Clinical Trials Logo

Clinical Trial Summary

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 Aveirâ„¢ AR LP system).


Clinical Trial Description

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir AR LP health outcomes among Medicare beneficiaries. The study will enroll all Medicare patients with continuous claims data implanted with the Aveir AR LP or a single-chamber atrial transvenous pacemaker system from any manufacturer. Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06100770
Study type Observational
Source Abbott Medical Devices
Contact Nicole Harbert
Phone 972-526-4841
Email nicole.harbert@abbott.com
Status Recruiting
Phase
Start date January 18, 2024
Completion date January 2031

See also
  Status Clinical Trial Phase
Recruiting NCT05048602 - Drug-induced Brugada Syndrome Research Database
Completed NCT05053243 - Clinical Validation of the AliveCor Kardia 12L and 6L Devices N/A
Completed NCT01913561 - The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection N/A
Completed NCT01688648 - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft N/A
Completed NCT01396226 - A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients Phase 2
Terminated NCT00624520 - Mental Stress Reduction in Defibrillator Patients Phase 3
Completed NCT00756886 - Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study N/A
Terminated NCT00721149 - NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study Phase 3
Completed NCT00510029 - Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously Phase 1
Completed NCT00578617 - Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial N/A
Active, not recruiting NCT00135174 - Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study N/A
Completed NCT00119847 - Electrophysiological Effects of Late PCI After MI N/A
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Completed NCT00035490 - Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators Phase 3
Completed NCT00004560 - Public Access Defibrillation (PAD) Community Trial Phase 3
Completed NCT01076361 - Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study N/A
Recruiting NCT00138931 - Genetics of Cardiovascular and Neuromuscular Disease
Completed NCT00622453 - Arrhythmias in Myotonic Muscular Dystrophy N/A
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT00000531 - Antiarrhythmics Versus Implantable Defibrillators (AVID) Phase 3