V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
This study is ongoing, but not recruiting participants.
Sponsor:
Valtech Cardio Ltd
Information provided by (Responsible Party):
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01415947
First received: August 10, 2011
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mitral Leaflet Prolapse |
Device: V Chordal |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse |
Resource links provided by NLM:
Further study details as provided by Valtech Cardio Ltd:
Primary Outcome Measures:
- Technical success rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]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). [ Time Frame: 30 days, and 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Valtech Cardio Ltd |
| ClinicalTrials.gov Identifier: | NCT01415947 History of Changes |
| Other Study ID Numbers: | CH1-1 |
| Study First Received: | August 10, 2011 |
| Last Updated: | June 20, 2012 |
| Health Authority: | Italy: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic |
Keywords provided by Valtech Cardio Ltd:
|
Heart disease Device Mitral valve leaflet prolapse |
Heart valve disease Cardiovascular disease Neochordae |
Additional relevant MeSH terms:
|
Mitral Valve Insufficiency Mitral Valve Prolapse Neurocirculatory Asthenia Orthostatic Intolerance Prolapse Heart Valve Diseases Heart Diseases Cardiovascular Diseases Heart Valve Prolapse |
Anxiety Disorders Mental Disorders Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013