Beating Heart Mitral Valve Repair With the HARPOON™ System
Public ClinicalTrials.gov record NCT04375332. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)
Study identification
- NCT ID
- NCT04375332
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Edwards Lifesciences
- Industry
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Interventions
- HARPOON™ Beating Heart Mitral Valve Repair System Device
Device
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2020
- Primary completion
- Dec 19, 2027
- Completion
- Dec 19, 2027
- Last update posted
- Aug 25, 2025
2020 – 2027
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF | San Francisco | California | 94118 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins | Baltimore | Maryland | 21231 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| OHSU Knight Cardiovascular Institute | Portland | Oregon | 97239 | — |
| Centennial Medical Center | Nashville | Tennessee | 37203 | — |
| Intermountain Heart Institute | Murray | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04375332, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2025 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04375332 live on ClinicalTrials.gov.