Clinical trials: Left Bundle Branch Pacing, open to volunteers
AV Block
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block.
- Trial name
- STAY II (NCT06707662)
- Testing
- Pacemaker and defibrillator
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Parc de Salut Mar
Heart Failure, Heart Failure With Reduced Ejection Fraction
Left vs Left Randomized Clinical Trial
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality)…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block, LBBB
- Trial name
- NCT05650658
- Testing
- His/LBBP, BiVP
- Where
- 71 sites in United States, Canada
- Volunteers
- 2,136 people
- Sponsor
- Baylor College of Medicine
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
Patients with new-onset complete LBBB (QRS > 120 ms, persisting > 24 h after TAVI) and moderately reduced LVEF (35-50%) will be screened in participating centers.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block, Reduced Left Ventricular Ejection Fraction
- Trial name
- LBB(AP)TAVI (NCT07909239)
- Testing
- Left bundle branch area pacing with pacemaker, Implantation loop recorder
- Where
- France
- Volunteers
- 700 people
- Sponsor
- University Hospital, Clermont-Ferrand
Heart Failure and Reduced Ejection Fraction, Dyssynchrony
Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure
The goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat…
- Trial name
- RIPCORD-CRT (NCT07430553)
- Testing
- Biventricular pacing, Conduction system pacing, Left bundle optimised cardiac resynchronisation therapy
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London
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
Cardiac Resynchronization Therapy, Heart Failure
Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant
Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial).
- Trial name
- CONSYST-CRT II (NCT06105580)
- Testing
- Conduction system pacing, Biventricular pacing
- Where
- Spain
- Volunteers
- 320 people
- Sponsor
- Hospital Clinic of Barcelona
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
AI-Guided Left Bundle Branch Area Pacing
The purpose of this study is to compare the effectiveness of AI-guided LBBAP versus conventional LBBAP (not AI-guided) in improving CRT response rates and clinical outcomes.
- Trial name
- NCT07206602
- Testing
- AI-assisted Left Bundle Branch Area Pacing, Left Bundle Branch Area Pacing
- Where
- United States
- Volunteers
- 224 people
- Sponsor
- Mayo Clinic
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, 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
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 - 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
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
Heart Failure, Block, Heart
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or…
- Conditions
- Heart Failure, Block, Heart, Pacing-Induced Cardiomyopathy
- Trial name
- NCT06620705
- Testing
- Left bundle branch area pacing, Biventricular pacing
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 34 people
- Sponsor
- srdpiers
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
Left Bundle Branch Block, Left Bundle Branch Area Pacing
UHF ECG in LBBB and Response to CRT Prediction
The main objective of the project is to demonstrate that in patients with heart failure and QRS complex of nonRBBB morphology lasting over 130 ms, UHF-ECG can differentiate patients with trueLBBB from IVCD better than existing…
- Conditions
- Left Bundle Branch Block, Left Bundle Branch Area Pacing, Biventricular Pacing, Intraventricular Conduction Delay
- Trial name
- UHF BLOCK (NCT07057544)
- Testing
- LBBAP CRT device implantation, BVP-CRT
- Where
- Czechia
- Volunteers
- 200 people
- Sponsor
- Faculty Hospital Kralovske Vinohrady
Heart Failure, Left Bundle Branch Block
Clinical Efficacy and Safety of Left Bundle Branch Area Pacing Using Quantitative Guidance of Multimodal Data in the Treatment of Heart Failure
Heart failure is a common chronic cardiovascular disease that seriously impairs patients' quality of life and long-term prognosis.
- Conditions
- Heart Failure, Left Bundle Branch Block, Non-ischemic Cardiomyopathy
- Trial name
- NCT07814612
- Testing
- Apply multimodal data fusion for quantitative guidance of left bundle branch region pacing, Conventional Biventricular Pacing
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital of Nanchang 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
Bradycardia, Conduction Block, Atrioventricular
LLL vs. SDL for LBBP: A Non-inferiority RCT
Left Bundle Branch Pacing (LBBP) has emerged as one of the most commonly used physiological pacing modalities in clinical practice.
- Trial name
- NCT07378124
- Testing
- SDL implantation, LLL implantation
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Ningbo No.2 Hospital
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