Clinical Trials Logo

Cardiac Pacemaker clinical trials

View clinical trials related to Cardiac Pacemaker.

Filter by:
  • None
  • Page 1

NCT ID: NCT06100770 Recruiting - Arrhythmia Clinical Trials

Aveir AR Coverage With Evidence Development (CED) Study

ARRIVE
Start date: January 18, 2024
Phase:
Study type: Observational

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

NCT ID: NCT05935007 Recruiting - Bradycardia Clinical Trials

Aveir DR Real-World Evidence Post-Approval Study

Start date: October 31, 2023
Phase:
Study type: Observational

The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

NCT ID: NCT05932602 Recruiting - Bradycardia Clinical Trials

AVEIR DR Coverage With Evidence Development (CED) Study

Start date: October 31, 2023
Phase:
Study type: Observational

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

NCT ID: NCT05498376 Recruiting - Clinical trials for Cardiovascular Diseases

The Leadless AV Versus DDD Pacing Study

LEAVE DDD
Start date: August 23, 2022
Phase: Phase 4
Study type: Interventional

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 stimuli to the heart ("pacing"). These leads are responsible for the vast majority of morbidity after implantation and PM failures. Therefore, a leadless PM system (Micra TPS™, Medtronic, United States) has been introduced a few years ago. This system overcomes the limitations of leads, however, the first generation of the Micra TPS™ only allowed sensing and pacing in the right ventricle. More recently, an upgraded version has been introduced and gained market approval (Micra AV, Medtronic, United States). According to published results from several clinical trials, this device allows sensing the atrial activity and, thus, timing the delivery of the ventricular pacing impulse in a physiological manner similar to a conventional dual-chamber PM with two leads. Clinical feasibility and safety for this concept have been established already. However, it is unclear if this translates into a direct clinical benefit for patients in comparison to conventional PM systems. The aim of this trial is to compare the therapeutic efficacy of the Micra AV™ PM and conventional dual-chamber PM systems in patients with intermittent or permanent atrioventricular conduction block and a PM indication according to the latest European guidelines. Thus, patients will be randomized to either a conventional dual-chamber PM implantation or the implantation of a leadless Micra AV™ system. Patients will be stratified for gender (female/male) and a priori estimated physical exercise capacity ("fit"/"unfit"). The primary outcome will be the physical exercise capacity of the patients. The null hypothesis with regards to the primary endpoint is that the leadless pacemaker arm shows an inferior VO2 anaerobic threshold than the conventional pacemaker arm. Hence the alternative hypothesis postulates that the leadless pacemaker arm shows a non-inferior VO2 anaerobic threshold compared to the conventional pacemaker arm. Rejection of the null hypothesis is needed to conclude non-inferiority.

NCT ID: NCT05336877 Recruiting - Bradycardia Clinical Trials

Aveir VR Coverage With Evidence Development Post-Approval Study

CED
Start date: June 21, 2022
Phase:
Study type: Observational

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

NCT ID: NCT02195024 Terminated - Clinical trials for Magnetic Resonance Imaging

Cardiac MRI After Pacemaker Replacement

MRI-rePACE
Start date: July 2014
Phase: Phase 4
Study type: Interventional

Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI) in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker system, to assess MR-image quality and to prove the safety of MRI in this specific population in the short term as well as during long term follow-up.