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Cardioband With Transfemoral Delivery System

Primary Purpose

Mitral Regurgitation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardioband
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Regurgitation focused on measuring Mitral Valve, Annuloplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • Moderate to severe functional Mitral Regurgitation (MR)
  • Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated.
  • Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm
  • Subject is high risk to undergo Mitral Valve (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 Coronary Artery Disease (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
  • Cerebrovascular Accident (CVA) or Transient Ischemic Attack (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

Sites / Locations

  • Hôpital Bichat-Claude Bernard
  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
  • Asklepios Klinik, St. Georg
  • Universitätskliniken zu Köln Klinik III Innere Medizin
  • Zentrum für Kardiologie, Universitätsmedizin Mainz
  • Munich University Clinic
  • Rambam Cardiology Research Unit
  • Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
  • San Raffaele University Hospital
  • St.Antonius Ziekenhuis
  • UniversitätsSpital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.

Secondary Outcome Measures

Performance [6MWT]
Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.
Performance [MLHFQ]
Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.
Performance [Intra-subject Comparison - MR Severity]
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Performance [Full Analysis Data Set - MR Severity]
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).

Full Information

First Posted
April 23, 2013
Last Updated
November 26, 2020
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT01841554
Brief Title
Cardioband With Transfemoral Delivery System
Official Title
Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
Keywords
Mitral Valve, Annuloplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cardioband
Other Intervention Name(s)
With Transfemoral delivery system
Primary Outcome Measure Information:
Title
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Description
Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Performance [6MWT]
Description
Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.
Time Frame
Baseline, 6 and 12 months
Title
Performance [MLHFQ]
Description
Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.
Time Frame
Baseline, 6 and 12 months
Title
Performance [Intra-subject Comparison - MR Severity]
Description
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Time Frame
Baseline, discharge, 6 and 12 months
Title
Performance [Full Analysis Data Set - MR Severity]
Description
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Time Frame
Baseline, discharge, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Reduce MR [Paired Baseline and Follow-Up]
Description
Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.
Time Frame
Post-adjustment, discharge, and 30 Days
Title
Technical Feasibility of Cardioband Adjustment
Description
The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.
Time Frame
Immediately after procedure
Title
Technical Success Rate of the Implantation of the Cardioband
Description
The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.
Time Frame
Immediately after implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Moderate to severe functional Mitral Regurgitation (MR) Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated. Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm Subject is high risk to undergo Mitral Valve (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 Coronary Artery Disease (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 Cerebrovascular Accident (CVA) or Transient Ischemic Attack (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Maisano, Prof.
Organizational Affiliation
Universitätsspital Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Asklepios Klinik, St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitätskliniken zu Köln Klinik III Innere Medizin
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Zentrum für Kardiologie, Universitätsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Munich University Clinic
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Rambam Cardiology Research Unit
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
San Raffaele University Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
St.Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
UniversitätsSpital Zürich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25326746
Citation
Maisano F, La Canna G, Latib A, Denti P, Taramasso M, Kuck KH, Colombo A, Alfieri O, Guidotti A, Messika-Zeitoun D, Vahanian A. First-in-man transseptal implantation of a "surgical-like" mitral valve annuloplasty device for functional mitral regurgitation. JACC Cardiovasc Interv. 2014 Nov;7(11):1326-8. doi: 10.1016/j.jcin.2014.08.003. Epub 2014 Oct 15. No abstract available.
Results Reference
background
PubMed Identifier
26586779
Citation
Maisano F, Taramasso M, Nickenig G, Hammerstingl C, Vahanian A, Messika-Zeitoun D, Baldus S, Huntgeburth M, Alfieri O, Colombo A, La Canna G, Agricola E, Zuber M, Tanner FC, Topilsky Y, Kreidel F, Kuck KH. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur Heart J. 2016 Mar 7;37(10):817-25. doi: 10.1093/eurheartj/ehv603. Epub 2015 Nov 18.
Results Reference
background
PubMed Identifier
30124798
Citation
Messika-Zeitoun D, Nickenig G, Latib A, Kuck KH, Baldus S, Schueler R, La Canna G, Agricola E, Kreidel F, Huntgeburth M, Zuber M, Verta P, Grayburn P, Vahanian A, Maisano F. Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. Eur Heart J. 2019 Feb 1;40(5):466-472. doi: 10.1093/eurheartj/ehy424.
Results Reference
derived
PubMed Identifier
27712741
Citation
Nickenig G, Hammerstingl C, Schueler R, Topilsky Y, Grayburn PA, Vahanian A, Messika-Zeitoun D, Urena Alcazar M, Baldus S, Volker R, Huntgeburth M, Alfieri O, Latib A, La Canna G, Agricola E, Colombo A, Kuck KH, Kreidel F, Frerker C, Tanner FC, Ben-Yehuda O, Maisano F. Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2039-2047. doi: 10.1016/j.jcin.2016.07.005.
Results Reference
derived

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Cardioband With Transfemoral Delivery System

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