Who is sponsoring NCT04375332?

NCT04375332 is sponsored by Edwards Lifesciences.

What drugs are being tested in NCT04375332?

Interventions in NCT04375332: HARPOON™ Beating Heart Mitral Valve Repair System.

What condition does NCT04375332 study?

NCT04375332 studies Mitral Regurgitation.

Is NCT04375332 still recruiting?

NCT04375332 is currently active, enrolled. Last updated 26 August 2025.

Last reviewed 2025-08-26 · How we verify

NCT04375332: RESTORE

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

Beating Heart Mitral Valve Repair With the HARPOON™ System

Active, enrolled NA Last updated 26 August 2025

What this trial tests

NA trial testing HARPOON™ Beating Heart Mitral Valve Repair System in Mitral Regurgitation in 25 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 December 2020

Primary endpoint
20 December 2027

20 December 2027

Quick facts

Lead sponsor	Edwards Lifesciences
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	16 December 2020
Primary completion	20 December 2027
Estimated completion	20 December 2027
Sites	9 locations across United States

Drugs / interventions tested

HARPOON™ Beating Heart Mitral Valve Repair System

Conditions studied

Mitral Regurgitation — all drugs for Mitral Regurgitation →

Sponsor

Edwards Lifesciences — full company profile →

Who can join

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

Sponsor's own description

The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).

Publications & conference data

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

Transcatheter mitral valve repair: an overview of current and future devices.
De Backer O, Wong I, Taramasso M, Maisano F, et al · · 2021 · cited 25× · PMID 33911022 · DOI 10.1136/openhrt-2020-001564
Transcatheter Mitral Valve Intervention: Current and Future Role of Multimodality Imaging for Device Selection and Periprocedural Guidance.
Brugiatelli L, Rolando M, Lofiego C, Fogante M, et al · · 2024 · cited 3× · PMID 39064511 · DOI 10.3390/medicina60071082

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 Edwards Lifesciences trials

Trials by the same sponsor.

NCT07317648 — ClearSight NextGen1 Study · NA · completed
NCT06833476 — TTVR STRONG Under Coverage With Evidence Development (CED) Study · recruiting
NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting
NCT06834516 — ClearSight Baby Cuff · completed
NCT05957406 — SMART TRENDS Study · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04375332 (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 Edwards Lifesciences
Last refreshed: 26 August 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/NCT04375332.

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