Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery

NCT01431222 | Unknown Phase 4 DMC

• 1 other identifier: IsarClip
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.

Conditions

Mitral Regurgitation

Keywords

severe mitral regurgitation; interventional mitral valve reconstruction; inoperable; EuroSCORE; STS Risk Score; MitraClip; fluoroscopy; echocardiography; percutaneous treatment of mitral regurgitation

Outcome Measures

Primary Outcomes (1)

• Improvement of Dyspnoea of at least one class (NYHA-Classification)

  after 6 months

Secondary Outcomes (1)

• composite endpoint and clinical outcome measured by NYHA-classification

  1 year and 2 years after intervention

Study Arms (2)

percutaneous treatment

ACTIVE COMPARATOR

Device: percutaneous treatment by implanting a Mitra Clip device

optimal medical treatment

NO INTERVENTION

Device: percutaneous treatment by implanting a Mitra Clip device

Interventions

percutaneous treatment by implanting a Mitra Clip device DEVICE

With a minimal-invasive, percutaneous catheter-based technique and trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance, the MitraClip device grasps and approximates the mitral leaflets thus creating a double-orifice mitral valve with a permanent leaflet coaptation and a reduction or even abrogation of mitral regurgitation.

Also known as: Mitra Clip system

optimal medical treatment; percutaneous treatment

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years
• signed written consent
• symptomatic patients (NYHA-stadium ≥ III) for at least 3 months with an exploited medical heart insufficiency therapy
• increased perioperative risk with a logistic EuroScore ≥ 15 or STS-Score ≥ 15
• MR grade ≥ 2, amenable for MitraClip intervention assessed by an experienced interventional cardiologist
• Affirmation of in-operability by a "Heart-Team" consisting of either 1 cardiac surgeon and 1 cardiologist or 3 cardiologists

You may not qualify if:

• one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation
• implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months
• solid tumor with a live expectancy \< 1 year

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, Bavaria, 80636, Germany

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Joerg Hausleiter, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Steffen Massberg, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

• Juergen Pache, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

• Hasema Lesevic, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joerg Hausleiter, MD

CONTACT

+49-89-1218-0; hausleiter@dhm.mhn.de

Hasema Lesevic, MD

CONTACT

+49-89-1218-0; lesevic@dhm.mhn.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: September 9, 2011

Record last verified: 2011-09

Locations

DE (1)