Clinical trials: Left Bundle-Branch Block, open to volunteers
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
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
Prediction of Outcome by Echocardiography in Left Bundle Branch Block
Patients with left bundle branch block have an increased risk for the development of heart-failure and death. However, risk factors for unfavorable outcomes are still poorly defined.
- Trial name
- EchoLBBB (NCT04293471)
- Where
- Norway
- Volunteers
- 2,000 people
- Sponsor
- University Hospital of North Norway
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
Aortic Valve Disease, Conduction Disturbances
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
The purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (NOP-LBBB)…
- Trial name
- MARE (NCT02153307)
- Testing
- Implantable loop recorders system Reveal ICM LINQ®,
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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
Heart Failure With Reduced Ejection Fraction
Improving CRT Outcome With Non-Invasive Cardiac Mapping
The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement.
- Trial name
- ICONIC-M (NCT05564793)
- Testing
- Pre-implantation planning, Post-implantation assessment
- Where
- 11 sites in Netherlands, Portugal and 2 more
- Volunteers
- 330 people
- Sponsor
- EP Solutions SA
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
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
Sinus Node Disease, Atrioventricular Block
BIO|STREAM.CSP CLS
This clinical study is a prospective, observational submodule of the BIO|STREAM.CSP registry designed to evaluate clinical outcomes in patients receiving BIOTRONIK dual-chamber pacemakers that combine conduction system…
- Trial name
- NCT07608822
- Testing
- Left bundle branch area pacing with Closed Loop Stimulation
- Where
- 12 sites in Czechia, Hungary and 3 more
- Volunteers
- 150 people
- Sponsor
- Biotronik SE & Co. KG
Acute Myocardial Infarction (AMI), Left Bundle Branch Block
Machine Learning for Diagnosis of Occlusive MI in LBBB Patients
This study investigates a new way to diagnose severe heart attacks in patients who have a specific electrical heart pattern called a Left Bundle Branch Block (LBBB).
- Conditions
- Acute Myocardial Infarction (AMI), Left Bundle Branch Block, Coronary Occlusion/Thrombosis, Chest Pain
- Trial name
- AI-LBBB (NCT07620119)
- Testing
- Digital 12-Lead ECG Analysis and Invasive Coronary Angiography
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Konya City Hospital
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 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
Left Bundle Branch Block (LBBB) on ECG
Clinical Observational Registry of Patients With Left Bundle Branch Block
The electromechanical dyssynchrony induced by the presence of LBBB is in some patients, but not all, the cause of progressive left ventricular systolic dysfunction and heart failure. Aims 1.
- Trial name
- RECOrd-LBBB (NCT05283603)
- Testing
- ECG, Echocardiogram, Magnetic resonance
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Azienda Ospedaliero Universitaria di Sassari
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients.
- Conditions
- Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
- Trial name
- PROMOTE (NCT04139616)
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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
Sick Sinus Syndrome, Atrioventricular Nodal Dysfunction
Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval
The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and…
- Trial name
- CLOSE-AV (NCT07314008)
- Testing
- LBBAP, MVP
- Where
- South Korea
- Volunteers
- 440 people
- Sponsor
- Asan Medical Center
Left Bundle-Branch Block, Aortic Valve Stenosis
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization…
- Trial name
- COME-TAVI (NCT03303612)
- Testing
- Pacemaker implant, Transcutaneous cardiac monitor
- Where
- 10 sites in Canada, France
- Volunteers
- 250 people
- Sponsor
- Montreal Heart Institute
Heart Failure, Left Bundle-Branch Block
Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders
Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with the increased mortality, more frequent…
- Conditions
- Heart Failure, Left Bundle-Branch Block, Ischemic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy
- Trial name
- RESCUE (NCT05760924)
- Testing
- Cardiac Resynchronization Therapy Devices with Defibrillator Function (CRT-D) or CRT-D Leads Replacement, CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right and Left Ventricular Pacing, CRT-D or CRT-D Leads Replacement with New Lead Implantation to Left Bundle Branch and Inactivation of Conventional Right Ventricular Pacing
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences