(MitraClip in Non-Responders to Cardiac Resynchronization Therapy)

NCT02592889 | Unknown Phase 4

• 1 other identifier: MITRA-CRT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Functional mitral regurgitation (FMR) is a common finding in patients with dilated cardiomyopathy and reduced left ventricular ejection fraction (LVEF). The presence of a relevant FMR (grade ≥2) is associated with a higher morbidity and mortality. Cardiac resynchronization therapy (CRT) has been shown to be effective in patients with dilated cardiomyopathy and reduced LVEF. In selected patients, CRT has been linked to clinical improvement and reduced mortality. Importantly, 38% of patients with clinical indication for CRT present moderate or severe (FMR). Although FMR might be reduced after CRT, the persistence of a relevant FMR (≥2) after CRT ranges between 40% and 50% and is an independent predictor of no clinical response. In these patients, surgical FMR correction is frequently turned down as a result of a high surgical risk. Percutaneous repair of the mitral valve with the MitraClip system has demonstrated promising results in patients with dilated cardiomyopathy and reduced LVEF5. In a cohort of patients with no response to CRT and FMR ≥2, Auricchio et al showed significant clinical improvement with LVEF recovery and reduction in left ventricle (LV) volumes after MitraClip. The absence of randomization, the retrospective nature of the study and the subsequent selection biases were however major limitations that impeded solid conclusions. The objective of the present study is to assess the efficacy and safety of the MitraClip system in non-responders to CRT and FMR ≥2.

Conditions

MITRAL REGURGITATION

Keywords

MITRAL REGURGITATION

Outcome Measures

Primary Outcomes (1)

• Number of participants without adverse events related with the therapy and clinical improvement

  Number of participants without adverse events related with the therapy (stroke, device embolization, emergent surgery/pericardiocentesis or procedural related mortality) and clinical improvement defined by improvement \>10% in 6 min-walking test compared to the baseline situation and no readmissions for heart failure, heart transplantation or mortality. SAFETY Definition: Stroke, device embolization, emergent surgery/pericardiocentesis and procedural related mortality.

  1 YEAR CLINICAL

Study Arms (2)

CONTROL

NO INTERVENTION

OPTIMIZED MEDICAL TREATMENT

DEVICE

ACTIVE COMPARATOR

MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM + OPTIMIZED MEDICAL TREATMENT

Device: MITRACLIP

Interventions

MITRACLIP DEVICE

MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM

DEVICE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Absence of clinical response to CRT defined by baseline NYHA 3 or NYHA 2 with a hospital admission for HF within the last 12 months.
• Adequate CRT therapy (correct stimulation in \>98% heart beats).
• Correct position of the cardiac leads.
• Patients with atrial fibrillation will be included but balanced in both groups (the presence of AF is and independent factor of clinical response).
• Wide QRS (\>0.12) and LBBB pre-CRT.
• LVEF 15-40% (as a surgical risk criteria).
• Left ventricle end-diastolic diameters \<75 mm (as anatomical criteria for MitraClip feasibility).

You may not qualify if:

• Severe Renal Insufficiency (DFGe \<30).
• Life expectancy \< 1 year.
• Anatomical contraindication for MitraClip (in order to avoid selection biases, all patients must be Mitraclip candidates).
• Inadequate treatment compliance or difficult follow-up.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Abbott: collaborator

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Related Publications (1)

• Freixa X, Tolosana JM, Cepas-Guillen PL, Hernandez-Enriquez M, Sanchis L, Flores-Umanzor E, Farrero M, Andrea R, Roque M, Carretero MJ, Regueiro A, Brugaletta S, Rodes-Cabau J, Mont L, Sitges M, Sabate M, Castel MA. Edge-to-Edge Transcatheter Mitral Valve Repair Versus Optimal Medical Treatment in Nonresponders to Cardiac Resynchronization Therapy: The MITRA-CRT Trial. Circ Heart Fail. 2022 Dec;15(12):e009501. doi: 10.1161/CIRCHEARTFAILURE.121.009501. Epub 2022 Sep 20. No abstract available.

  PMID: 36124767 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• XAVIER FREIXA, MD

  Hospital Clinic of Barcelona

  STUDY CHAIR

Central Study Contacts

XAVIER FREIXA, MD

CONTACT

34932275519; FREIXA@CLINIC.UB.ES

MARCO HERNANDEZ, MD

CONTACT

34932275519; MHERNANE@CLINIC.UB.ES

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: mitraclip versus control

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 30, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

ES (1)