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Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375332
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief 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).

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: HARPOON™ Beating Heart Mitral Valve Repair System Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2027

Arm Intervention/treatment
Experimental: HARPOON™ Beating Heart Mitral Valve Repair System
Subjects who were treated with the HARPOON™ Beating Heart Mitral Valve Repair System
Device: HARPOON™ Beating Heart Mitral Valve Repair System
Repair of the chordae tendinae in the mitral valve.




Primary Outcome Measures :
  1. Composite Safety Endpoints [ Time Frame: Discharge from the hospital or 30-days following the index procedure, whichever is longer. ]
    Composite safety endpoint, defined as freedom-from all-cause mortality, stroke, acute kidney injury (AKI), major bleeding, new permanent pace-maker implantation, deep sternal wound infection (DSWI) or wound infection requiring surgical intervention, and prolonged mechanical ventilation.

  2. Composite Effectiveness Endpoints [ Time Frame: 1 year following the index procedure. ]
    Composite effectiveness endpoint, defined as freedom-from all-cause mortality, re-intervention on the mitral valve and recurrent [moderate or severe] MR.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject is required to meet all of the following inclusion criteria:

  1. Patient is >/= 21 years old.
  2. Presence of severe degenerative mitral regurgitation with isolated mid-segment posterior leaflet prolapse by echocardiographic study.
  3. Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without undue leaflet tension, based on the judgment of the Echocardiographic Core Lab.
  4. 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.

Exclusion Criteria:

Patients will be excluded if ANY of the following criteria apply:

  1. Functional mitral regurgitation (FMR).
  2. Evidence of anterior or bileaflet prolapse.
  3. Severe mitral annular calcification (MAC).
  4. Moderate or greater leaflet calcification.
  5. Fragile or thinning apex (e.g. LV aneurysm).
  6. Have undergone cardiac or peripheral vascular procedures within 30 days prior to the trial procedure.
  7. Planned cardiac or peripheral vascular procedures within 30 days after the trial procedure.
  8. Requirement for concomitant cardiac surgery.
  9. Severe pulmonary hypertension (pulmonary artery systolic pressure > 60mmHg).
  10. Severe aortic stenosis or insufficiency.
  11. Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid regurgitation are not excluded.)
  12. Left or right ventricular ejection fraction (LVEF or RVEF) <30% as measured by the core lab.
  13. Any history of endocarditis.
  14. Contraindication to cardiac surgery, including hostile chest or history of mediastinal radiation.
  15. Previous structural heart intervention (e.g. any heart valve replacement or repair procedures) with the exceptions of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
  16. Stroke within 30 days prior to index procedure.
  17. ST segment elevation myocardial infarction (STEMI) requiring intervention within 30 days prior to index procedure.
  18. Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, [or MELD score of ≥ 13]).
  19. Renal insufficiency CKD Stage 3b or worse (GFR < 45 ml/min/1.73 m2).
  20. Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g. requiring inotropic support or mechanical support devices).
  21. 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).
  22. Refuse blood products.
  23. 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.
  24. Carotid stenosis ≥ to 80% at time of enrollment.
  25. Rheumatic heart disease including rheumatic mitral stenosis.
  26. 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.
  27. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator.
  28. Condition or conditions that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
  29. Contraindication for transesophageal echocardiography (TEE), including esophageal spasm, esophageal stricture, esophageal laceration, esophageal perforation, esophageal diverticula (e.g. Zenker's diverticulum).
  30. Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or appendage thrombus, myxoma, or vegetation).
  31. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen.

    Intra-operative exclusion criteria

  32. No longer meets eligibility criteria based on intra-operative assessment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375332


Contacts
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Contact: Stephanie Plaza, MPH 949-250-8458 Stephanie_Plaza@edwards.com

Locations
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United States, California
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Stephanie Mullin    323-442-6226    Stephanie.Mullin@med.usc.edu   
Principal Investigator: Mark Cunningham, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Tiffany Flores    650-725-8718    Tflores2@Stanford.edu   
Principal Investigator: John MacArthur, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Denise White    404-605-3561    Denise.whyte@piedmont.org   
Principal Investigator: Federico Milla, MD         
United States, Indiana
St. Vincent Hospital Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Rachel Johnson    317-583-7804    rachel.johnson6@ascension.org   
Principal Investigator: David Heimansohn, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Freshta Akbari    410-328-9409    FAkbari@som.umaryland.edu   
Principal Investigator: Murtaza Dawood, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Annika Gallandt    617-643-9324    AGALLANDT@mgh.harvard.edu   
Principal Investigator: Serguei Melnitchouk, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nicole Schuler    734-232-4297    gervais@med.umich.edu   
Principal Investigator: Matthew Romano, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Wendy Sundt    507-293-4234    Sundt.Wendy@mayo.edu   
Principal Investigator: Arman Arghami, MD         
United States, Missouri
Barnes-Jewish/Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kelly Koogler    314-362-3043    Kooglerk@wustl.edu   
Principal Investigator: Spencer Melby, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eva Laverty       Eva.Laverty-Wilson@pennmedicine.upenn.edu   
Principal Investigator: Wilson Szeto, MD         
UPMC/Pinnacle Health Hospitals Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Regina Hollister, RN       hollisterr@upmc.edu   
Principal Investigator: Mubashir Mumtaz, MD         
United States, Utah
Intermountain Heart Institute Recruiting
Murray, Utah, United States, 84107
Contact: Erika Hummel    801-507-4731    Erika.Hummel@imail.org   
Principal Investigator: John Doty, MD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Vinod H. Thourani, MD Dept of Cardiovascular Surgery, Piedmont Heart Institute
Principal Investigator: Konstantinos Koulogiannis, MD Department of Cardiovascular Medicine Gagnon Cardiovascular Institute
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04375332    
Other Study ID Numbers: 2019-05
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases