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

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ClinicalTrials.gov Identifier: NCT04375332
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : September 16, 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.


Secondary Outcome Measures :
  1. Blood Product Usage [ Time Frame: Intraoperatively or post-operatively until discharge ]
    Blood product usage intraoperatively or post-operatively until discharge, in the HARPOON System treatment arm vs. open surgery.

  2. Procedure Time [ Time Frame: First incision to incision close time ]
    Procedure time: first incision to incision close time in the HARPOON System treatment arm vs. open surgery.

  3. OR Time [ Time Frame: Entry to OR suite and exit from OR suite ]
    OR time: entry to OR suite and exit from OR suite in the HARPOON System treatment arm vs. open surgery.

  4. Total Ventilation Hours [ Time Frame: Discharge ]
    Total ventilation hours at discharge in the HARPOON System treatment arm vs. open surgery.

  5. Total Hours in ICU [ Time Frame: Post index procedure until discharge ]
    Total hours in the ICU post index procedure until discharge in the HARPOON System treatment arm vs. open surgery.

  6. Percentage of subjects receiving mitral valve replacement (MVR) [ Time Frame: During Index Procedure ]
    Percentage of subjects receiving mitral valve replacement (MVR) during the index procedure in the HARPOON System treatment arm vs. open surgery.

  7. Hospital Length of Stay (LOS) [ Time Frame: Post index procedure until discharge ]
    Hospital length of stay (LOS) post index procedure until discharge in the HARPOON System treatment arm vs. open surgery.

  8. Composite Effectiveness Endpoint [ Time Frame: One 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) mitral regurgitation (MR) for one year following the index procedure, in the HARPOON System treatment arm vs. CTSN-TR comparator.

  9. Discharged to Home vs. Other Facility [ Time Frame: Discharge ]
    Discharged to home vs. other facility, in the HARPOON System treatment arm vs. open surgery.



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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 ventricular ejection fraction (LVEF) <30%, or severely impaired right ventricular dysfunction 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). Previous percutaneous coronary intervention (PCI) is allowed.
  16. Previous coronary artery bypass grafting (CABG).
  17. Stroke within 30 days prior to index procedure.
  18. ST segment elevation myocardial infarction (STEMI) requiring intervention within 30 days prior to index procedure.
  19. Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, [or MELD score of ≥ 13]).
  20. Renal insufficiency CKD Stage 3b or worse (GFR < 45 ml/min/1.73 m2).
  21. Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g. requiring inotropic support or mechanical support devices).
  22. 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).
  23. 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).
  24. Refuse blood products.
  25. 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.
  26. Carotid stenosis ≥ to 80% at time of enrollment.
  27. Rheumatic heart disease including rheumatic mitral stenosis.
  28. 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.
  29. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator.
  30. Condition or conditions that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
  31. Contraindication for transesophageal echocardiography (TEE), including esophageal spasm, esophageal stricture, esophageal laceration, esophageal perforation, esophageal diverticula (e.g. Zenker's diverticulum).
  32. Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or appendage thrombus, myxoma, or vegetation).
  33. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen.

    Intra-operative exclusion criteria

  34. 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
Show Show 21 study locations
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: September 16, 2021
Last Verified: September 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