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

Mitral Valve Insufficiency Clinical Trial

— Reshape-HF2  

Official title:

A RandomizEd Study of tHe MitrACliP DEvice in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444338
• Other study ID #: Version No. 6.0
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: April 19, 2024

Study information

• Verified date: April 2024
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: April 19, 2024
• Est. primary completion date: April 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

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

Other:
• standard of care

Locations

Country	Name	City	State
Czechia	Klinika Kardiologie IKEM	Prague
Denmark	Rigshospitalet Copenhagen	Copenhagen
Denmark	OUH Odense	Odense
Germany	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
Greece	HYGEIA Hospital Athens	Athens
Greece	Interbalkan Medical Center	Thessaloníki
Greece	St. Luke's Hospital Thessaloniki	Thessaloníki
Italy	AOC Brescia	Brescia
Italy	Presidio Ospedaliero "G. Rodolico"	Catania
Poland	Cardiology Department at Samodzielny Publiczny Szpital Kliniczny nr 7	Katowice
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Krakow
Poland	Poznan Medical University	Poznan
Poland	Medical University Department of Heart Diseases	Wroclaw
Poland	Slaskie Centrum Chorób Serca	Zabrze
Portugal	Lisbon St. Maria Hospital	Lisbon
Portugal	Lisbon St. Marta Hospital	Lisbon
Portugal	Centro Hospitalar Vila Nova de Gaia / Espinho	Vila Nova de Gaia
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	HSCSP/Barcelona	Barcelona
Spain	HUL Leon	Leon
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Instituto de Ciencias del Corazón (ICICOR)	Valladolid
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Countries where clinical trial is conducted

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

References & Publications (1)

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 23. doi: 10.1002/ejhf.3247. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of total (first and recurrent) HF hospitalizations within 24 months	Rate of total (first and recurrent) HF hospitalizations within 24 months	24 months
Primary	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	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	at 12 months
Secondary	Change in 6 Minute Walking Test distance from baseline to 12 months	Change in 6 Minute Walking Test distance from baseline to 12 months	from baseline to 12 months
Secondary	All-cause mortality during all available follow-up	All-cause mortality during all available follow-up	during all available follow-up
Secondary	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	24 months
Secondary	Percentage of patients in NYHA function class I/II at 12 months	Percentage of patients in NYHA function class I/II at 12 months	12 months