Last reviewed · How we verify
NCT03453853: AFRICA
Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)
Phase 1, PHASE2 trial testing Mitral Loop Cerclage Annuloplasty in Atrial Functional Mitral Regurgitation in 1 participant. Completed in 3 April 2021.
17 November 2018
Quick facts
| Lead sponsor | Tau-MEDICAL Co., Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 2 April 2018 |
| Primary completion | 17 November 2018 |
| Estimated completion | 3 April 2021 |
| Sites | 7 locations across South Korea |
Drugs / interventions tested
- Mitral Loop Cerclage Annuloplasty
Conditions studied
- Atrial Functional Mitral Regurgitation — all drugs for Atrial Functional Mitral Regurgitation →
- Heart Failure — all drugs for Heart Failure →
Sponsor
Tau-MEDICAL Co., Ltd. — full company profile →
Who can join
Adults 20 to 85, any sex, with Atrial Functional Mitral Regurgitation or Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Emerging Technologies for Percutaneous Mitral Valve Repair.
Mangieri A, Laricchia A, Giannini F, Gallo F, et al · · 2019 · cited 11× · PMID 31781576 · DOI 10.3389/fcvm.2019.00161
Verify or expand the search:
- PubMed search for NCT03453853
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atrial Functional Mitral Regurgitation
Currently open trials in the same condition.
- NCT06883864 — Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation · NA · recruiting
- NCT06630936 — Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation · recruiting
- NCT06911099 — Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR) · recruiting
Other Tau-MEDICAL Co., Ltd. trials
Trials by the same sponsor.
- NCT05854238 — The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF Ablation · NA · terminated
- NCT05854095 — The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR · NA · completed
- NCT05648838 — Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR · NA · completed
- NCT04770142 — First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation · NA · terminated
- NCT03438591 — The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT) · NA · completed
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 NCT03453853 (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 Tau-MEDICAL Co., Ltd.
- Last refreshed: 26 April 2021
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/NCT03453853.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing