Clinical trials: Heart Block AV
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
Sick Sinus Syndrome, AV-Block
Left Ventricular Function and Remodelling During Permanent Pacing
1. Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure.
- Trial name
- NCT00228241
- Testing
- AAI vs. DDD vs. BIV pacing in different patients groups
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Aarhus University Hospital Skejby
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
Transcatheter Aortic Valve Implantation, Physiological Pacing
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
- PHYS-TAVI (NCT04482816)
- Testing
- Physiological pacing, Right ventricular pacing
- Where
- Spain
- Volunteers
- 24 people
- Sponsor
- Josep Lluis Mont Girbau
Atrioventricular Block
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications…
- Trial name
- SEPTAL-PM (NCT00925691)
- Testing
- RV lead
- Where
- 5 sites in France
- Volunteers
- 141 people
- Sponsor
- Rennes University Hospital
Cardiac Pacemaker, Arrhythmias, Cardiac
The Leadless AV Versus DDD Pacing Study
Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical…
- Conditions
- Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
- Trial name
- LEAVE DDD (NCT05498376)
- Testing
- Conventional pacemaker DDD, Leadless pacemaker Micra AV
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Atrioventricular Block, Second and Third Degree
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic…
- Trial name
- PACE-4-TAVI (NCT05966675)
- Testing
- conduction system pacing, right ventricular or biventricular pacing
- Where
- Poland
- Volunteers
- 500 people
- Sponsor
- Medical University of Silesia
Bradycardia; Syncope, Bradyarrhythmia
Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one.
- Conditions
- Bradycardia; Syncope, Bradyarrhythmia, Brady-tachy Syndrome, Tachycardia Bradycardia
- Trial name
- NCT04905199
- Testing
- Temporary transvenous cardiac pacing
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hunan Provincial People's Hospital
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
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
AV Block Complete, Tricuspid Regurgitation (TR)
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear.
- Trial name
- NCT06814574
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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
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
Bradyarrhythmias, AV Block Complete
Belgo-Luxembourg Leadless PM Registry
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker
- Trial name
- BELLA (NCT07879716)
- Testing
- CT scan heart, 24 hour ambulatory ECG monitoring
- Where
- 9 sites in Belgium, Luxembourg
- Volunteers
- 190 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
AV Block
Danish Randomized Trial on Leadless vs Transvenous Pacing
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block.
- Trial name
- DANVERS (NCT05856799)
- Testing
- Leadless Micra AV Transcatheter Pacing System, Transvenous Azure XT DR dual chamber pacemaker
- Where
- 2 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- University of Aarhus
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices
Vasovagal Syncope, AV Block-2Nd Degree-Type 1
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency…
- Conditions
- Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause
- Trial name
- CNA-FWRD (NCT06166277)
- Testing
- Ablation procedure
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Rush University Medical Center
Bradycardia, A-V Block
PV Loops With CNT in Multiple Pacing Sites
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV.
- Trial name
- CS-07 (NCT05345925)
- Testing
- Moderato
- Where
- Poland
- Volunteers
- 5 people
- Sponsor
- BackBeat Medical Inc
Severe Aortic Valve Stenosis, High-degree AV Block
Infranodal Conduction Time During TAVR as Predictor of HAVB
Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker…
- Conditions
- Severe Aortic Valve Stenosis, High-degree AV Block, Left Bundle-Branch Block
- Trial name
- HOM-TAVI (NCT04128384)
- Testing
- Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Hospital, Saarland
AV Block, Bundle-Branch Block
Outcomes and Safety of Various Conduction System Pacing Methods
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
- Conditions
- AV Block, Bundle-Branch Block, Atrial Fibrillation Rapid
- Trial name
- NCT04749836
- Testing
- His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing
- Where
- Slovenia
- Volunteers
- 150 people
- Sponsor
- University Medical Centre Ljubljana