A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

NCT01772108 | Terminated DMC

• 1 other identifier: 12-513
• Study Type: interventional
• Target: 42
• Locations: 10 countries
• Sites: 29

Brief Summary

This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.

Conditions

Cardiovascular Diseases

Keywords

Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations

  The analysis will be carried out when the last patient completes 12-month follow-up. All follow-up, up to 24 months, will be included in the analysis.

  two years

Secondary Outcomes (7)

• Composite of all-cause mortality, stroke, myocardial infarction, new need for renal replacement therapy, and non-elective cardiovascular surgery for device related complications in the Device group at 30 days

  30 days

• Mitral regurgitation severity reduction to mild or mild-to-moderate at 12 months

  12 months

• Change in Left Ventricular End Diastolic Volume (LVEDV) at 12 months over baseline

  12 months

• Change in Left Ventricular End Systolic Volume (LVESV) at 12 months over baseline

  12 months

• Change in 6 Minute Walk Test (6MWT) distance at 12 months over baseline

  12 months

Study Arms (2)

MitraClip Device

EXPERIMENTAL

Subjects randomized to the Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.

Device: MitraClip

Control

NO INTERVENTION

Subjects randomized to the Control group will receive optimal standard of care therapy alone.

Interventions

MitraClip DEVICE

The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets

MitraClip Device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 years and 90 years old
• Clinically significant functional mitral regurgitation (moderate-to-severe or severe mitral regurgitation), as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory
• Assessed by the investigator to be on optimal standard of care therapy for heart failure for at least 4 weeks with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization
• Documented New York Heart Association Class III or Class IV heart failure, despite optimal standard of care therapy, within 90 days preceding randomization
• Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of at least 350 pg/mL for BNP or at least 1400 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization
• Left ventricular ejection fraction (LVEF) ≥15% and ≤40% determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory
• Left ventricular end diastolic diameter (LVEDD) ≥55 mm determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory
• Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness
• Subject agrees to return for all required post-procedure follow-up visits
• The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee

You may not qualify if:

• Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative mitral regurgitation), as determined by transesophageal echocardiography
• Status 1 heart transplant or prior orthotopic heart transplantation
• Introduction of a new heart failure drug class within the last 4 weeks prior to randomization
• Cardiovascular hospitalization within the last 2 weeks immediately prior to randomization
• Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization
• Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to randomization
• Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD) within 90 days prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization
• Need for any cardiovascular surgery
• Mitral valve surgery is considered a therapeutic option for the subject
• Renal replacement therapy
• Uncontrolled hypertension (i.e., BP \>180 mmHg systolic and/or \>105 mmHg diastolic) or hypotension (i.e., BP \<90 mmHg systolic)
• Unstable angina pectoris as judged by the investigator, other clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias
• MWT distance \>450 meters
• Mitral Valve Area (MVA) by planimetry \<4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory
• Leaflet anatomy which may preclude MitraClip device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation that may include:

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (29)

Allgemein öffentliches Krankenhaus Elisabethinen Linz

Linz, Fadingerstraße 1, A-4020, Austria

Location

UZA

Edegem, Belgium

Location

Skejby Sykehus/Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense Universitetshospital

Odense, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Universitätsklinikum der RWTH - Aachen

Aachen, Germany

Location

Herz-Zentrum

Bad Krozingen, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Evangelish-Freikirchliches Krankenhaus, Bernau

Bernau, Germany

Location

Herzzentrum Göttingen Universitätsmedizin, Göttingen

Göttingen, Germany

Location

Asklepios Klinik St Georg, Hamburg

Hamburg, Germany

Location

Kardiologische Gemeinschaftspraxis Mathey-Schofer, Hamburg

Hamburg, Germany

Location

Universitäre Herzzentrum, Hamburg

Hamburg, Germany

Location

Uni-Klinikum Heidelberg

Heidelberg, Germany

Location

Johannes Gütenberg University, Mainz

Mainz, Germany

Location

Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale Ferrarotto Alessi, Catania

Catania, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale San Raffaele, Milano

Milan, Italy

Location

Azienda Ospedaliero Universitaria Pisana, Pisa

Pisa, Italy

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

St Antonius Ziekenhuis, Nieuwegein

Nieuwegein, Netherlands

Location

Hospital Sant Creu y Sant Pau,

Barcelona, Spain

Location

Karolinska University Hospital, Stockholm

Stockholm, Sweden

Location

Universitätsspital Basel

Basel, Switzerland

Location

Inselspital Bern

Bern, Switzerland

Location

Universitäts Spital Zürich

Zurich, Switzerland

Location

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MeSH Terms

Conditions

Cardiovascular Diseases; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Piotr Ponikowski, MD, PhD

  Military Hospital, Medical University, Wroclaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

AU (1); BE (1); DK (3); NL (3); DE (10); CH (3); SE (1); IT (5); FI (1); ES (1)