Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System

Mitral Regurgitation Clinical Trial

Official title:

Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03714412
• Other study ID #: CL008
• Status: Withdrawn
• Phase: N/A
• Start date: September 2019
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2019
• Source: Cardiovalve Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.

Description:

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. The implant procedure is performed under general anesthesia, and the participants will be followed-up at discharge, 1- 3-, 6-, 12- and 24-months post-procedure, in order to check the system functionality and effect on their cardiology status.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General Inclusion Criteria:

2. NYHA functional II, III or ambulatory IV 3. Severe mitral regurgitation (MR grade 3-4+) with pronounced secondary MR etiology 4. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.

5. Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.

6. Able to undergo Transesophageal Echocardiography (TEE). 7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

8. The subject commits to return for the scheduled post-operative follow-up visits at the hospital.

Anatomical Inclusion Criteria 9. Suitable for femoral access procedure and trans septal catheterization 10. Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee)

Exclusion Criteria:

Cardiovascular Exclusion Criteria

1. Prior stroke or TIA within 3 months or Modified Rankin Scale =4 disability

2. Acute myocardial infarction within the previous 30 days

3. Any prior heart valve surgery or transcatheter mitral intervention

4. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days

5. Rheumatic heart disease or endocarditis within the previous 3 months

6. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology

7. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)

8. Untreated clinically signi?cant coronary artery disease requiring revascularization

9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation

10. Aortic or pulmonic valve disease requiring surgery

11. CRT/ICD implant within 30 days Anatomical Exclusion Criteria (assessed by pre-procedural imaging)

12. Left Ventricular Ejection Fraction (LVEF) <30%

13. LV end diastolic diameter > 70mm

14. Significant abnormalities of the mitral valve and sub-valvular apparatus.

15. Severe mitral annular or leaflets calcification

16. Left atrial or LV thrombus or vegetation

17. Severe right ventricular dysfunction

18. Severe tricuspid or aortic valve disease

General Exclusion Criteria

19. Subject who is currently participating in an investigational study, other than this study

20. Hemodynamic instability defined as systolic pressure < 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance

21. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications

22. Bleeding diathesis or hypercoagulable state

23. Active peptic ulcer or active gastrointestinal bleeding

24. Pulmonary artery systolic pressure >70 mmHg

25. Patients with renal insufficiency (creatinine > 2.5 mg/dL)

26. Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months

27. Subject with hepatic insufficiency

28. Subject has a co-morbid illness that may result in a life expectancy of less than one year

29. Active infection that requires antibiotic therapy

30. Subject is pregnant, breastfeeding or intend to become pregnant within one year

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Implantation
Implantation of the Cardiovalve transfemoral mitral valve replacement system

Locations

Country	Name	City	State
Greece	Hygeia Hospital	Athens
Poland	Silesian Center for Heart Diseases	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovalve Ltd.

Countries where clinical trial is conducted

Greece,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major device- or procedure- related serious adverse events	Evaluate the safety of the Cardiovalve with its associated procedure	30 days
Secondary	Technical success of delivery and deployment of the device	Technical success of delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis	Intraoperative
Secondary	Freedom from emergency surgery or reintervention	Freedom from emergency surgery or reintervention related to the device or access procedure	30 days
Secondary	Freedom from rehospitalizations or reinterventions due to the underlying condition	Freedom from rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, worsening of heart failure)	30 days, 3 Months, 6 Months, 12 Months, and 24 Months
Secondary	Reduction in MR grade	Reduction in MR grade to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) Number of patients with reduction in MR grade from baseline	30 days, 3-, 6-, 12 and 24-months
Secondary	NYHA class	Improvement from baseline in NYHA functional class; Number of patients with improvement in NYHA class	30 days, 3-, 6-, 12 and 24-months
Secondary	6 minute walk test	Increase in distance from baseline	30 days, 3-, 6-, 12 and 24-months
Secondary	Improvement in quality of life from baseline	Improvement from baseline in quality-of-life (Kansas City Cardiomyopathy Questionnaire improvement by = 10)	30 days, 3-, 6-, 12 and 24-months