Completed

Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

What is being tested

Cardioband

Device

Who is being recruted

Cardiovascular Diseases+1

+ Heart Diseases

+ Heart Valve Diseases

Over 18 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: September 2011

See protocol details

Summary

Principal SponsorEdwards Lifesciences

Last updated: November 30, 2020

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

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

NCT01841554 NCT01533883

Principal SponsorEdwards Lifesciences

Last updated: November 30, 2020

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Valve DiseasesMitral Valve Insufficiency

Criteria

7 inclusion criteria required to participate

Age > 18 years

Left Ventricle Ejection Fraction (LVEF) >= 25%, LVEDD <= 65mm

Moderate to severe functional Mitral Regurgitation (MR)

Subject is able and willing to give informed consent and follow protocol procedures

Show More Criteria

13 exclusion criteria prevent from participating

Active bacterial endocarditis

Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months

CRT implant within 3 months prior to procedure

Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis ( > 70% by Ultra sound)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Hôpital Bichat-Claude Bernard

Paris, FranceOpen Hôpital Bichat-Claude Bernard in Google Maps

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II

Bonn, Germany

Universitätskliniken zu Köln Klinik III Innere Medizin

Cologne, Germany

Asklepios Klinik, St. Georg

Hamburg, Germany

Completed11 Study Centers