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出境医 / 临床实验 / Cardiovalve Transfemoral System - FIM Study

Cardiovalve Transfemoral System - FIM Study

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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: Cardiovalve transfemoral Mitral valve system Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-center, single-arm feasibility clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Cardiovalve treatment
Patients that implanted with the Cardiovalve device
 Device: Cardiovalve transfemoral Mitral valve system
Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.
Outcome Measures
Primary Outcome Measures :
  1. Freedom from major device or procedure related serious adverse events [ Time Frame: 30 days ]

    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 :
  1. Technical success [ Time Frame: Intraoperative ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Nitza Shoham, PhD +972765388142 ext 8142 nitza@cardiovalve.com
Contact: Ronit Pick ronit@cardiovalve.com

Locations
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Lithuania
Hospital of the Lithuanian University of Health Sciences ligoninė Kauno Recruiting
Kaunas, Lithuania
Contact: Rimantas Benetis, MD         
Sponsors and Collaborators
Cardiovalve Ltd.
Meditrial Europe Ltd.
Investigators
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Principal Investigator: Rimantas Benetis, MD Head of department
Tracking Information
First Submitted Date  ICMJE May 19, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE October 12, 2017
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2019) 		Freedom from major device or procedure related serious adverse events [ Time Frame: 30 days ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2021) 		Technical success [ Time Frame: Intraoperative ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2019) 		Technical success [ Time Frame: Intraoperative ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovalve Transfemoral System - FIM Study
Official Title  ICMJE Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, single-center, single-arm feasibility clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Regurgitation
Intervention  ICMJE Device: Cardiovalve transfemoral Mitral valve system
Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.
Study Arms  ICMJE Experimental: Cardiovalve treatment
Patients that implanted with the Cardiovalve device
Intervention: Device: Cardiovalve transfemoral Mitral valve system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2024
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nitza Shoham, PhD +972765388142 ext 8142 nitza@cardiovalve.com
Contact: Ronit Pick ronit@cardiovalve.com
Listed Location Countries  ICMJE Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958773
Other Study ID Numbers  ICMJE CP 17-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cardiovalve Ltd.
Study Sponsor  ICMJE Cardiovalve Ltd.
Collaborators  ICMJE Meditrial Europe Ltd.
Investigators  ICMJE
Principal Investigator: Rimantas Benetis, MD Head of department
PRS Account Cardiovalve Ltd.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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