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

Cardiovascular Diseases Clinical Trial

— RESHAPE-HF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01772108
• Other study ID #: 12-513
• Status: Terminated
• Phase: N/A
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2018
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a clinical evaluation of the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with chronic heart failure. The objective was to further study the safety and effectiveness of the MitraClip System for the treatment of clinically significant functional mitral regurgitation in New York Heart Association Functional Class III or IV chronic heart failure patients.

Due to lower than expected recruitment rate, Abbott Vascular sponsorship of the trial was terminated early.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 6MWT 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:

• Evidence of calcification in the grasping area

• Presence of significant cleft in the grasping area

• Lack of both primary and secondary chordal support in the grasping area

• Prior mitral valve surgery

• Coaptation length =2 mm

• Leaflet mobility length <1 cm

• Presence of an IVC filter in the femoral vein that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis (DVT) is present

• Contraindication to transseptal catheterization

• Subjects in whom transesophageal echocardiography is contraindicated

• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)

• Presence of any of the following:

• Severe aortic stenosis (aortic valve area <1.0 cm2) or severe aortic regurgitation

• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)

• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology

• Hemodynamic instability requiring inotropic support or mechanical heart circulatory support

• Active infections requiring current antibiotic therapy

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

• Severe right ventricular failure or severe tricuspid regurgitation

• History of bleeding diathesis or coagulopathy or subject who refuses blood transfusions

• Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to randomization and be adherent to an accepted method of contraception

• Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator

• Currently participating in another therapeutic or interventional heart failure trial, or in any trial of an unapproved drug or device (Subjects participating in observational studies or registries may be considered as eligible)

• Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure
• Mitral Valve Insufficiency

Intervention

Device:
• MitraClip
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

Locations

Country	Name	City	State
Austria	Allgemein öffentliches Krankenhaus Elisabethinen Linz	Linz	Fadingerstraße 1
Belgium	UZA	Edegem
Denmark	Skejby Sykehus/Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense Universitetshospital	Odense
Finland	Helsinki University Hospital	Helsinki
Germany	Universitätsklinikum der RWTH - Aachen	Aachen
Germany	Herz-Zentrum	Bad Krozingen
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Evangelish-Freikirchliches Krankenhaus, Bernau	Bernau
Germany	Herzzentrum Göttingen Universitätsmedizin, Göttingen	Göttingen
Germany	Asklepios Klinik St Georg, Hamburg	Hamburg
Germany	Kardiologische Gemeinschaftspraxis Mathey-Schofer, Hamburg	Hamburg
Germany	Universitäre Herzzentrum, Hamburg	Hamburg
Germany	Uni-Klinikum Heidelberg	Heidelberg
Germany	Johannes Gütenberg University, Mainz	Mainz
Italy	Spedali Civili di Brescia	Brescia
Italy	Ospedale Ferrarotto Alessi, Catania	Catania
Italy	Centro Cardiologico Monzino	Milano
Italy	Ospedale San Raffaele, Milano	Milano
Italy	Azienda Ospedaliero Universitaria Pisana, Pisa	Pisa
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	St Antonius Ziekenhuis, Nieuwegein	Nieuwegein
Spain	Hospital Sant Creu y Sant Pau,	Barcelona
Sweden	Karolinska University Hospital, Stockholm	Stockholm
Switzerland	Universitätsspital Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Universitäts Spital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland, 

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* Note: There are 72 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mitral regurgitation severity reduction to mild or mild-to-moderate at 12 months		12 months
Secondary	Change in Left Ventricular End Diastolic Volume (LVEDV) at 12 months over baseline		12 months
Secondary	Change in Left Ventricular End Systolic Volume (LVESV) at 12 months over baseline		12 months
Secondary	Change in 6 Minute Walk Test (6MWT) distance at 12 months over baseline		12 months
Secondary	Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), at 12 months over baseline		12 months
Secondary	New York Heart Association (NYHA) Functional Class I/II at 12 months		12 months