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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04098328
Other study ID # 201901
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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