Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

Mitral Valve Insufficiency Clinical Trial

Official title:

Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01533883
• Other study ID #: CB1-1
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2012
• Last updated: August 28, 2016
• Start date: September 2011
• Est. completion date: June 2018

Study information

• Verified date: August 2016
• Source: Valtech Cardio Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthGermany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. The aim of this study is to evaluate the performance and safety of the Cardioband for repair of mitral regurgitation.

Description:

The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are reserved to fit patients with low or moderate surgical risk, and thus several patients are refused surgery because of unfavorable risk-benefit balance. Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. Cardioband is intended to remodel the annulus by deployment and fixation along (and direct) the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 = 70mm

• Subject is high risk to undergo MV surgery (as assessed by a cardiac surgeon and a cardiologist at the site, and according to ESC/EACTS guidelines on the management of valvular heart disease)

• 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 requiband revascularization

• 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 requiband dialysis

• Life expectancy of less than twelve months

• Patient is pregnant (urine HCG test result positive) or lactating

• Known sensitivity to Nickel or Chromium

• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically

• Bleeding or clotting disorders

• Subject is participating in concomitant research studies of investigational products

• Pulmonary hypertension >70mmHg at rest

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• Cardioband adjustable band
Cardioband is an adjustable sutureless annuloplasty band designed for mitral valve repair by a transfemoral approach. Cardioband is intended to remodel the annulus by deployment and fixation along the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.

Locations

Country	Name	City	State
Italy	Ospedale Ferrarotto Alessi	Catania
Italy	Hospital san raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Valtech Cardio Ltd

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety	Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE) until hospital discharge and at post-operative 30 days.	30 days	Yes
Primary	Technical success rate of the implantation of the Cardioband		Immedietly after implantation	No
Primary	Technical feasibility of Cardioband adjustment		Immedietly after procedure	No
Primary	Reduce MR	Cardioband ability to reduce mitral valve regurgitation (MR) post-procedure, at post-operative hospital discharge, and at post-operative 30 days.	30 days	Yes
Secondary	safety	Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE)will be compared to the literature.	12 months	Yes
Secondary	Performance	Change in MR severity in 6 and 12 months	6 and 12 months	No
Secondary	Performance	Change in 6 MWT in 6 and 12 months	6 and 12 months	No
Secondary	Performance	Change in quality of life questionnaire (MLHFQ) in 6 and 12 months	6 and 12 months	No