Last reviewed · How we verify
NCT05336877: CED
Aveir VR Coverage With Evidence Development Post-Approval Study
trial testing Aveir VR Leadless Pacemaker System in Cardiac Pacemaker in 8,744 participants. Currently enrolling.
1 January 2028
Quick facts
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 8,744 |
| Start date | 21 June 2022 |
| Primary completion | 1 January 2028 |
| Estimated completion | 1 January 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aveir VR Leadless Pacemaker System
- Single-Chamber Transvenous Pacemaker
Conditions studied
- Cardiac Pacemaker — all drugs for Cardiac Pacemaker →
- Arrythmia — all drugs for Arrythmia →
- Bradycardia — all drugs for Bradycardia →
Sponsor
Abbott Medical Devices — full company profile →
Who can join
18 and older, any sex, with Cardiac Pacemaker or Arrythmia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Leadless Versus Transvenous Single-Chamber Ventricular Pacemakers: Real-World Evidence From Aveir VR Coverage With Evidence Development Study.
Ip JE, Brady PA, Kroman AM, Mondésert B, et al · · 2025 · PMID 41128279 · DOI 10.1161/jaha.125.042471 -
Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data.
Mullane S, Hicks JB, Sharmin K, Harrell C, et al · · 2024 · PMID 39720009 · DOI 10.2147/por.s499248
Verify or expand the search:
- PubMed search for NCT05336877
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aveir VR Leadless Pacemaker System
Trials testing the same drug.
- NCT05270499 — Aveir VR Real-World Evidence Post-Approval Study · recruiting
- NCT04559945 — The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System · NA · active not recruiting
Other recruiting trials for Cardiac Pacemaker
Currently open trials in the same condition.
- NCT05498376 — The Leadless AV Versus DDD Pacing Study · Phase 4 · recruiting
- NCT05270499 — Aveir VR Real-World Evidence Post-Approval Study · recruiting
Other Abbott Medical Devices trials
Trials by the same sponsor.
- NCT07421076 — Grid eXplore Mapping Study · NA · recruiting
- NCT07509658 — TriClip Japan Post-Approval Study · recruiting
- NCT07361445 — Agilis RF TSP Early Feasibility Study · NA · recruiting
- NCT07373353 — A Clinical Evaluation of AMJ-401 · NA · recruiting
- NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05336877 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
- Last refreshed: 31 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05336877.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing