Clinical trials: Branch Block, Bundle
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
Heart Block, Aortic Stenosis
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in…
- Conditions
- Heart Block, Aortic Stenosis, Bundle-Branch Block
- Trial name
- GLUCO-TAVR (NCT06076824)
- Testing
- Methylprednisolone
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital General Universitario de Alicante
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
Cardiac Resynchronisation Therapy (CRT), Heart Failure
Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy
The NORDIC-CSP trial is an investigator-initiated, blinded, nordic RCT aimed at evaluating whether using direct pacing of the HIS bundle (HIS)-pacing or left bundle branch (LBB) pacing is superior to conventional biventricular…
- Conditions
- Cardiac Resynchronisation Therapy (CRT), Heart Failure, Conduction System Pacing
- Trial name
- Nordic-CSP (NCT07492979)
- Testing
- HIS or LBBB -CRT, Conventional BiV-CRT
- Where
- 5 sites in Denmark, Finland and 2 more
- Volunteers
- 1,100 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Heart Failure, Left Bundle-Branch Block
HIS Alternative II - UK Site
The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left…
- Trial name
- NCT05814263
- Testing
- HIS/LBB pacing, LV pacing
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Imperial College Healthcare NHS Trust
Acute Coronary Syndrome
Management of Acute Myocardial Infarction in the Presence of Left Bundle Branch Block
The primary objective of this study is to propose new treatment algorithm (strategy) for patients with Acute Coronary Syndrome (ACS) and left bundle-branch block (LBBB).
- Trial name
- NCT01494870
- Testing
- PCI
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Samara Regional Cardiology Dispensary
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, 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
Block Complete Heart, Atrial Fibrillation (AF)
Closed-Loop Stimulation in Left Bundle Branch Area Pacing
This prospective, single-center, crossover study evaluated the effects of closed-loop stimulation (CLS) compared with conventional accelerometer-based rate-adaptive pacing (VVIR) in patients with permanent atrial fibrillation…
- Conditions
- Block Complete Heart, Atrial Fibrillation (AF), Chronotropic Incompetence
- Trial name
- NCT07812935
- Testing
- Closed-Loop Stimulation, Accelerometer-Based VVIR Pacing
- Where
- Poland
- Volunteers
- 33 people
- Sponsor
- Bartlomiej Wrobel
Left Branch Bundle Block, RV - Right Ventricular Abnormality
Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)
The goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients…
- Trial name
- FOCUS-Right (NCT06601322)
- Testing
- Pacemaker Interrogation and Electrocardiogram (ECG):, Cardiopulmonary Exercise Test (CPET) and Exercise Stress Cardiac Magnetic Resonance (ExeCMR, Continuous pacemaker telemetry (CPT)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Virginia Commonwealth University
Indication for Peripheral Intravenous Catheterization, Atrial Flutter
SHERLOCK 3CG™ Diamond Tip Confirmation System
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally…
- Conditions
- Indication for Peripheral Intravenous Catheterization, Atrial Flutter, Premature Atrial Contraction, Premature Ventricular Contraction
- Trial name
- MODUS II (NCT03288766)
- Testing
- PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
- Where
- 8 sites in United States, Australia
- Volunteers
- 232 people
- Sponsor
- C. R. Bard
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
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
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
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
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.
Chagas Cardiomyopathy, Heart Failure
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to…
- Conditions
- Chagas Cardiomyopathy, Heart Failure, Systolic Dysfunction, Right Bundle Branch Block and Left Anterior Fascicular Block
- Trial name
- FIX-Chagas (NCT05519046)
- Testing
- Cardiac Contractility Modulation (CCM), CRT
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- InCor Heart Institute
Heart Failure
Triple-site Biventricular Stimulation in the Optimization of CRT
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the…
- Trial name
- TRIUMPH-CRT (NCT02350842)
- Testing
- triple-site biventricular pacing with peri-operative echo guidance, standard biventricular pacing
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
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