle Branch Pacing
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
Pacemaker DDD, His Bundle Pacing
Pacing to Maintain Physiologic Ventricular Activation
Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest…
- Conditions
- Pacemaker DDD, His Bundle Pacing, LBB Area Pacing, Pacing-Induced Cardiomyopathy
- Trial name
- Pace-Conduct (NCT04416958)
- Testing
- cardiac implantable electronic device (CIED) implantation
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Klinikum-Fuerth
Bradycardia, Atrioventricular Block
BIOTRONIK Conduction System Pacing With the Solia Lead
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area.
- Conditions
- Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies
- Trial name
- BIO-CONDUCT (NCT05251363)
- Testing
- Solia S lead
- Where
- 14 sites in United States
- Volunteers
- 194 people
- Sponsor
- Biotronik, Inc.
Heart Failure, Left Bundle-Branch Block
Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure
The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.
- Conditions
- Heart Failure, Left Bundle-Branch Block, Cardiac Resynchronization, Conduction System Pacing
- Trial name
- PhysioSync-HF (NCT05572736)
- Testing
- Conduction system pacing, Biventricular pacing
- Where
- 14 sites in Brazil
- Volunteers
- 179 people
- Sponsor
- Hospital Moinhos de Vento
Atrioventricular Block, Left Bunde Branch Area Pacing
Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction
Conventional right ventricular pacing (RVP) has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes.
- Conditions
- Atrioventricular Block, Left Bunde Branch Area Pacing, Conduction System Pacing
- Trial name
- NOVEL II (NCT07464041)
- Testing
- Left Bundle Branch Area Pacing, Right venticular pacing
- Where
- 4 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Samsung Medical Center
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
Left Bundle-Branch Pacing
STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing
The STYLE-LBBP study aims to compare the efficacy and safety of left-bundle branch pacing between the two types of available pacing leads: lumenless vs stylet-driven.
- Trial name
- STYLE-LBBP (NCT06049992)
- Testing
- Pacemaker implantation with conduction system pacing using Lumenless leads, Pacemaker implantation with conduction system pacing using Stylet-driven leads
- Where
- 2 sites in Spain
- Volunteers
- 120 people
- Sponsor
- Puerta de Hierro University Hospital
Heart Failure, Left Bundle-Branch Block
Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and…
- Trial name
- MAP HIS HF (NCT03803995)
- Testing
- Mapping and Pacing the His Bundle, Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Left Bundle-Branch Block
Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.
The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left…
- Trial name
- HIS-alt_2 (NCT04409119)
- Testing
- HIS/LBB pacing, LV pacing
- Where
- Denmark
- Volunteers
- 150 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Atrioventricular Block, Cardiac Surgery
OPTImizing Lead Placement in Patients Requiring Pacemaker After Cardiac Surgery
Conventional right ventricular pacing has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes.
- Trial name
- OPTI-PACS (NCT07795541)
- Testing
- Left bundle branch area pacing, Conventional pacing strategy
- Volunteers
- 110 people
- Sponsor
- Sahlgrenska University Hospital
Atrial Fibrillation (AF), Pacemaker Therapy
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate…
- Conditions
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block, Preserved Ejection Fraction
- Trial name
- LBBP-AHRE (NCT07250529)
- Testing
- Right Ventricular Pacing, Left Bundle Branch Pacing
- Where
- Greece
- Volunteers
- 244 people
- Sponsor
- University Hospital of Patras
Symptomatic Bradycardia
Pacing Characteristics of a Conventional Bipolar
Study Title: Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia Study Objectives: To characterize an approach for left bundle…
- Trial name
- NCT06011252
- Testing
- Solia S lead with any BIOTRONIK Pacemaker
- Where
- 5 sites in Taiwan
- Volunteers
- 134 people
- Sponsor
- Chang Gung Memorial Hospital
Heart Failure, CRT and/or ICD
Evaluation of Electrical and Hemodynamic Effects of Different Pacing Strategies in CRT Candidates
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients.
- Trial name
- NCT07032064
- Testing
- Sequential ventricular pacing at five sites
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Shanghai Zhongshan Hospital
Left Ventricular Ejection Fraction Less Then or Equal to 50percent
Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics.
- Trial name
- NCT06148571
- Testing
- left bundle branch area pacing
- Where
- South Korea
- Volunteers
- 142 people
- Sponsor
- Seoul National University Hospital
Cardiac Pacing
Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum
Conduction system pacing (CSP), including His bundle pacing (HBP) and left bundle branch (LBB) pacing (LBBP), as a physiological pacing strategy, can achieve interventricular and/or intra-left ventricular mechanical…
- Trial name
- NCT05557006
- Testing
- left bundle branch pacing
- Where
- China
- Volunteers
- 50 people
- Sponsor
- General Hospital of Shenyang Military Region
Chronic Heart Failure
Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy
The present study will recruit 40 symptomatic heart failure patients with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch block(QRSd≥130 ms).
- Trial name
- LBBP-RESYNC (NCT04110431)
- Testing
- Left bundle branch pacing, Biventricular pacing
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Left Bundle Branch Area Pacing
Transesophageal Echocardiography in Conductive System Pacing in Pediatric Patients
The investigatorse will use the guidance of Intraprocedural three-dimensional transesophageal echocardiography (3D-TEE) for Left Bundle Branch Area Pacing (LBBAP) lead implantation in pediatric patients.
- Trial name
- NCT07882563
- Testing
- Left Bundle Branch Pacing
- Volunteers
- 56 people
- Sponsor
- Assiut University
Atrioventricular Block
Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block
OptimPacing study has been designed as a prospective, multi-center, randomized, controlled trial. A total of 11 medical centers across China will enroll 683 patients over an estimated recruitment period of 2 years.
- Trial name
- OptimPacing (NCT04624763)
- Testing
- Left bundle branch pacing, Right ventricular pacing
- Where
- China
- Volunteers
- 683 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
The recent development and market introduction of small diameter implantable defibrillation leads able to deliver left bundle branch area pacing (LBBAP) has opened the possibility of achieving cardiac resynchronization therapy…
- Trial name
- FORGE CSP (NCT07406737)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Caen