Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

Official title:

Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04100720
• Other study ID #: CP 19-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2030

Study information

• Verified date: February 2023
• Source: Boston Biomedical Associates
• Contact: Lauren Baker, PhD
• Phone: (508) 351-8632
• Email: lbaker[@]boston-biomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

Description:

The Cardiovalve Transfemoral System for tricuspid valve replacement Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

1. Participant is 85 = Age = 18 years

2. Participant has severe, symptomatic tricuspid regurgitation (TR) = 3+ based upon echocardiography, as assessed by Independent core laboratory

3. Participant is New York Heart Association (NYHA) Class II-IVa

4. Participant has left ventricular ejection fraction (LVEF) = 35%

5. Participant distance of 6 minute walk test (6MWT) = 60 m

6. Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation and Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.

7. Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System

8. Participant approved by the Subject Screening Committee

Exclusion Criteria:

1. Known significant intracardiac shunt (e.g. septal defect) or congenital structural heart disease (PFO's without significant shunts are allowed)

2. Significant coronary artery disease requiring treatment

3. Primary tricuspid disease (e.g. rheumatic, myxomatous degeneration, tricuspid valve prolapse)

4. Severe right ventricular failure per ASE guidelines1

5. Systolic pulmonary arterial pressure > 65 mmHg as assessed by transthoracic echocardiography

6. Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year

7. Cerebrovascular event (stroke, TIA) within the past 3 months

8. Active endocarditis or history of mitral/tricuspid endocarditis within the last 12 months

9. Patient has significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)

10. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k)

11. Documented evidence of significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on any form of dialysis at time of screening within the last 4 weeks

12. Contraindication or known allergy to device's components, to anti-coagulation therapy with vitamin K antagonists or to contrast media that cannot be adequately premedicated

13. Patients unsuitable for implantation because of thrombosis of the lower venous system or presence of a vena cava filter

14. The patient has contraindication against a transesophageal echo (TEE) during the procedure

15. Evidence of an acute myocardial infarction (AMI) = 1 month (30 days)

16. Hepatic insufficiency (MELD > 10)

17. Female patient of child-bearing potential

18. Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol

19. Requirement for Antibiotic Treatment within the last 48 hours

20. Cardiac Anatomy deemed not suitable for the Cardiovalve Implant

21. Surgical or interventional procedure planned within 30 days prior to index procedure

22. UNOS Status 1 heart transplant or prior orthotropic heart transplantation.

23. Any prior Tricuspid valve surgery or transcatheter Tricuspid valve procedure

24. Modified Rankin Scale > 4 disability

25. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure

26. Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of index procedure

27. Currently participating in an investigational drug or another device study which has not reached its primary endpoint

28. Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment

29. Chronic oral steroid or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease).

30. Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope ) at the time of screening

31. Severe COPD or continuous use of home oxygen

32. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

33. Aortic or pulmonic valve disease requiring surgery

34. Venous peripheral anatomy unsuitable for implant delivery

35. Chronic anemia (Hgb < 9)

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Cardiovalve Transfemoral Tricuspid Valve
The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Northwestern University / Bluhm Cardiovascular Institute	Chicago	Illinois
United States	Columbia University Medical Center / NYPH	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Boston Biomedical Associates	Cardiovalve Ltd., Cardiovascular Research Foundation, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant	Cardiovalve Technical Success defined as: I Successful access, delivery and retrieval of the delivery system; II Successful deployment of correct positioning of the first intended implant; III Freedom from emergency surgery or reintervention related to the device or access procedure without any procedural mortality, stroke, and device dysfunction at 30-day follow-up.	30 Days
Primary	Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline	Cardiovalve Clinical Performance will be evaluated as: I The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline; II The reduction in degree of tricuspid regurgitation measured at the time of discharge or 7 days post procedure, whichever comes first, in comparison with baseline; Tricuspid Regurgitation is measured using Echocardiography and is graded based on degree of severity using grading conventions from 0 to 4+.; 0 = absent; = mild; = moderate; = moderate to severe; = severe	30 Days
Primary	Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days	The ability of the Cardiovalve to be implanted without Major Device Related Adverse Events through thirty (30) days including: I Death (Cardiovascular mortality vs non-cardiovascular); II Reintervention (operative or transcatheter) due to progressive or recurrent TR or device related complications; III Disabling stroke; IV Myocardial infarction (MVARC definition); V Major access site and vascular complications; VI Fatal or life-threatening bleeding (MVARC Type III-V); VII Arrhythmia and conduction disorder requiring permanent pacing; VIII Right coronary artery occlusion requiring intervention; IX Cardiac tamponade, X Renal failure requiring dialysis	30 Days
Secondary	Secondary Performance Endpoint - Tricuspid Regurgitation Severity	Tricuspid Regurgitation is measured using Echocardiography and is graded based on degree of severity using grading conventions from 0 to 4+.; 0 = absent; = mild; = moderate; = moderate to severe; = severe	30 days, 3 months, 6 months
Secondary	Secondary Performance Endpoint - Cusp Insufficiency	Cusp Insufficiency: Change in the degree of the cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value	30 days, 3 months, 6 months
Secondary	Secondary Performance Endpoint - Unrestricted Movement of Cusps	Unrestricted Movement of Cusps: the percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography	30 days, 3 months, 6 months
Secondary	Secondary Performance Endpoint - New York Heart Association (NYHA) functional class	NYHA function class I - IV; Higher functional class represents more severe symptoms of heart failure; NYHA Classification - The Stages of Heart Failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.; Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.; Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.	30 days, 3 months, 6 months
Secondary	Secondary Performance Endpoint - 6 minute walk test	6 minute walk test distance (meters)	30 days, 3 months, 6 months
Secondary	Secondary Performance Endpoint - Kansas City Cardiomyopathy Questionnaire	Kansas City Cardiomyopathy Questionnaire (KCCQ) - 23 subjective quality of life questions. Assessed before and after implantation. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.; There are 3 subscales: Symptom Burden - range 0-100; Physical Limitation - range 0-100; Quality of Life - range 0-100; The total KCCQ score represents the mean (average) of the three subscale scores.	30 days, 3 months, 6 months