Beating Heart Mitral Valve Repair With the HARPOON™ System

Mitral Regurgitation Clinical Trial

— RESTORE  

Official title:

A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04375332
• Other study ID #: 2019-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 2027
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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 mid-segment posterior leaflet prolapse (without commissural involvement) 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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• HARPOON™ Beating Heart Mitral Valve Repair System
Repair of the chordae tendinae in the mitral valve.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre University Hospital	London	Ontario
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	Hartford Hospital	Hartford	Connecticut
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	UCLA	Los Angeles	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Heart Institute	Murray	Utah
United States	Centennial Medical Center	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Weill-Cornell	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Advent Health Florida Hospital	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	OHSU Knight Cardiovascular Institute	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Barnes-Jewish/Washington University	Saint Louis	Missouri
United States	UCSF	San Francisco	California
United States	Sarasota Memorial Health Care System	Sarasota	Florida
United States	Swedish Medical Center	Seattle	Washington
United States	UPMC/Pinnacle Health Hospitals	Wormleysburg	Pennsylvania
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Safety Endpoints	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.	Discharge from the hospital or 30-days following the index procedure, whichever is longer.
Primary	Composite Effectiveness Endpoints	Composite effectiveness endpoint, defined as freedom-from all-cause mortality, re-intervention on the mitral valve and recurrent [moderate or severe] MR.	1 year following the index procedure.
Secondary	Blood Product Usage	Blood product usage intraoperatively or post-operatively until discharge, in the HARPOON System treatment arm vs. open surgery.	Intraoperatively or post-operatively until discharge
Secondary	Procedure Time	Procedure time: first incision to incision close time in the HARPOON System treatment arm vs. open surgery.	First incision to incision close time
Secondary	OR Time	OR time: entry to OR suite and exit from OR suite in the HARPOON System treatment arm vs. open surgery.	Entry to OR suite and exit from OR suite
Secondary	Total Ventilation Hours	Total ventilation hours at discharge in the HARPOON System treatment arm vs. open surgery.	Discharge
Secondary	Total Hours in ICU	Total hours in the ICU post index procedure until discharge in the HARPOON System treatment arm vs. open surgery.	Post index procedure until discharge
Secondary	Percentage of subjects receiving mitral valve replacement (MVR)	Percentage of subjects receiving mitral valve replacement (MVR) during the index procedure in the HARPOON System treatment arm vs. open surgery.	During Index Procedure
Secondary	Hospital Length of Stay (LOS)	Hospital length of stay (LOS) post index procedure until discharge in the HARPOON System treatment arm vs. open surgery.	Post index procedure until discharge
Secondary	Composite Effectiveness Endpoint	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.	One year following the index procedure
Secondary	Discharged to Home vs. Other Facility	Discharged to home vs. other facility, in the HARPOON System treatment arm vs. open surgery.	Discharge