V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Valtech Cardio Ltd.
Recruitment status was  Active, not recruiting
Sponsor:
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
  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:

    1. Anchor the system in the papillary muscle;
    2. Suture the leaflet;
    3. Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue.
    4. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415947

Locations
Italy
HSR
Milano, Italy, 20132
Sponsors and Collaborators
Valtech Cardio Ltd
Investigators
Principal Investigator: Ottavio Alfiieri, MD Hospital San Raffaele
  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 July 20, 2014