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NCT04666467: EXPLORE FMR
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation ( EXPLORE FMR )
NA trial testing Transcatheter mitral valve repair in Functional Mitral Regurgitation. Withdrawn.
31 December 2022
Quick facts
| Lead sponsor | Polares Medical SA |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Start date | 1 April 2021 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Transcatheter mitral valve repair
Conditions studied
- Functional Mitral Regurgitation — all drugs for Functional Mitral Regurgitation →
Sponsor
Polares Medical SA
Who can join
18 and older, any sex, with Functional Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at up to 4 centers in North America.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04666467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Transcatheter mitral valve repair
Trials testing the same drug.
- NCT05391802 — The Multicenter Clinical Trial of a Novel TEER Decive (V-CLASP Trial) · NA · unknown
- NCT04666480 — Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation · NA · terminated
Other recruiting trials for Functional Mitral Regurgitation
Currently open trials in the same condition.
- NCT06823700 — Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU · NA · recruiting
- NCT05991284 — Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation · Phase 4 · active not recruiting
- NCT05965258 — Phenotypic Classification of FMR With CMR · recruiting
- NCT03929913 — NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study · NA · active not recruiting
- NCT03706833 — Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial · NA · active not recruiting
Other Polares Medical SA trials
Trials by the same sponsor.
- NCT07517588 — EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States) · NA · not yet recruiting
- NCT04666480 — Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation · NA · terminated
- NCT04098328 — Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation · terminated
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 NCT04666467 (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 Polares Medical SA
- Last refreshed: 20 December 2023
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/NCT04666467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing