Clinical trials: Left Bundle-Branch Pacing
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
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
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
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
Bradycardia, Left Bundle Branch Area Pacing
Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- STARLIGHT (NCT07342608)
- Testing
- Use of LINEA cardiac pacing lead
- Where
- 14 sites in Belgium, France and 3 more
- Volunteers
- 450 people
- Sponsor
- MicroPort CRM
Left Bundle Branch Area Pacing, Right Ventricular Pacing
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in…
- Conditions
- Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block, Atrial Fibrillation
- Trial name
- NCT06023784
- Testing
- left bundle branch area pacing, right ventricular pacing
- Where
- China
- Volunteers
- 530 people
- Sponsor
- Peking Union Medical College Hospital
Left Bundle Branch Area Pacing
CSP-SOLIA-REGISTRY
The CSP Registry is a prospective, multicenter, observational, real-world study designed to evaluate the acute feasibility and long-term performance of the Solia CSP lead in Brazilian patients with a clinical indication for…
- Trial name
- NCT07808554
- Testing
- Solia CSP S Lead
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Hospital SOS Cardio
Bradycardia, Atrioventricular Block
Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture
This is a prospective, multicenter, randomized controlled trial designed to determine whether direct capture of the left ventricular conduction system must be achieved as the procedural endpoint of left bundle branch area pacing…
- Conditions
- Bradycardia, Atrioventricular Block, Sick Sinus Syndrome, Cardiac Pacing
- Trial name
- COMPARE-SYNC (NCT07804394)
- Testing
- LBBAP with mandatory left ventricular conduction system capture (LBBP or LFP), LBBAP with left ventricular septal capture as the accepted procedural endpoint (LVSP)
- Volunteers
- 300 people
- Sponsor
- Yonsei University
Bradycardia, Pacing
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates.
- Conditions
- Bradycardia, Pacing, Right Ventricular Pacing, His Bundle Pacing
- Trial name
- PROTECT-HF (NCT05815745)
- Testing
- Pacemaker - Physiological pacing, Pacemaker - Right Ventricular pacing
- Where
- 45 sites in Ireland, Slovenia and 1 more
- Volunteers
- 2,600 people
- Sponsor
- Imperial College London
Left Bundle Branch Area Pacing
The Boston Pace Study
Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction.
- Trial name
- NCT05869500
- Testing
- Left Bundle Branch Area Pacemaker, Right Ventricular Pacemaker
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
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
Heart Failure, Left Bundle Branch Pacing
Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy
This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical…
- Trial name
- Early-RESYNC (NCT06126081)
- Testing
- LBBP+GDMT, GDMT
- Where
- 2 sites in China
- Volunteers
- 36 people
- Sponsor
- Fu Wai Hospital, Beijing, China
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
HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death
Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy
Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the…
- Conditions
- HCM - Hypertrophic Cardiomyopathy, Sudden Cardiac Death, Left Bundle Branch Pacing, ICD
- Trial name
- LEFTpaceHCM (NCT07372196)
- Testing
- ICD with left bundle branch area pacing (LBBAP), dual-chamber ICD
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Tricuspid Valve Regurgitation, Pacemaker
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead.
- Conditions
- Tricuspid Valve Regurgitation, Pacemaker, ICD, Left Bundle Branch Area Pacing
- Trial name
- LITR (NCT07342036)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Hazem Omran
Bradyarrhythmia, Atrioventricular Block
PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial
PROTECT-SYNC study is a multicenter, randomized, controlled trial. A total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period.
- Conditions
- Bradyarrhythmia, Atrioventricular Block, Left Bundle Branch Area Pacing
- Trial name
- NCT05585411
- Testing
- Left bundle branch area pacing, Right ventricular pacing
- Where
- 8 sites in South Korea
- Volunteers
- 450 people
- Sponsor
- Yonsei University
Atrioventricular Block, Left Bundle Branch Area Pacing
Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)
This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular…
- Conditions
- Atrioventricular Block, Left Bundle Branch Area Pacing, Right Ventricular Pacing, Heart Failure
- Trial name
- LEAP-Block (NCT04730921)
- Testing
- Left bundle branch area pacing, Right ventricular pacing
- Where
- 8 sites in China
- Volunteers
- 486 people
- Sponsor
- Fu Wai Hospital, Beijing, China
Atrial Arrhythmia, Atrial Fibrillation (AF)
Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.
This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation (AF), Pacemaker Implantation, Left Bundle Branch Pacing
- Trial name
- AHRE-BLAST (NCT07305194)
- Where
- Greece
- Volunteers
- 460 people
- Sponsor
- University Hospital of Patras
Bradycardia, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead…
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Cardiac Resynchronisation Therapy (CRT), ECG
- Trial name
- LBBOT (NCT07254013)
- Testing
- LBBAP implant
- Where
- 4 sites in France
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Atrial Fibrillation (AF), AV Node Ablation
REDO-AF: Randomized Evaluation of Dual Options for AF Re-intervention
The goal of this randomized open-label clinical trial is to evaluate two different strategies for the treatment of recurrent atrial fibrillation (AF) after AF ablation.
- Conditions
- Atrial Fibrillation (AF), AV Node Ablation, Left Bundle Branch Pacing
- Trial name
- REDO-AF (NCT07245147)
- Testing
- Redo AF Ablation, Pace and Ablate
- Where
- Canada
- Volunteers
- 16 people
- Sponsor
- Jacqueline Joza