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

NCT ID: NCT02444338

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 505 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2024-04-19

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.

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.

Conditions

Mitral Valve Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

optimal standard of care therapy

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: OTHER

Device Group

MitraClip device plus optimal standard of care therapy

Group Type: EXPERIMENTAL

MitraClip

Intervention Type: DEVICE

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

standard of care

Intervention Type: OTHER

Interventions

MitraClip

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

Intervention Type: DEVICE

standard of care

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Goettingen

OTHER

Sponsor Role: lead

Responsible Party

Karsten Gavenis

on behalf of Principle Investigator Prof. Wolfgang Schillinger and Prof. Stefan D. Anker

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Schillinger, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Göttingen

Locations

Klinika Kardiologie IKEM

Prague, , Czechia

Rigshospitalet Copenhagen

Copenhagen, , Denmark

OUH Odense

Odense, , Denmark

Charité

Berlin, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Universitätsklinikum Essen

Essen, , Germany

Johanniter Krankenhaus

Genthin, , Germany

University Medical Center Goettingen

Göttingen, , Germany

Universitätsklinikum Halle

Halle, , Germany

University Hospital Heidelberg

Heidelberg, , Germany

Universitätsklinikum Jena

Jena, , Germany

University Hospital Mainz

Mainz, , Germany

Universitätsklinik Würzburg

Würzburg, , Germany

HYGEIA Hospital Athens

Athens, , Greece

Interbalkan Medical Center

Thessaloniki, , Greece

St. Luke's Hospital Thessaloniki

Thessaloniki, , Greece

AOC Brescia

Brescia, , Italy

Cardiology Department at Samodzielny Publiczny Szpital Kliniczny nr 7

Katowice, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, , Poland

Poznan Medical University

Poznan, , Poland

Medical University Department of Heart Diseases

Wroclaw, , Poland

Śląskie Centrum Chorób Serca

Zabrze, , Poland

Lisbon St. Marta Hospital

Lisbon, , 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

León, , 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

Countries

Czechia; Denmark; Germany; Greece; Italy; Poland; Portugal; Spain; United Kingdom

References

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.

Reference Type: RESULT

PMID: 39216092 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38654139 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37256981 (View on PubMed)

Other Identifiers

Version No. 6.0

Identifier Type: -

Identifier Source: org_study_id