Cardiovalve Transfemoral System - FIM Study
Primary Purpose
Mitral Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Cardiovalve transfemoral Mitral valve system
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation focused on measuring Mitral valve, Functional mitral regurgitation, Heart failure
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- NYHA functional II, III or ambulatory IV
- Severe mitral regurgitation (MR grade 3-4+)
- High 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)
- Able to undergo Transesophageal Echocardiography (TEE).
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
- The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
- Suitable for femoral access procedure and transseptal catheterization
- Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve
Exclusion Criteria:
- Prior stroke or TIA within 3 months
- Acute myocardial infarction within the previous 30 days
- Any prior heart valve surgery or transcatheter mitral intervention
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
- Rheumatic heart disease or endocarditis within the previous 3 months
- 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
- Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
- Untreated clinically significant coronary artery disease requiring revascularization
- Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
- Aortic valve disease requiring surgery Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
- Left Ventricular Ejection Fraction ( LVEF) <30%
- LV end diastolic diameter > 70mm
- Significant abnormalities of the mitral valve and sub-valvular apparatus.
- Severe mitral annular or leaflets calcification
- Left atrial or LV thrombus
- Severe right ventricular dysfunction
- Severe tricuspid or aortic valve disease General Exclusion Criteria
- Subject who is currently participating in an investigational study, other than this study
- 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
- 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
- Bleeding diathesis or hypercoagulable state
- Active peptic ulcer or active gastrointestinal bleeding
- Pulmonary artery systolic pressure >70 mmHg
- Patients with renal insufficiency (creatinine > 2.5 mg/dL)
- Subject with hepatic insufficiency
- Subject has a co-morbid illness that may result in a life expectancy of less than one year
- Active infection that requires antibiotic therapy
- Subject is pregnant, breastfeeding or intend to become pregnant within one year
Sites / Locations
- Hospital of the Lithuanian University of Health Sciences ligoninė KaunoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiovalve treatment
Arm Description
Patients that implanted with the Cardiovalve device
Outcomes
Primary Outcome Measures
Freedom from major device or procedure related serious adverse events
Freedom from major device or procedure related serious adverse events:
F. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h.
I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Secondary Outcome Measures
Technical success
Technical success; delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis, LVOT obstruction or paravalvular MR documented by intraoperative imaging Number of patients for whom the device was successfully implanted (per MVARC definitions) Number of patients with reduction in MR grade from Baseline Number of patients with improvement in NYHA class from baseline Number of patients with increase distance walked in the 6MW test from baseline.
Full Information
NCT ID
NCT03958773
First Posted
May 19, 2019
Last Updated
July 28, 2022
Sponsor
Cardiovalve Ltd.
Collaborators
Meditrial Europe Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03958773
Brief Title
Cardiovalve Transfemoral System - FIM Study
Official Title
Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiovalve Ltd.
Collaborators
Meditrial Europe Ltd.
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
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
Detailed Description
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
The purpose of this study is to evaluate the safety of the CardiovalveSystem with its associated procedure, and observe the device performance in reducing mitral regurgitation Data collected in this 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 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
Keywords
Mitral valve, Functional mitral regurgitation, Heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-center, single-arm feasibility clinical study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiovalve treatment
Arm Type
Experimental
Arm Description
Patients that implanted with the Cardiovalve device
Intervention Type
Device
Intervention Name(s)
Cardiovalve transfemoral Mitral valve system
Intervention Description
Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.
Primary Outcome Measure Information:
Title
Freedom from major device or procedure related serious adverse events
Description
Freedom from major device or procedure related serious adverse events:
F. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h.
I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success; delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis, LVOT obstruction or paravalvular MR documented by intraoperative imaging Number of patients for whom the device was successfully implanted (per MVARC definitions) Number of patients with reduction in MR grade from Baseline Number of patients with improvement in NYHA class from baseline Number of patients with increase distance walked in the 6MW test from baseline.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
NYHA functional II, III or ambulatory IV
Severe mitral regurgitation (MR grade 3-4+)
High 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)
Able to undergo Transesophageal Echocardiography (TEE).
Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
Suitable for femoral access procedure and transseptal catheterization
Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve
Exclusion Criteria:
Prior stroke or TIA within 3 months
Acute myocardial infarction within the previous 30 days
Any prior heart valve surgery or transcatheter mitral intervention
Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
Rheumatic heart disease or endocarditis within the previous 3 months
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
Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
Untreated clinically significant coronary artery disease requiring revascularization
Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
Aortic valve disease requiring surgery Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
Left Ventricular Ejection Fraction ( LVEF) <30%
LV end diastolic diameter > 70mm
Significant abnormalities of the mitral valve and sub-valvular apparatus.
Severe mitral annular or leaflets calcification
Left atrial or LV thrombus
Severe right ventricular dysfunction
Severe tricuspid or aortic valve disease General Exclusion Criteria
Subject who is currently participating in an investigational study, other than this study
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
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
Bleeding diathesis or hypercoagulable state
Active peptic ulcer or active gastrointestinal bleeding
Pulmonary artery systolic pressure >70 mmHg
Patients with renal insufficiency (creatinine > 2.5 mg/dL)
Subject with hepatic insufficiency
Subject has a co-morbid illness that may result in a life expectancy of less than one year
Active infection that requires antibiotic therapy
Subject is pregnant, breastfeeding or intend to become pregnant within one year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitza Shoham, PhD
Phone
+972765388142
Ext
8142
Email
nitza@cardiovalve.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ronit Pick
Email
ronit@cardiovalve.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rimantas Benetis, MD
Organizational Affiliation
Head of department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the Lithuanian University of Health Sciences ligoninė Kauno
City
Kaunas
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rimantas Benetis, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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