Clinical trials: Left Bundle-Branch Pacing
Permanent His Bundle Pacing, Permanent Left Bundle Branch Pacing
Safety and Efficacy of His Bundle Pacing Validated by Extracardiac Vagal Nerve Stimulation
Different studies for extracardiac vagal nerve stimulation (ECANS) have been published and confirmed the influence of the vagus nerve on automaticity and conduction properties of the sinus node, atria, atrioventricular node, as…
- Trial name
- HIS-STORY (NCT04816864)
- Testing
- extracardiac vagal nerve stimulation (ECANS) + EPS
- Where
- 3 sites in Poland
- Volunteers
- 60 people
- Sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
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
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
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, 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
Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a…
- Trial name
- CSP Display (NCT07733960)
- Testing
- CSP Display research system
- Where
- 2 sites in India
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Left Bundle-Branch Block
LV Only MPP With SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy…
- Trial name
- NCT03567096
- Testing
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Conduction Block, Atrioventricular, Bundle-Branch Block
Novel Approach to Conduction System Pacing With Use of Ultrasound
Each year, over one million pacemakers are implanted globally using x-rays. Recent developments have been aimed at determining which area of the heart is the best option for lead placement.
- Trial name
- CONDUCT USe (NCT06815783)
- Testing
- Ultrasound guidance, Fluoroscopy guided
- Where
- 2 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Habib Khan
Atrial Fibrillation
The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation
Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing
- Trial name
- LAP-TOP (NCT05449158)
- Testing
- left atrial pressure regulation
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Shanghai 10th People's Hospital
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
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
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
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Cardiac Pacing, Pacing Therapy
Image Location and Performance of Left Bundle Branch Pacing
This is a prospective, multi-site, non-randomized, data collection study. The purpose of this study is to investigate the correlation between pacing sites and ECG morphology or pacing parameters during left bundle branch pacing…
- Trial name
- NCT04119323
- Where
- 3 sites in China
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
Left Bundle-Branch Pacing
STylet-driven vs. LumenlEss Lead in Left-Bundle-Branch Pacing
The STYLE-LBBP study aims to compare the efficacy and safety of left-bundle branch pacing between the two types of available pacing leads: lumenless vs stylet-driven.
- Trial name
- STYLE-LBBP (NCT06049992)
- Testing
- Pacemaker implantation with conduction system pacing using Lumenless leads, Pacemaker implantation with conduction system pacing using Stylet-driven leads
- Where
- 2 sites in Spain
- Volunteers
- 120 people
- Sponsor
- Puerta de Hierro University Hospital
Atrioventricular Block, Left Bunde Branch Area Pacing
Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction
Conventional right ventricular pacing (RVP) has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes.
- Conditions
- Atrioventricular Block, Left Bunde Branch Area Pacing, Conduction System Pacing
- Trial name
- NOVEL II (NCT07464041)
- Testing
- Left Bundle Branch Area Pacing, Right venticular pacing
- Where
- 4 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Samsung Medical Center
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
Ventricular Tachycardia (VT), Ventricular Fibrillation
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients.
- Trial name
- NCT06745778
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure