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CompletedNCT02444338Reshape-HF2Updated Sep 19, 2024

A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation

An interventional study of MitraClip and standard of care in Mitral Valve Insufficiency, sponsored by University Medical Center Goettingen. Completed at 35 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University Medical Center Goettingen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
505
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.

Read the detailed description

The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.

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Conditions studied

  • Mitral Valve Insufficiency
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In context

Mitral Valve Insufficiency

459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.

This study's enrollment of 505 is above the median of 61 across 274 interventional studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

University Medical Center Goettingen is the lead sponsor of 61 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
  • Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.
  • Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 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 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
  • Ambulatory patient with symptomatic congestive heart failure (CHF) in NYHA functional class II to IV (despite optimal standard of care therapy as assessed within 30 days preceding randomization) and with LVEF 20% to 50%. Note: LVEF needs to be determined by one of the following methods: transthoracic echocardiography (TTE), contrast ventriculography, gated blood pool scan, cardiac magnetic resonance) within 90 days prior to randomization
  • Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness

Key Exclusion Criteria:

  • Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).
  • Status 1 heart transplant or prior orthotropic heart transplantation.
  • Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.
  • Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization. Note:Acute coronary syndrome (ACS) is defined as an ACS that requires an intervention. Increased troponin without acute symptoms and chest pain is not defined as ACS.
  • Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.
  • Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within 90 day 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 the preferred therapeutic option for the subject
  • Renal replacement therapy
  • 6-Minute Walk Test (6MWT) distance > 475 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
505 participants (actual)

Study arms

  • Active comparator
    Control Group

    optimal standard of care therapy

    Other: standard of care

  • Experimental
    Device Group

    MitraClip device plus optimal standard of care therapy

    Device: MitraClip · Other: standard of care

Interventions

  • DeviceMitraClip

    Implantation of the MitraClip System for patients with chronic heart failure.

  • Otherstandard of care
06

What researchers measure

Primary outcomes

  1. Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months

    Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months

    Time frame: 24 months

  2. Rate of total (first and recurrent) HF hospitalizations within 24 months

    Rate of total (first and recurrent) HF hospitalizations within 24 months

    Time frame: 24 months

  3. Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months

    Change in quality of life (i.e. overall KCCQ score) from baseline to 12 months

    Time frame: 12 months

Secondary outcomes

  1. Percentage of patients with mitral regurgitation grade of 2+ or lower at 12 months as assessed by the Echocardiography Core Laboratory

    Percentage of patients with mitral regurgitation grade of 2+ or lower at 12 months as assessed by the Echocardiography Core Laboratory

    Time frame: at 12 months

  2. Change in 6 Minute Walking Test distance from baseline to 12 months

    Change in 6 Minute Walking Test distance from baseline to 12 months

    Time frame: from baseline to 12 months

  3. All-cause mortality during all available follow-up

    All-cause mortality during all available follow-up

    Time frame: during all available follow-up

  4. Rate of total (first and recurrent) hospitalizations for any cause within 24 months

    Rate of total (first and recurrent) hospitalizations for any cause within 24 months

    Time frame: 24 months

  5. Percentage of patients in NYHA function class I/II at 12 months

    Percentage of patients in NYHA function class I/II at 12 months

    Time frame: 12 months

07

Study locations

35 sites
  • Klinika Kardiologie IKEM
    Prague, 14021, Czechia
  • Rigshospitalet Copenhagen
    Copenhagen, Denmark
  • OUH Odense
    Odense, Denmark
  • Charité
    Berlin, 12200, Germany
  • Universitätsklinikum Düsseldorf
    Düsseldorf, 40225, Germany
  • Universitätsklinikum Essen
    Essen, 45122, Germany
  • Johanniter Krankenhaus
    Genthin, 39576, Germany
  • University Medical Center Goettingen
    Göttingen, 37075, Germany
  • Universitätsklinikum Halle
    Halle, 06097, Germany
  • University Hospital Heidelberg
    Heidelberg, 69120, Germany
  • Universitätsklinikum Jena
    Jena, 07747, Germany
  • University Hospital Mainz
    Mainz, 55131, Germany
  • Universitätsklinik Würzburg
    Würzburg, 97080, Germany
  • HYGEIA Hospital Athens
    Athens, Greece
  • Interbalkan Medical Center
    Thessaloníki, 57001, Greece
  • St. Luke's Hospital Thessaloniki
    Thessaloníki, Greece
  • AOC Brescia
    Brescia, Italy
  • Cardiology Department at Samodzielny Publiczny Szpital Kliniczny nr 7
    Katowice, 40-635, Poland
  • Krakowski Szpital Specjalistyczny im. Jana Pawła II
    Krakow, 31-202, Poland
  • Poznan Medical University
    Poznań, 61-848, Poland
  • Medical University Department of Heart Diseases
    Wrocław, 50981, Poland
  • Śląskie Centrum Chorób Serca
    Zabrze, 41-800, Poland
  • Lisbon St. Marta Hospital
    Lisbon, 1169-1024, Portugal
  • Lisbon St. Maria Hospital
    Lisbon, Portugal
  • Centro Hospitalar Vila Nova de Gaia / Espinho
    Vila Nova de Gaia, Portugal
  • Hospital Germans Trias i Pujol
    Badalona, Spain
  • HUL Leon
    Leon, Spain
  • Hospital Universitario Central de Asturias
    Oviedo, Spain
  • Instituto de Ciencias del Corazón (ICICOR)
    Valladolid, Spain
  • Royal Infirmary of Edinburgh
    Edinburgh, United Kingdom
  • Golden Jubilee National Hospital
    Glasgow, United Kingdom
  • Castle Hill Hospital
    Hull, United Kingdom
  • The Royal Brompton and Harefield Hospitals
    London, United Kingdom
  • Wythenshawe Hospital of South Manchester - Manchester University NHS Foundation Trust (MFT)
    Manchester, United Kingdom
  • Royal Stoke Hospital - University Hospital of North Midlands
    Stoke-on-Trent, United Kingdom
08

References and documents

Publications

  • Anker SD, Friede T, von Bardeleben RS, Butler J, Khan MS, Diek M, Heinrich J, Geyer M, Placzek M, Ferrari R, Abraham WT, Alfieri O, Auricchio A, Bayes-Genis A, Cleland JGF, Filippatos G, Gustafsson F, Haverkamp W, Kelm M, Kuck KH, Landmesser U, Maggioni AP, Metra M, Ninios V, Petrie MC, Rassaf T, Ruschitzka F, Schafer U, Schulze PC, Spargias K, Vahanian A, Zamorano JL, Zeiher A, Karakas M, Koehler F, Lainscak M, Oner A, Mezilis N, Theofilogiannakos EK, Ninios I, Chrissoheris M, Kourkoveli P, Papadopoulos K, Smolka G, Wojakowski W, Reczuch K, Pinto FJ, Wiewiorka L, Kalarus Z, Adamo M, Santiago-Vacas E, Ruf TF, Gross M, Tongers J, Hasenfuss G, Schillinger W, Ponikowski P; RESHAPE-HF2 Investigators. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1799-1809. doi: 10.1056/NEJMoa2314328. Epub 2024 Aug 31. PubMed 39216092 ↗
  • Anker SD, Friede T, von Bardeleben RS, Butler J, Fatima K, Diek M, Heinrich J, Hasenfuss G, Schillinger W, Ponikowski P. Randomized investigation of the MitraClip device in heart failure: Design and rationale of the RESHAPE-HF2 trial design. Eur J Heart Fail. 2024 Apr;26(4):984-993. doi: 10.1002/ejhf.3247. Epub 2024 Apr 23. PubMed 38654139 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02444338
Lead sponsor
University Medical Center Goettingen
Responsible party
Karsten Gavenis (on behalf of Principle Investigator Prof. Wolfgang Schillinger and Prof. Stefan D. Anker, University Medical Center Goettingen) — Principal investigator
First posted
May 14, 2015
Start date
Mar 2015
Primary completion
Apr 19, 2024
Completion
Apr 19, 2024
Last update
Sep 19, 2024

Study contacts

Wolfgang Schillinger, Prof.
principal investigator · University Medical Center Göttingen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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