Clinical trials: Atrioventricular Heart-block
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Atrioventricular Nodal Disease
Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block
Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term.
- Trial name
- NCT05129098
- Testing
- Left bundle branch pacing lead (Select Secure 3830 lead), Right ventricular active fixation lead
- Where
- Greece
- Volunteers
- 38 people
- Sponsor
- University Hospital of Patras
Atrioventricular Block
Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
The TELE-SPACER study is a multicenter, noncommercial, physician-initiated, proof-of-concept, prospective, randomized, controlled, unblinded clinical trial and registry designed to compare two methods of treatment of patients…
- Trial name
- TELE-SPACER (NCT05774262)
- Testing
- Pacemaker implantation, Cardioneuroablation (CNA)
- Where
- 2 sites in Poland
- Volunteers
- 300 people
- Sponsor
- American Heart of Poland
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
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
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, AV Block
Synchrony in Cardiac Conduction: Assessing the Effects of Pacing on Cardiac Performance Through Magnetic Resonance Imaging and Advanced ECG-imaging
Rationale Right ventricular pacing (RVP) is an established and effective therapy for patients with atrioventricular (AV) block. However, frequent RVP has been associated with left ventricular (LV) dyssynchrony and may progess…
- Trial name
- HARMONY (NCT06843135)
- Testing
- Ventricular pacing
- Volunteers
- 88 people
- Sponsor
- Amsterdam UMC, location VUmc
Transcatheter Aortic Valve Implantation, Physiological Pacing
Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined…
- Conditions
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block
- Trial name
- PHYSTAVIII (NCT06197503)
- Testing
- Conduction system pacing, Right ventricular pacing
- Where
- Spain
- Volunteers
- 48 people
- Sponsor
- Hospital Clinic of Barcelona
Atrial Fibrillation (AF), Pacemaker Therapy
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate…
- Conditions
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block, Preserved Ejection Fraction
- Trial name
- LBBP-AHRE (NCT07250529)
- Testing
- Right Ventricular Pacing, Left Bundle Branch Pacing
- Where
- Greece
- Volunteers
- 244 people
- Sponsor
- University Hospital of Patras
Coronary Artery Spasm, Hypertension
The Prevalence of Coronary Spasm in Hypertensive Patients Treated With Antihypertensive Medication
Autonomic nerve function is involved in both blood pressure (BP) regulation and the pathogenesis of coronary artery spasm(CAS), but few studies have been published about the relationship between CAS and effect of BP lowering…
- Trial name
- NCT01882790
- Where
- 3 sites in South Korea
- Volunteers
- 1,933 people
- Sponsor
- Korea University
Sinus Node Dysfunction, Heart Block AV
The Fluoroless-CSP Trial Using Electroanatomic Mapping
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster…
- Conditions
- Sinus Node Dysfunction, Heart Block AV, LBBB, Heart Failure, Systolic
- Trial name
- NCT03903107
- Testing
- Conventional fluoroscopy guided Conduction System Pacing(CSP), Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Rush University Medical Center
Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity.
- Conditions
- Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block, Postoperative Complete Heart Block
- Trial name
- NCT01477658
- Where
- Brazil
- Volunteers
- 140 people
- Sponsor
- University of Sao Paulo
Sinus Node Disease., First Degree Atrioventricular Block.
Minimizing Ventricular Pacing
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality…
- Trial name
- NCT01611389
- Testing
- Prolonging atrioventricular (AV) delay., Standard atrioventricular (AV) delay.
- Where
- Poland
- Volunteers
- 60 people
- Sponsor
- Military Institute od Medicine National Research Institute
Bradycardia, Heart Block
Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers
This study is a prospective, single-arm, single-center feasibility study evaluating the safety and feasibility of transjugular (internal jugular vein) implantation of the Aveir VR leadless ventricular pacemaker in patients…
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- NCT07802119
- Testing
- Aveir VR Leadless Pacemaker
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Min Shen
Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular…
- Conditions
- Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy, Heart Failure
- Trial name
- STAY (NCT06026683)
- Testing
- Pacemaker implant
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Parc de Salut Mar
Atrio-Ventricular Block
Efficacy and Safety of Left Bundle Area Pacing Vs Right Ventricular Apical Pacing in Patients with Atrioventricular Block
This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy
- Trial name
- NCT06674967
- Where
- Egypt
- Volunteers
- 42 people
- Sponsor
- Assiut University
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
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
Bradycardia Sinus, AV Block
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Trial name
- NCT06910059
- Testing
- Observational
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sinus Node Dysfunction, Brady Tachy Syndrome
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
- Trial name
- NCT01170611
- Testing
- PACEMAKER SYMPHONY 2550
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 400 people
- Sponsor
- LivaNova