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Cardiovascular DiseasesRESHAPE-HFNCT01772108

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

A study testing MitraClip in people with Cardiovascular Diseases, run by Abbott Medical Devices at 29 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
MitraClip
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
29 sitesin 10 countries
Study dates
Apr 2013to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 39Show fewer
  • 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

Trial locations and contacts

29 sites in 10 countries.

29 sites in 10 countries

Germany10 sites

  • Universitätsklinikum der RWTH - Aachen

    Aachen

  • Herz-Zentrum

    Bad Krozingen

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Evangelish-Freikirchliches Krankenhaus, Bernau

    Bernau

  • Herzzentrum Göttingen Universitätsmedizin, Göttingen

    Göttingen

  • Asklepios Klinik St Georg, Hamburg

    Hamburg

  • Kardiologische Gemeinschaftspraxis Mathey-Schofer, Hamburg

    Hamburg

  • Universitäre Herzzentrum, Hamburg

    Hamburg

  • Uni-Klinikum Heidelberg

    Heidelberg

  • Johannes Gütenberg University, Mainz

    Mainz

Other trials in Germany

Italy5 sites

  • Spedali Civili di Brescia

    Brescia

  • Ospedale Ferrarotto Alessi, Catania

    Catania

  • Centro Cardiologico Monzino

    Milan

  • Ospedale San Raffaele, Milano

    Milan

  • Azienda Ospedaliero Universitaria Pisana, Pisa

    Pisa

Other trials in Italy

Denmark3 sites

  • Skejby Sykehus/Aarhus University Hospital

    Aarhus

  • Rigshospitalet

    Copenhagen

  • Odense Universitetshospital

    Odense

Other trials in Denmark

Netherlands3 sites

  • Academisch Medisch Centrum

    Amsterdam

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • St Antonius Ziekenhuis, Nieuwegein

    Nieuwegein

Other trials in Netherlands

Switzerland3 sites

  • Universitätsspital Basel

    Basel

  • Inselspital Bern

    Bern

  • Universitäts Spital Zürich

    Zurich

Other trials in Switzerland

Austria1 site

  • Allgemein öffentliches Krankenhaus Elisabethinen Linz

    Linz, Fadingerstraße 1, A-4020

Other trials in Austria

Belgium1 site

  • UZA

    Edegem

Other trials in Belgium

Finland1 site

  • Helsinki University Hospital

    Helsinki

Other trials in Finland

Spain1 site

  • Hospital Sant Creu y Sant Pau,

    Barcelona

Other trials in Spain

Sweden1 site

  • Karolinska University Hospital, Stockholm

    Stockholm

Other trials in Sweden

About this study

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.

Read the detailed 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.

Being tested
MitraClip
Keywords
Heart Valve Diseases
Medical subject headings
Cardiovascular Diseases, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MitraClipDevice

    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

Study groups in NCT01772108
Study groupRoleWhat they receive
MitraClip DeviceExperimentalSubjects randomized to the Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
Receives: Device: MitraClip
ControlNo interventionSubjects randomized to the Control group will receive optimal standard of care therapy alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: two years

Secondary outcomes (7)

  1. 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

    Measured: 30 days

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

  6. Change in Quality of Life (QoL) score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), at 12 months over baseline

    Measured: 12 months

  7. New York Heart Association (NYHA) Functional Class I/II at 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2014
  4. Study completionJan 2015

Why it stopped: As recruitment rate was lower than anticipated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01772108
Sponsor's protocol ID
12-513
Acronym
RESHAPE-HF
Status last verified
Nov 2018
First submitted
17 Jan 2013
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • McGee EC Jr. Should moderate or greater mitral regurgitation be repaired in all patients with LVEF <30%? Surgery, mitral regurgitation, and heart failure: the valves are all repairable but the patients are not. Circ Heart Fail. 2008 Nov;1(4):285-9. doi: 10.1161/CIRCHEARTFAILURE.108.800185. No abstract available.

    PubMed 19808304

  • Fruhwald F, Pieske B. Left ventricular remodelling in systolic heart failure using ivabradine. Slower is smaller is better? Eur Heart J. 2011 Oct;32(20):2481-2. doi: 10.1093/eurheartj/ehr317. Epub 2011 Aug 29. No abstract available.

    PubMed 21875857

  • Zannad F. Acute heart failure syndromes: the 'Cinderella' of heart failure research. European Journal Supplements. 2005 April 7;(suppl B):B8-B127.

  • Martinez-Selles M, Garcia Robles JA, Prieto L, Serrano JA, Munoz R, Frades E, Almendral J. Annual rates of admission and seasonal variations in hospitalizations for heart failure. Eur J Heart Fail. 2002 Dec;4(6):779-86. doi: 10.1016/s1388-9842(02)00116-2.

    PubMed 12453550

  • Reducing Heart Failure Hospitalization. Genesis Heart Institute. http://www.genesishealth.com/ghi/news/hf_hospitalization 2011 Oct 18.

  • Pino PG, Galati A, Terranova A. Functional mitral regurgitation in heart failure. J Cardiovasc Med (Hagerstown). 2006 Jul;7(7):514-23. doi: 10.2459/01.JCM.0000234770.88701.75.

    PubMed 16801813

  • American Heart Association/American College of Cardiology (AHA/ACC) 2009 update HF guidelines.

  • Linde C, Mealing S, Hawkins N, Eaton J, Brown B, Daubert JC; REVERSE study group. Cost-effectiveness of cardiac resynchronization therapy in patients with asymptomatic to mild heart failure: insights from the European cohort of the REVERSE (Resynchronization Reverses remodeling in Systolic Left Ventricular Dysfunction). Eur Heart J. 2011 Jul;32(13):1631-9. doi: 10.1093/eurheartj/ehq408. Epub 2010 Nov 25.

    PubMed 21112898

  • Lebrun F, Lancellotti P, Pierard LA. Quantitation of functional mitral regurgitation during bicycle exercise in patients with heart failure. J Am Coll Cardiol. 2001 Nov 15;38(6):1685-92. doi: 10.1016/s0735-1097(01)01605-9.

    PubMed 11704381

  • Schmitto JD, Lee LS, Mokashi SA, Bolman RM 3rd, Cohn LH, Chen FY. Functional mitral regurgitation. Cardiol Rev. 2010 Nov-Dec;18(6):285-91. doi: 10.1097/CRD.0b013e3181e8e648.

    PubMed 20926937

  • Michelena HI, Bichara VM, Margaryan E, Forde I, Topilsky Y, Suri R, Enriquez-Sarano M. Progress in the treatment of severe mitral regurgitation. Rev Esp Cardiol. 2010 Jul;63(7):820-31. doi: 10.1016/s1885-5857(10)70167-5. English, Spanish.

    PubMed 20609316

  • Southard J, and Rogers J. Current Catheter-Based Treatments of Functional Mitral Regurgitation. Cardiac Interventions. 2007 June.

  • Delling FN, Kang LL, Yeon SB, Kissinger KV, Goddu B, Manning WJ, Han Y. CMR predictors of mitral regurgitation in mitral valve prolapse. JACC Cardiovasc Imaging. 2010 Oct;3(10):1037-45. doi: 10.1016/j.jcmg.2010.06.016.

    PubMed 20947049

  • Otsuji Y, Handschumacher MD, Schwammenthal E, Jiang L, Song JK, Guerrero JL, Vlahakes GJ, Levine RA. Insights from three-dimensional echocardiography into the mechanism of functional mitral regurgitation: direct in vivo demonstration of altered leaflet tethering geometry. Circulation. 1997 Sep 16;96(6):1999-2008. doi: 10.1161/01.cir.96.6.1999.

    PubMed 9323092

  • Carabello BA, Nakano K, Corin W, Biederman R, Spann JF Jr. Left ventricular function in experimental volume overload hypertrophy. Am J Physiol. 1989 Apr;256(4 Pt 2):H974-81. doi: 10.1152/ajpheart.1989.256.4.H974.

    PubMed 2523200

Questions about this trial

What is this clinical trial studying?

A study testing MitraClip in people with Cardiovascular Diseases, run by Abbott Medical Devices at 29 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, Italy, Denmark, Netherlands, Switzerland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: As recruitment rate was lower than anticipated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01772108, which also lists 72 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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