V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
This study has been terminated.
(Company business decision)
Information provided by (Responsible Party):
Valtech Cardio Ltd
First received: August 10, 2011
Last updated: December 22, 2014
Last verified: December 2014
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.
Mitral Leaflet Prolapse
Device: V Chordal
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Primary Outcome Measures:
Secondary Outcome Measures:
- Incidence of Major Adverse Events (MAE). [ Time Frame: 30 days, and 6 months ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
Device: V Chordal
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01415947
Valtech Cardio Ltd
||Ottavio Alfiieri, MD
||Hospital San Raffaele
No publications provided
||Valtech Cardio Ltd
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 10, 2011
||December 22, 2014
||Italy: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Valtech Cardio Ltd:
Heart valve disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Mitral Valve Insufficiency
Mitral Valve Prolapse
Autonomic Nervous System Diseases
Heart Valve Diseases
Heart Valve Prolapse
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms