Back to resultsV-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Primary Purpose
Mitral Leaflet Prolapse
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
V Chordal
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Leaflet Prolapse focused on measuring Heart disease, Device, Mitral valve, leaflet prolapse, Heart valve disease, Cardiovascular disease, Neochordae
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
- Patient able and willing to return to the implant center for follow-up visits
- Able and willing to give informed consent and follow protocol procedures.
Exclusion Criteria:
- Inadequate echocardiographic window for transthoracic imaging
- Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
- Evolving endocarditis or active endocarditis in the last 3 months.
- Heavily calcified annulus or leaflets.
- Congenital malformation with limited valvular tissue
- Patient requires mitral valve replacement.
- Previously implanted annuloplasty ring/band.
- Patient requires aortic or pulmonic valve replacement or repair.
- Patient is pregnant (urine HCG test result positive) or lactating.
- Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
- Life expectancy of less than twelve months.
- Patient is participating in concomitant research studies of investigational products.
Sites / Locations
- HSR
Outcomes
Primary Outcome Measures
Technical success rate
ability to:
Anchor the system in the papillary muscle;
Suture the leaflet;
Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue.
Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB
Efficacy
The ability of the V-Chordal System to correct leaflet prolapse of the treated segments as assessed by echordiography. Correction is defined as leaflet displacement <2 mm above the annulus in the septolateral view.
Secondary Outcome Measures
Incidence of Major Adverse Events (MAE).
Full Information
NCT ID
NCT01415947
First Posted
August 10, 2011
Last Updated
December 22, 2014
Sponsor
Edwards Lifesciences
1. Study Identification
Unique Protocol Identification Number
NCT01415947
Brief Title
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Official Title
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Company business decision
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
5. Study Description
Brief Summary
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Leaflet Prolapse
Keywords
Heart disease, Device, Mitral valve, leaflet prolapse, Heart valve disease, Cardiovascular disease, Neochordae
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
V Chordal
Intervention Description
V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" . The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
Primary Outcome Measure Information:
Title
Technical success rate
Description
ability to:
Anchor the system in the papillary muscle;
Suture the leaflet;
Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue.
Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB
Time Frame
6 months
Title
Efficacy
Description
The ability of the V-Chordal System to correct leaflet prolapse of the treated segments as assessed by echordiography. Correction is defined as leaflet displacement <2 mm above the annulus in the septolateral view.
Time Frame
30 days and 6 months
Secondary Outcome Measure Information:
Title
Incidence of Major Adverse Events (MAE).
Time Frame
30 days, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
Patient able and willing to return to the implant center for follow-up visits
Able and willing to give informed consent and follow protocol procedures.
Exclusion Criteria:
Inadequate echocardiographic window for transthoracic imaging
Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
Evolving endocarditis or active endocarditis in the last 3 months.
Heavily calcified annulus or leaflets.
Congenital malformation with limited valvular tissue
Patient requires mitral valve replacement.
Previously implanted annuloplasty ring/band.
Patient requires aortic or pulmonic valve replacement or repair.
Patient is pregnant (urine HCG test result positive) or lactating.
Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
Life expectancy of less than twelve months.
Patient is participating in concomitant research studies of investigational products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ottavio Alfiieri, MD
Organizational Affiliation
Hospital San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
HSR
City
Milano
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
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