Last reviewed · How we verify
NCT04349995: PFO PMS Jpn
Amplatzer PFO Occluder Post-marketing Surveillance Study
trial testing Amplatzer PFO Occluder in PFO - Patent Foramen Ovale in 500 participants. Participants enrolled and being followed up; not accepting new ones.
14 December 2022
Quick facts
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 October 2019 |
| Primary completion | 14 December 2022 |
| Estimated completion | 28 May 2026 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Amplatzer PFO Occluder
Conditions studied
- PFO - Patent Foramen Ovale — all drugs for PFO - Patent Foramen Ovale →
Sponsor
Abbott Medical Devices — full company profile →
Who can join
Eligibility, any sex, with PFO - Patent Foramen Ovale. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04349995
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Amplatzer PFO Occluder
Trials testing the same drug.
- NCT04339699 — NobleStitch EL STITCH Trial is a PFO Comparative Trial · NA · recruiting
Other recruiting trials for PFO - Patent Foramen Ovale
Currently open trials in the same condition.
- NCT07414446 — Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device · NA · recruiting
- NCT06203873 — A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine · NA · recruiting
- NCT04946734 — Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine · Phase 3 · active not 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 NCT04349995 (US National Library of Medicine, public domain)
- 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: 1 November 2024
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/NCT04349995.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing