Clinical trials: Left Bundle-Branch Pacing, open to volunteers
Heart Failure
Clinical Prospective ranDomized Trial to Evaluate the Non-inferiority of Left Bundle Branch Area Pacing Vs Cardiac ResynchronIzatioN Therapy With ECG guIded AV Optimization
Cardiac resynchronization therapy is the gold standard therapy for patients with advanced HF left ventricle dysfunction and large QRS.
- Trial name
- DA VINCI (NCT07107048)
- Testing
- Pacemaker and defibrillator
- Where
- Italy
- Volunteers
- 194 people
- Sponsor
- Leonardo Calò, MD
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
Heart Failure, Intraventricular Block
A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
BATTLE study has been designed as a prospective, multi-center, randomized, controlled trial. This study will enroll 83 patients with chronic heart failure accompanied by intraventricular block (NICD) over an estimated recruitment…
- Trial name
- BATTLE (NCT06061627)
- Testing
- LOT-CRT group, BiVP group
- Where
- China
- Volunteers
- 86 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Atrial Fibrillation (AF)
Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial…
- Trial name
- PALLIATE-AF (NCT06699342)
- Testing
- Pacemaker implantation with Left bundle branch area pacing (LBBAP), Atrioventricular node ablation (AVNA), Pharmacologic therapy optimized for Atrial Fibrillation management
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Seoul National University Hospital
Permanent Atrial Fibrillation, Preserved Ejection Fraction
Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial
The goal of this clinical trial is to learn whether left bundle branch area pacing, a technique designed to activate the heart's natural electrical conduction system, is better than conventional right ventricular pacing in adults…
- Trial name
- BEAT (NCT07759700)
- Testing
- LBBA pacing, Conventional pacing
- Where
- France
- Volunteers
- 642 people
- Sponsor
- Poitiers University Hospital
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, 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
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
Right Heart Failure
Accelerated LBBP for Patients With RHF and Severe TR
This study is a prospective, single-arm, target value clinical trial. We plan to prospectively enroll and follow 24 patients across three centers nationwide who have a low baseline heart rate (HR ≤ 60 bpm), meet the indication…
- Trial name
- ARCP (NCT07470047)
- Testing
- permanent pacemaker implantation
- Where
- 3 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai Zhongshan Hospital
Arrhythmias, Cardiac, Atrioventricular Block
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical…
- Conditions
- Arrhythmias, Cardiac, Atrioventricular Block, Reduced Systolic Function, Atrial Fibrillation
- Trial name
- TREEBEARD (NCT06324682)
- Testing
- Cardiac pacing - Conventional RV pacing, Cardiac pacing - Conduction System Pacing, Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
- Where
- 31 sites in Italy
- Volunteers
- 8,400 people
- Sponsor
- University Hospital of Ferrara
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
Atrial Fibrillation (AF), Heart Failure
LBBAP vs. CS Pacing for CRT in Permanent Atrial Fibrillation and Heart Failure (SYNC-AF)
This is a prospective, multicenter, randomized controlled trial comparing Left Bundle Branch Area Pacing (LBBAP)-based cardiac resynchronization therapy (CRT) with conventional coronary sinus (CS) lead-based CRT in patients with…
- Conditions
- Atrial Fibrillation (AF), Heart Failure, Cardiomyopathies
- Trial name
- SYNC-AF (NCT07560891)
- Testing
- Left Bundle Branch Area Pacing (LBBAP) for CRT, Coronary Sinus (CS) Lead-Based Biventricular CRT
- Volunteers
- 44 people
- Sponsor
- Yonsei University
Left Bundle-Branch Block, Pacemaker DDD
Left Bundle Branch Area Mapping for Conduction System Pacing
This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area.
- Trial name
- NCT05884359
- Testing
- 3D Electroanatomical Mapping (NavX)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
Atrial Fibrillation, Sick Sinus Syndrome
PACE-AF: Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation
PACE-AF is a prospective, observational patient registry designed to evaluate the impact of pacemaker algorithms on atrial fibrillation (AF) incidence, progression, and clinical outcomes in patients implanted with dual-chamber…
- Conditions
- Atrial Fibrillation, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- PACE-AF (NCT07279207)
- Where
- Russia
- Volunteers
- 500 people
- Sponsor
- Ilya Lukin
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
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
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
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
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
Atrioventricular Block, Pacemaker
Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021.
- Trial name
- LBAP-TAVI (NCT07236489)
- Testing
- Pacemaker implantation using left bundle branch area stimulation, Right ventricular pacemaker implantation
- Where
- 7 sites in France
- Volunteers
- 266 people
- Sponsor
- Nantes University Hospital