Clinical trials: Left Bundle Branch Area Pacing
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Heart Failure
Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
The goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful. The main questions this aims to answer are: 1.
- Trial name
- EC-LBBAP (NCT05646251)
- Testing
- Heart Ultrasound
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Geisinger 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
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
Heart Failure, Systolic Bundle Branch Block, Left
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator…
- Trial name
- ACHIEVED LBBAP (NCT07526896)
- Testing
- LBBAP Therapy, LOT-CRT, ICD
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Bradycardia, Heart Failure
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant…
- Conditions
- Bradycardia, Heart Failure, Pacemaker-Induced Cardiomyopathy, Conduction Block, Atrioventricular
- Trial name
- LEAP-CAR (NCT05910866)
- Testing
- Left bundle branch area pacing (LBBAP), Right ventricular pacing (RVP)
- Where
- Italy
- Volunteers
- 130 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
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
Heart Failure With Reduced Ejection Fraction, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing in Patients With Heart Failure
The relevance of Left Bundle Branch Pacing (LBBP) lies in its potential as a promising treatment option for patients with heart failure and left bundle branch block.
- Conditions
- Heart Failure With Reduced Ejection Fraction, Left Bundle Branch Area Pacing, Heart Failure, Cardiac Resynchronization Therapy
- Trial name
- LBBAPHF (NCT06488989)
- Testing
- left bundle branch area pacing
- Where
- Kazakhstan
- Volunteers
- 50 people
- Sponsor
- National Research Center for Cardiac Surgery, Kazakhstan
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
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
Conduction System Pacing With INGEVITY+
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
- Trial name
- INSIGHT-LBBA (NCT06014866)
- Testing
- Cardiac pacing
- Where
- 8 sites in United States
- Volunteers
- 1,383 people
- Sponsor
- Duke University
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
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
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
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
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
Atrioventricular Block, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing in AVB Patients
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony.
- Trial name
- NCT03851315
- Testing
- permanent left bundle branch area pacing
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Fu Wai Hospital, Beijing, China
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