Mitral RegurgitationRESTORENCT04375332
Beating Heart Mitral Valve Repair With the HARPOON™ System
A study testing HARPOON™ Beating Heart Mitral Valve Repair System in people with Mitral Regurgitation, run by Edwards Lifesciences at 9 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- HARPOON™ Beating Heart Mitral Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesUnited States
- Study dates
- 16 Dec 2020to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject is required to meet all of the following inclusion criteria:
- Patient is >/= 21 years old.
- Presence of severe degenerative mitral regurgitation with mid-segment posterior leaflet prolapse (without commissural involvement) by echocardiographic study.
- Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without undue leaflet tension, based on the judgment of the Echocardiographic Core Lab.
- Patient competent to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation.
Who cannot join
- Patients will be excluded if ANY of the following criteria apply:
- Functional mitral regurgitation (FMR).
- Evidence of anterior or bileaflet prolapse.
- Severe mitral annular calcification (MAC).
- Moderate or greater leaflet calcification.
- Fragile or thinning apex (e.g. LV aneurysm).
Show all 36Show fewer
- Have undergone cardiac or peripheral vascular procedures within 30 days prior to the trial procedure.
- Planned cardiac or peripheral vascular procedures within 30 days after the trial procedure.
- Requirement for concomitant cardiac surgery.
- Severe pulmonary hypertension (pulmonary artery systolic pressure > 60mmHg).
- Severe aortic stenosis or insufficiency.
- Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid regurgitation are not excluded.)
- Left ventricular ejection fraction (LVEF) <30%, or severely impaired right ventricular dysfunction as measured by the core lab.
- Any history of endocarditis.
- Contraindication to cardiac surgery, including hostile chest or history of mediastinal radiation.
- Previous structural heart intervention (e.g. any heart valve replacement or repair procedures). Previous percutaneous coronary intervention (PCI) is allowed.
- Previous coronary artery bypass grafting (CABG).
- Stroke within 30 days prior to index procedure.
- ST segment elevation myocardial infarction (STEMI) requiring intervention within 30 days prior to index procedure.
- Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, [or MELD score of ≥ 13]).
- Renal insufficiency CKD Stage 3b or worse (GFR < 45 ml/min/1.73 m2).
- Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g. requiring inotropic support or mechanical support devices).
- History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL).
- Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments (as assessed by Case Review Committee).
- Refuse blood products.
- Planned treatment with any other investigational device or procedure through 1-year follow-up, or who are currently participating in an investigational drug or device trial.
- Carotid stenosis ≥ to 80% at time of enrollment.
- Rheumatic heart disease including rheumatic mitral stenosis.
- Pregnant or lactating at the time of enrollment (women of childbearing age should have negative pregnancy test within 72 hours of surgery) or planning pregnancy within the next 12 months.
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator.
- Condition or conditions that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
- Contraindication for transesophageal echocardiography (TEE), including esophageal spasm, esophageal stricture, esophageal laceration, esophageal perforation, esophageal diverticula (e.g. Zenker's diverticulum).
- Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or appendage thrombus, myxoma, or vegetation).
- Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen.
- Intra-operative exclusion criteria
- No longer meets eligibility criteria based on intra-operative assessment.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Atlanta, Georgia, 30309
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins
Baltimore, Maryland, 21231
Intermountain Heart Institute
Murray, Utah, 84107
Centennial Medical Center
Nashville, Tennessee, 37203
OHSU Knight Cardiovascular Institute
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55902
UCSF
San Francisco, California, 94118
About this study
Official title: A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)
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).
Read the detailed description
RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).
- Conditions
- Mitral Regurgitation
- Being tested
- HARPOON™ Beating Heart Mitral Valve Repair System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARPOON™ Beating Heart Mitral Valve Repair SystemDevice
Repair of the chordae tendinae in the mitral valve.
| Study group | Role | What they receive |
|---|---|---|
| HARPOON™ Beating Heart Mitral Valve Repair System | Experimental | Subjects who were treated with the HARPOON™ Beating Heart Mitral Valve Repair System Receives: Device: HARPOON™ Beating Heart Mitral Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NYHA classification from Baseline to 5 years
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Symptoms of heart failure or the anginal syndrome may be present even at rest.
Measured: Baseline compared to 1 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start16 Dec 2020
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinod H. Thourani, MD, Principal investigator, Dept of Cardiovascular Surgery, Piedmont Heart InstituteKonstantinos Koulogiannis, MD, Principal investigator, Department of Cardiovascular Medicine Gagnon Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375332
- Sponsor's protocol ID
- 2019-05
- Acronym
- RESTORE
- Status last verified
- Aug 2026
- First submitted
- 1 May 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)
- ClinicalTrials.gov ID
- NCT04375332
- Acronym / sponsor ID
- RESTORE / 2019-05
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HARPOON™ Beating Heart Mitral Valve Repair System | Experimental | Device: HARPOON™ Beating Heart Mitral Valve Repair SystemSubjects who were treated with the HARPOON™ Beating Heart Mitral Valve Repair System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is >/= 21 years old.
- Presence of severe degenerative mitral regurgitation with mid-segment posterior leaflet prolapse (without commissural involvement) by echocardiographic study.
- Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without undue leaflet tension, based on the judgment of the Echocardiographic Core Lab.
- Patient competent to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation.
Key exclusion criteria (36 listed)
- Functional mitral regurgitation (FMR).
- Evidence of anterior or bileaflet prolapse.
- Severe mitral annular calcification (MAC).
- Moderate or greater leaflet calcification.
- Fragile or thinning apex (e.g. LV aneurysm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HARPOON™ Beating Heart Mitral Valve Repair SystemRepair of the chordae tendinae in the mitral valve. | Device | HARPOON™ Beating Heart Mitral Valve Repair System |
Primary outcome
Change in NYHA classification from Baseline to 5 years
Time frame: Baseline compared to 1 and 5 years
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinod H. Thourani, MD principal investigator
Dept of Cardiovascular Surgery, Piedmont Heart Institute
Konstantinos Koulogiannis, MD principal investigator
Department of Cardiovascular Medicine Gagnon Cardiovascular Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARPOON™ Beating Heart Mitral Valve Repair System in people with Mitral Regurgitation, run by Edwards Lifesciences at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NYHA classification from Baseline to 5 years (time frame: Baseline compared to 1 and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.