We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardioband With Transfemoral Delivery System

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01841554
First Posted: April 26, 2013
Last Update Posted: August 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valtech Cardio Ltd
April 23, 2013
April 26, 2013
August 30, 2016
April 2013
July 2016   (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 ]

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 ]
  • 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 ]
  • 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mitral Regurgitation
Device: Cardioband
Other Name: With Transfemoral delivery system
Experimental: Single
Intervention: Device: Cardioband

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
51
Not Provided
July 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Netherlands,   Switzerland
 
 
NCT01841554
CB1-2
Yes
Not Provided
Not Provided
Valtech Cardio Ltd
Valtech Cardio Ltd
Not Provided
Not Provided
Valtech Cardio Ltd
August 2016

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