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VenTouch OUS Feasibility Study

Primary Purpose

Functional Mitral Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VenTouch System
Sponsored by
Mardil Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults ≥18 years of age
  2. Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2)
  3. NYHA Class II to IV
  4. Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography
  5. Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days
  6. Subjects with a Class I indication for CRT implant according to current guidelines should have CRT implant prior to entry into the study. Subjects who have existing CRT implants may be included in the study if the implant has been in place for at least 90 days; reprogramming of an implanted CRT that results in increased biventricular pacing (from <92% to ≥92%) must be in place for at least 30 days.
  7. Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography
  8. Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA))
  9. Subject is willing and available to return for study follow-up
  10. Subject or legal representative understands and provides signed informed consent for participation in study
  11. Acceptance of subject for trial enrollment after review of all subject baseline data by Study Selection Committee

Exclusion Criteria:

  1. Life expectancy of less than 12 months due to conditions other than cardiac status
  2. Anticipated need for LVAD or transplant within 12 months
  3. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
  4. American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure
  5. Six-minute walk distance < 150 meters
  6. Identified need for any cardiovascular surgery
  7. STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee
  8. Untreated clinically significant coronary artery disease
  9. Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads, pericarditis, or other procedure involving pericardial access)
  10. Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI myocardial infarction, unstable angina) or clinically significant cardiac events (e.g. hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any hospitalization) within 30 days of enrollment
  11. Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
  12. Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion)
  13. Severe symptomatic carotid stenosis
  14. Severe or sustained pulmonary hypertension, defined by resting pulmonary artery systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart catheterization
  15. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction or moderate to severe TR
  16. Hypotension (systolic pressure <90 mmHg)
  17. Hemodynamic instability requiring inotropic support or mechanical heart assistance within 30 days
  18. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart disease causing heart failure other than dilated cardiomyopathy
  19. UNOS status 1 heart transplantation
  20. Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis
  21. Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of enrollment
  22. Active systemic infection or bleeding
  23. Autoimmune disorders and/or the use of immune suppression therapy
  24. Females who are pregnant (as documented by HCG beta pregnancy test in females of child-bearing age) or lactating
  25. Currently enrolled in another investigational drug or device study

Intra-Operative Exclusion Criteria:

  1. Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion)
  2. Signs/indications of ischemia
  3. Intra-operative coronary angiography demonstrates that there is compression of the coronary arteries or reduction in coronary blood flow due to the VenTouch implant

Sites / Locations

  • Libin Cardiovascular Institute, University of Calgary
  • University of British Columbia, St. Paul's Hospital
  • London Health Sciences Centre, University Hospital
  • Toronto General HospitalRecruiting
  • Montreal Heart InstituteRecruiting
  • Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ)Recruiting
  • Bordeaux Heart University Hospital
  • CardioVasculäres Centrum
  • Semmelweis University Heart and Vascular CenterRecruiting
  • Leiden University Medical Center
  • Pacifica Salud Hospital Punta PacificaRecruiting
  • Centralny Szpital Kliniczny MSWiA w Warszawia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VenTouch System Implant

Arm Description

The VenTouch System is intended for use in the treatment of functional MR (FMR) in adults who are symptomatic despite optimal medical management. It is indicated for subjects with FMR with essentially normal leaflet anatomy and motion, with mitral valve regurgitation attributable to annular and/or ventricular dilation. It is not intended to treat structural defects/degeneration of the mitral valve. The VenTouch System is intended to provide ventricular support that will encourage beneficial remodeling of the heart and, with adjustable inflatable chambers, it is intended to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation, allowing proper closure of the valve, and reducing or eliminating MR. The VenTouch System is indicated for patients who have "moderately severe" or "severe" mitral regurgitation (grade 3 or 4 MR).

Outcomes

Primary Outcome Measures

Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures and intraoperative transesophageal echocardiographic (TEE) evidence of MR severity reduction (a minimum of one grade)
Evaluate SAE Rates
Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment

Secondary Outcome Measures

Evaluate SAE Rates
Evaluate Serious Adverse Event (SAE) rates
Evaluate MR Severity
Evaluate MR severity reduction and mitral valve dimension reduction via echocardiographic core lab assessment
Evaluate Reverse Ventricular Remodeling
Evaluate reverse ventricular remodeling via echocardiographic core lab assessment
Evaluate Changes in Patient Symptoms by NYHA
Evaluate changes in patient symptoms as assessed by the NYHA functional class
Evaluate Changes in Patient Functional Status by Six-Minute Walk
Evaluate changes in patient functional status as assessed by Six-Minute Walk
Evaluate Changes in Patient Functional Status by KCCQ
Evaluate changes in patient functional status as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Full Information

First Posted
July 24, 2018
Last Updated
September 8, 2020
Sponsor
Mardil Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03616678
Brief Title
VenTouch OUS Feasibility Study
Official Title
Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mardil Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.
Detailed Description
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR enrolling up to 15 subjects who have been diagnosed with Grade 3-4 functional mitral valve regurgitation and deemed eligible per assessment by the inclusion/exclusion criteria. The duration of the study follow-up is 36 months from the time of therapy adjustment. Data from this trial may be utilized in support of a CE study in Europe and/or a pilot IDE study in the U.S. Follow-up testing will be performed at 1, 3, 6, 12, 24, and 36 months post-therapy adjustment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral 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
VenTouch System Implant
Arm Type
Experimental
Arm Description
The VenTouch System is intended for use in the treatment of functional MR (FMR) in adults who are symptomatic despite optimal medical management. It is indicated for subjects with FMR with essentially normal leaflet anatomy and motion, with mitral valve regurgitation attributable to annular and/or ventricular dilation. It is not intended to treat structural defects/degeneration of the mitral valve. The VenTouch System is intended to provide ventricular support that will encourage beneficial remodeling of the heart and, with adjustable inflatable chambers, it is intended to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation, allowing proper closure of the valve, and reducing or eliminating MR. The VenTouch System is indicated for patients who have "moderately severe" or "severe" mitral regurgitation (grade 3 or 4 MR).
Intervention Type
Device
Intervention Name(s)
VenTouch System
Intervention Description
The VenTouch™ System consists of a delivery tool with a pre-loaded implant (VenTouch device) and accessories, which include a sizing tool, PEMS, chamber positioning tool, and accessories kit with luer fitting, tubing clamp, and titanium plug. The VenTouch device is offered in 6 sizes, with 4 different sized inflatable chambers available. Please refer to the VenTouch Instructions for Use for and system details. The VenTouch device consists of three (3) inflatable silicone chambers attached to the wall of a knitted polyester support. The VenTouch device is implanted around the base of the heart and positioned at the level of the atrio-ventricular (AV) groove and the adjacent ventricular muscle. The VenTouch device is composed of biocompatible, medical-grade silicone and polyester.
Primary Outcome Measure Information:
Title
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures
Description
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures and intraoperative transesophageal echocardiographic (TEE) evidence of MR severity reduction (a minimum of one grade)
Time Frame
Intra-operative
Title
Evaluate SAE Rates
Description
Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Evaluate SAE Rates
Description
Evaluate Serious Adverse Event (SAE) rates
Time Frame
36 Months
Title
Evaluate MR Severity
Description
Evaluate MR severity reduction and mitral valve dimension reduction via echocardiographic core lab assessment
Time Frame
36 Months
Title
Evaluate Reverse Ventricular Remodeling
Description
Evaluate reverse ventricular remodeling via echocardiographic core lab assessment
Time Frame
36 Months
Title
Evaluate Changes in Patient Symptoms by NYHA
Description
Evaluate changes in patient symptoms as assessed by the NYHA functional class
Time Frame
36 Months
Title
Evaluate Changes in Patient Functional Status by Six-Minute Walk
Description
Evaluate changes in patient functional status as assessed by Six-Minute Walk
Time Frame
36 Months
Title
Evaluate Changes in Patient Functional Status by KCCQ
Description
Evaluate changes in patient functional status as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame
36 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults ≥18 years of age Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2) NYHA Class II to IV Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days Subjects with a Class I indication for CRT implant according to current guidelines should have CRT implant prior to entry into the study. Subjects who have existing CRT implants may be included in the study if the implant has been in place for at least 90 days; reprogramming of an implanted CRT that results in increased biventricular pacing (from <92% to ≥92%) must be in place for at least 30 days. Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA)) Subject is willing and available to return for study follow-up Subject or legal representative understands and provides signed informed consent for participation in study Acceptance of subject for trial enrollment after review of all subject baseline data by Study Selection Committee Exclusion Criteria: Life expectancy of less than 12 months due to conditions other than cardiac status Anticipated need for LVAD or transplant within 12 months Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure Six-minute walk distance < 150 meters Identified need for any cardiovascular surgery STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee Untreated clinically significant coronary artery disease Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads, pericarditis, or other procedure involving pericardial access) Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI myocardial infarction, unstable angina) or clinically significant cardiac events (e.g. hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any hospitalization) within 30 days of enrollment Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis) Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion) Severe symptomatic carotid stenosis Severe or sustained pulmonary hypertension, defined by resting pulmonary artery systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart catheterization Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction or moderate to severe TR Hypotension (systolic pressure <90 mmHg) Hemodynamic instability requiring inotropic support or mechanical heart assistance within 30 days Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart disease causing heart failure other than dilated cardiomyopathy UNOS status 1 heart transplantation Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of enrollment Active systemic infection or bleeding Autoimmune disorders and/or the use of immune suppression therapy Females who are pregnant (as documented by HCG beta pregnancy test in females of child-bearing age) or lactating Currently enrolled in another investigational drug or device study Intra-Operative Exclusion Criteria: Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion) Signs/indications of ischemia Intra-operative coronary angiography demonstrates that there is compression of the coronary arteries or reduction in coronary blood flow due to the VenTouch implant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hase, BS
Phone
763-710-4518
Email
shase@mardil.com
Facility Information:
Facility Name
Libin Cardiovascular Institute, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Kent, MD
Phone
403-944-5480
Email
william.kent@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
William Kent, MD
Facility Name
University of British Columbia, St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherin Mok
Phone
604-806-8383
Email
CMok@providencehealth.bc.ca
First Name & Middle Initial & Last Name & Degree
Anson Cheung, MD
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Fox, BA, RRT
Phone
519-685-8500
Ext
35031
Email
Stephanie.Fox@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Dave Nagpal, MD
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
4NU-470
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shakira Christie
Email
Shakira.Christie@uhn.ca
First Name & Middle Initial & Last Name & Degree
Vivek Rao, MD, PhD
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Vervais
Phone
514-376-3330
Ext
3783
Email
manon.vervais@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Anita Asgar, MD
First Name & Middle Initial & Last Name & Degree
Denis Bouchard, MD
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ)
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Tremblay
Phone
418-656-8711
Ext
3797
Email
hugo.tremblay@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
François Dagenais, MD
Facility Name
Bordeaux Heart University Hospital
City
Bordeaux
State/Province
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Withdrawn
Facility Name
CardioVasculäres Centrum
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Semmelweis University Heart and Vascular Center
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orsolya Kemenes
Phone
+36 20 8250511
Email
studycenter.sekk@gmail.com
First Name & Middle Initial & Last Name & Degree
Béla Merkely, MD, PhD
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Pacifica Salud Hospital Punta Pacifica
City
Panama City
ZIP/Postal Code
0801
Country
Panama
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margelis Muñoz
Phone
(507) 6499-9304
Email
margelismunoz@gmail.com
First Name & Middle Initial & Last Name & Degree
Christian Marin y Kall
Phone
305-799-1435
Email
marinykallch@hotmail.com
First Name & Middle Initial & Last Name & Degree
Manuel Ochoa, MD
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawia
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.mardil.com
Description
Study Sponsor Website

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VenTouch OUS Feasibility Study

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