Who is sponsoring NCT05061004?

NCT05061004 is sponsored by Abbott Medical Devices.

What drugs are being tested in NCT05061004?

Interventions in NCT05061004: Cephea Mitral Valve System.

What condition does NCT05061004 study?

NCT05061004 studies Mitral Regurgitation.

Is NCT05061004 still recruiting?

NCT05061004 is currently recruiting now. Last updated 8 April 2026.

Last reviewed 2026-04-08 · How we verify

NCT05061004

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cephea Early Feasibility Study

Recruiting now NA Last updated 8 April 2026

What this trial tests

NA trial testing Cephea Mitral Valve System in Mitral Regurgitation in 50 participants. Currently enrolling.

Timeline

28 April 2022

Primary endpoint
31 December 2026

1 March 2031

Quick facts

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	28 April 2022
Primary completion	31 December 2026
Estimated completion	1 March 2031
Sites	22 locations across Canada, United States

Drugs / interventions tested

Cephea Mitral Valve System

Conditions studied

Mitral Regurgitation — all drugs for Mitral Regurgitation →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Mitral Interventions in Heart Failure.
Lander MM, Brener MI, Goel K, Tang PC, et al · · 2023 · cited 11× · PMID 37611988 · DOI 10.1016/j.jchf.2023.07.016
Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valve or Dedicated Devices: Current Evidence and Future Prospects.
Quentin V, Mesnier J, Delhomme C, Sayah N, et al · · 2023 · cited 8× · PMID 37959178 · DOI 10.3390/jcm12216712
Transcatheter mitral valve implantation for native valve disease.
Urena M, Lurz P, Sorajja P, Himbert D, et al · · 2023 · cited 6× · PMID 37994096 · DOI 10.4244/eij-d-22-00890
TMVR for the Treatment of Mitral Regurgitation: A State-of-the-Art Review.
Tartaglia F, Antonelli G, Gitto M, Stankowski K, et al · · 2025 · cited 1× · PMID 40927837 · DOI 10.1161/circinterventions.125.015298
Transfemoral Transcatheter Mitral Valve Implantation With a Dedicated Device in a Rheumatic Mitral Stenosis Patient.
Ranard LS, Grizzell BE, Vahl TP, Granada JF, et al · · 2023 · cited 1× · PMID 37790763 · DOI 10.1016/j.jaccas.2023.101986
Contemporary Transcatheter Approaches to Mitral Regurgitation
Theofilis P, Iliakis P, Dimitriadis K, Karakasis P, et al · · 2026
Transcatheter Valve Replacement for Mitral Stenosis: A State of the Art Review.
Comis A, Sanfilippo C, Immè S, Tamburino CI, et al · · 2026 · PMID 41899297 · DOI 10.3390/jcm15062373
Transcatheter mitral valve options for severe mitral annular calcification.
Onishi T, El-Eshmawi A, Lerakis S, Safi LM, et al · · 2025 · PMID 41383202 · DOI 10.21037/acs-2025-mac-11

Verify or expand the search:

Other recruiting trials for Mitral Regurgitation

Currently open trials in the same condition.

NCT07450911 — A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System · Phase 1 · recruiting
NCT07366723 — The Role of cardIac magNeTic rEsonance in surGical Decision Making in Patients With Severe pRimAry miTral rEgurgitation · NA · active not recruiting
NCT07007143 — STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication fo · Phase 4 · recruiting
NCT07108907 — Outcome Registry and Assessment of New Edge-to-Edge Repair · recruiting
NCT06901466 — STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for O · Phase 4 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05061004 (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: 8 April 2026

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/NCT05061004.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing