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

NCT02444338 | Completed DMC

• 1 other identifier: Version No. 6.0
• Study Type: interventional
• Target: 505
• Locations: 9 countries
• Sites: 35

Brief 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.

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (3)

• 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

  24 months

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

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

  24 months

• 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

  12 months

Secondary Outcomes (5)

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

  at 12 months

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

  from baseline to 12 months

• All-cause mortality during all available follow-up

  during all available follow-up

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

  24 months

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

  12 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

optimal standard of care therapy

Other: standard of care

Device Group

EXPERIMENTAL

MitraClip device plus optimal standard of care therapy

Device: MitraClip; Other: standard of care

Interventions

MitraClip DEVICE

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

Device Group

standard of care OTHER

Control Group; Device Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (35)

Klinika Kardiologie IKEM

Prague, 14021, Czechia

Location

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

OUH Odense

Odense, Denmark

Location

Charité

Berlin, 12200, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Johanniter Krankenhaus

Genthin, 39576, Germany

Location

University Medical Center Goettingen

Göttingen, 37075, Germany

Location

Universitätsklinikum Halle

Halle, 06097, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

University Hospital Mainz

Mainz, 55131, Germany

Location

Universitätsklinik Würzburg

Würzburg, 97080, Germany

Location

HYGEIA Hospital Athens

Athens, Greece

Location

Interbalkan Medical Center

Thessaloniki, 57001, Greece

Location

St. Luke's Hospital Thessaloniki

Thessaloniki, Greece

Location

AOC Brescia

Brescia, Italy

Location

Cardiology Department at Samodzielny Publiczny Szpital Kliniczny nr 7

Katowice, 40-635, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, 31-202, Poland

Location

Poznan Medical University

Poznan, 61-848, Poland

Location

Medical University Department of Heart Diseases

Wroclaw, 50981, Poland

Location

Śląskie Centrum Chorób Serca

Zabrze, 41-800, Poland

Location

Lisbon St. Marta Hospital

Lisbon, 1169-1024, Portugal

Location

Lisbon St. Maria Hospital

Lisbon, Portugal

Location

Centro Hospitalar Vila Nova de Gaia / Espinho

Vila Nova de Gaia, Portugal

Location

Hospital Germans Trias i Pujol

Badalona, Spain

Location

HUL Leon

León, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Instituto de Ciencias del Corazón (ICICOR)

Valladolid, Spain

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

Castle Hill Hospital

Hull, United Kingdom

Location

The Royal Brompton and Harefield Hospitals

London, United Kingdom

Location

Wythenshawe Hospital of South Manchester - Manchester University NHS Foundation Trust (MFT)

Manchester, United Kingdom

Location

Royal Stoke Hospital - University Hospital of North Midlands

Stoke-on-Trent, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39216092 RESULT

• 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.

  PMID: 38654139 RESULT

• McMurray JJV, Metra M. Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2097-2098. doi: 10.1056/NEJMe2302924. No abstract available.

  PMID: 37256981 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Wolfgang Schillinger, Prof.

  University Medical Center Göttingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: PROBE * outcome assessment: blinded * patient \& investigator: open
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: on behalf of Principle Investigator Prof. Wolfgang Schillinger and Prof. Stefan D. Anker

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: March 1, 2015
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CZ (1); ES (4); GB (6); DE (10); PL (5); DK (2); GR (3); IT (1); PT (3)