Cardioband With Transfemoral Delivery System

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Valtech Cardio Ltd
Sponsor:
Information provided by (Responsible Party):
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01841554
First received: April 23, 2013
Last updated: June 14, 2015
Last verified: June 2015

April 23, 2013
June 14, 2015
April 2013
October 2015   (final data collection date for primary outcome measure)
Safety • Overall rate of Major Serious Adverse Events (SAEs) and serious adverse safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Overall rate of Major Serious Adverse Events (SAEs)* and serious adverse device effects (SADE) until hospital discharge and at post-operative 30 days.

* Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke

Same as current
Complete list of historical versions of study NCT01841554 on ClinicalTrials.gov Archive Site
Performance [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • MR Severity at 6 and 12 months
  • Change in 6 MWT in 6 and 12 months
  • Change in quality of life (MLHFQ) at 6 and 12 months
Same as current
Performance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Technical success rate of the implantation of the Cardioband
  • Technical feasibility of Cardioband adjustment
  • Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days.
Same as current
 
Cardioband With Transfemoral Delivery System
Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mitral Regurgitation
Device: Cardioband
Other Name: With Transfemoral delivery system
Experimental: Single
Intervention: Device: Cardioband
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
Not Provided
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Moderate to severe functional MR
  • Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including CRT if indicated.
  • LVEF ≥ 25%, LVEDD ≤ 65mm
  • Subject is high risk to undergo MV surgery (as assessed by a surgeon and a cardiologist, at the site)
  • Transseptal catheterization and femoral vein access is determined to be feasible
  • Subject is able and willing to give informed consent and follow protocol procedures

Exclusion Criteria:

  • Active bacterial endocarditis
  • Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
  • Heavily calcified annulus or leaflets
  • Subjects in whom transesophageal echocardiography is contraindicated
  • Untreated clinically significant CAD requiring revascularization
  • CRT implant within 3 months prior to procedure
  • Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
  • CVA or TIA within 6 months or severe carotid stenosis (>70% by Ultra sound)
  • Renal insufficiency requiring dialysis
  • Life expectancy of less than twelve months
  • Subject is participating in concomitant research studies of investigational products
  • Mitral valve anatomy which may preclude proper device treatment
  • Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation
Both
18 Years and older
No
France,   Germany,   Netherlands,   Switzerland
 
NCT01841554
CB1-2
Yes
Valtech Cardio Ltd
Valtech Cardio Ltd
Not Provided
Not Provided
Valtech Cardio Ltd
June 2015

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