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Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

Primary Purpose

Tricuspid Regurgitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiovalve Transfemoral Tricuspid Valve
Sponsored by
Boston Biomedical Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern University / Bluhm Cardiovascular Institute
  • Montefiore Medical Center
  • Columbia University Medical Center / NYPH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiovalve Transfemoral Tricuspid Valve

Arm Description

Replacement (Implant) delivered through a transfemoral access

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

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
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
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
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.
Secondary Performance Endpoint - 6 minute walk test
6 minute walk test distance (meters)
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.

Full Information

First Posted
September 10, 2019
Last Updated
February 9, 2023
Sponsor
Boston Biomedical Associates
Collaborators
Cardiovalve Ltd., Cardiovascular Research Foundation, New York
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1. Study Identification

Unique Protocol Identification Number
NCT04100720
Brief Title
Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation
Official Title
Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Biomedical Associates
Collaborators
Cardiovalve Ltd., Cardiovascular Research Foundation, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiovalve Transfemoral Tricuspid Valve
Arm Type
Experimental
Arm Description
Replacement (Implant) delivered through a transfemoral access
Intervention Type
Device
Intervention Name(s)
Cardiovalve Transfemoral Tricuspid Valve
Intervention Description
The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation
Primary Outcome Measure Information:
Title
1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant
Description
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.
Time Frame
30 Days
Title
Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline
Description
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
Time Frame
30 Days
Title
Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days
Description
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
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Secondary Performance Endpoint - Tricuspid Regurgitation Severity
Description
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
Time Frame
30 days, 3 months, 6 months
Title
Secondary Performance Endpoint - Cusp Insufficiency
Description
Cusp Insufficiency: Change in the degree of the cusp insufficiency as assessed with echocardiography (ordinal) from a higher to a lower value
Time Frame
30 days, 3 months, 6 months
Title
Secondary Performance Endpoint - Unrestricted Movement of Cusps
Description
Unrestricted Movement of Cusps: the percentage of medical devices with unrestricted movement of cusps after implantation as assessed with echocardiography
Time Frame
30 days, 3 months, 6 months
Title
Secondary Performance Endpoint - New York Heart Association (NYHA) functional class
Description
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.
Time Frame
30 days, 3 months, 6 months
Title
Secondary Performance Endpoint - 6 minute walk test
Description
6 minute walk test distance (meters)
Time Frame
30 days, 3 months, 6 months
Title
Secondary Performance Endpoint - Kansas City Cardiomyopathy Questionnaire
Description
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.
Time Frame
30 days, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is 85 ≥ Age ≥ 18 years Participant has severe, symptomatic tricuspid regurgitation (TR) ≥ 3+ based upon echocardiography, as assessed by Independent core laboratory Participant is New York Heart Association (NYHA) Class II-IVa Participant has left ventricular ejection fraction (LVEF) ≥ 35% Participant distance of 6 minute walk test (6MWT) ≥ 60 m 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. Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System Participant approved by the Subject Screening Committee Exclusion Criteria: Known significant intracardiac shunt (e.g. septal defect) or congenital structural heart disease (PFO's without significant shunts are allowed) Significant coronary artery disease requiring treatment Primary tricuspid disease (e.g. rheumatic, myxomatous degeneration, tricuspid valve prolapse) Severe right ventricular failure per ASE guidelines1 Systolic pulmonary arterial pressure > 65 mmHg as assessed by transthoracic echocardiography Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year Cerebrovascular event (stroke, TIA) within the past 3 months Active endocarditis or history of mitral/tricuspid endocarditis within the last 12 months Patient has significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis) Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count <90k) 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 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 Patients unsuitable for implantation because of thrombosis of the lower venous system or presence of a vena cava filter The patient has contraindication against a transesophageal echo (TEE) during the procedure Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days) Hepatic insufficiency (MELD > 10) Female patient of child-bearing potential Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol Requirement for Antibiotic Treatment within the last 48 hours Cardiac Anatomy deemed not suitable for the Cardiovalve Implant Surgical or interventional procedure planned within 30 days prior to index procedure UNOS Status 1 heart transplant or prior orthotropic heart transplantation. Any prior Tricuspid valve surgery or transcatheter Tricuspid valve procedure Modified Rankin Scale > 4 disability Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of index procedure Currently participating in an investigational drug or another device study which has not reached its primary endpoint Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment Chronic oral steroid or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease). Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope ) at the time of screening Severe COPD or continuous use of home oxygen 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 Aortic or pulmonic valve disease requiring surgery Venous peripheral anatomy unsuitable for implant delivery Chronic anemia (Hgb < 9)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Baker, PhD
Phone
(508) 351-8632
Email
lbaker@boston-biomedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Pierce, MS
Phone
(508) 351-8632
Email
kpierce@boston-biomedical.com
Facility Information:
Facility Name
Northwestern University / Bluhm Cardiovascular Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azeem Latib, MD
Facility Name
Columbia University Medical Center / NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamim Nazif, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation

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