Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation

Mitral Regurgitation Clinical Trial

— EXPLORE MR  

Official title:

Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation (EXPLORE MR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04098328
• Other study ID #: 201901
• Status: Terminated
• Start date: January 1, 2020
• Est. completion date: February 2, 2023

Study information

• Verified date: February 2022
• Source: Polares Medical SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Early feasibility study, single-arm registry design

Description:

First-In-Human

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older.

2. Greater than moderate degenerative or functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure

3. Patient must present with an STS Score less than 10%

4. High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure

5. Mitral valve anatomy deemed unsuitable to be treated with an approved edge-to-edge repair system (e.g., retracted posterior leaflet, lack of leaflet tissue, calcified or cleft posterior leaflet) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure

6. Patient is approved by an independent Patient Eligibility Committee

7. New York Heart Association (NYHA) Functional Class III or IV

8. Patient willing to participate in study and provide signed EC-approved informed consent.

9. Treating physician and patient agree that patient is able to return for all required post- procedure follow-up visits

10. Women of child-bearing potential have a negative pregnancy test

Exclusion Criteria:

1. Severe tricuspid regurgitation

2. Severe aortic stenosis or insufficiency

3. Severe mitral annulus calcification

4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification

5. Implanted vena cava filter

6. Femoral veins with severe angulation and calcification

7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan.

8. Active infection or endocarditis

9. Previous mitral valve surgery

10. Prior orthotopic heart transplantation

11. Pulmonary artery systolic hypertension > 70mmHg

12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus

13. Left ventricular ejection fraction (LVEF) < 30%

14. Implant or revision of any pacing device < 30 days prior to intervention

15. Symptomatic coronary artery disease treated < 30 days prior to study procedure

16. Myocardial infarction requiring intervention < 30 days prior to study procedure

17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis

18. Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure

19. Stroke < 180 days prior to study procedure

20. Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis

21. Cardiogenic shock at time of enrolment

22. Hemodynamic instability requiring inotropic support or mechanical heart assistance

23. Concurrent medical condition with a life expectancy of less than 2 years

24. Pregnancy at time of enrolment

25. History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)

26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated

27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments

28. Emergency situations

29. Company employees or their immediate family members

30. Patient is under guardianship

31. Patient is participating in another clinical study for which follow-up is currently ongoing

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Disease
• Mitral Valve Insufficiency

Locations

Country	Name	City	State
Germany	St. Johannes Hospital	Dortmund
Switzerland	Inselspital Bern	Bern
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Polares Medical SA

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety endpoint	All-cause mortality	30 days
Primary	Improvement from baseline mitral regurgitation	Grade 2+ or less as evaluated by 2D transthoracic echocardiography	30 days
Secondary	Technical success according to MVARC2 criteria	Absence of procedure mortality; Successful access, delivery and retrieval of investigation delivery system; Successful deployment and correct positioning of intended implant(s); Freedom from emergency surgery/re-intervention related to device or access procedure	24 hours
Secondary	Procedure success according to MVARC2 criteria	Absence of procedure mortality or stroke; Proper placement and positioning of device; Freedom from unplanned re-intervention related to device or access procedure; Continued intended safety and performance of the device: No evidence of structural or functional failure; No device technical failure issues/complications; MR reduction to moderate or less without stenosis; Absence of major device or procedure-related SAE: Death; Stroke; Life-threatening bleed; Major vascular complication; Major cardiac structural complication; No device technical failure issues/complications; Stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; Shock, heart or respiratory failure requiring IV vasopressors, mechanical intervention or prolonged intubation; Valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention	30 days
Secondary	Device success according to MVARC2 criteria	Absence of procedure mortality or stroke; Proper placement and positioning of device; Freedom from unplanned re-intervention related to device or access procedure; Continued intended safety and performance of the device: No evidence of structural or functional failure; No device technical failure issues/complications; MR reduction to moderate or less without stenosis	30 days, 6 and 12 months, and 2 - 5 years post treatment
Secondary	Patient success according to MVARC2 criteria	Device success; Patient returned to pre-procedure setting; No rehospitalization or reintervention for mitral regurgitation or heart failure; Functional improvement from baseline by one or more NYHA class; 6MWT improvement from baseline by 50 metres or more	30 days, 6 and 12 months, and 2 - 5 years post treatment
Secondary	Rate (%) of major adverse events as defined by MVARC2 criteria	All-cause mortality, hospitalization due to cardiac conditions, stroke or TIA, myocardial infarction, access site and vascular complications, bleeding complications, acute kidney injury up to 7 days post-procedure, and arrhythmias and conduction system disturbances	Procedure, discharge/7 days, 30 days, 6 and 12 months, and 2 - 5 years post treatment