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

Interventional Strategy to Abrogate Mitral Regurgitation Using the MitraClip System in High-Risk Patients Considered Unsuitable for Surgery (ISAR-CLIP)

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.

Study Overview

• Status: Unknown
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: percutaneous treatment by implanting a Mitra Clip device

Detailed Description

The presence of a significant mitral regurgitation (MR) seriously effects the patient's quality of life and is associated with an increased mortality rate. The operative treatment of MR - either mitral valve repair or replacement - is the current gold standard. However mere half of the patients with a severe and symptomatic MR actually undergo an operative treatment (EURO-HEART-SURVEY) due to restricted left ventricular ejection fraction, elderly patients with co-morbidities and high perioperative morbidity and mortality. In contrast, patients with severe and symptomatic MR not suitable for operation are treated with palliative medical therapy (heart insufficiency therapy). With the development of the MitraClip device - a minimal-invasive, percutaneous catheter-based technique - high-risk patients not suitable for surgery may receive a promising alternative treatment by approximating the mitral leaflets, thus creating a permanent leaflet coaptation and reducing or even abrogating the MR. The current data support the assumption of a safe and effective MR reduction with the MitraClip-System in inoperable high-risk patients with severe MR. But the feasibility still has to be proven in this special patient population.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joerg Hausleiter, MD; Phone Number: 4018 +49-89-1218-0; Email: hausleiter@dhm.mhn.de
• Study Contact Backup: Name: Hasema Lesevic, MD; Phone Number: +49-89-1218-0; Email: lesevic@dhm.mhn.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80636
      • Deutsches Herzzentrum Muenchen
      • Contact: Joerg Hausleiter, MD; Phone Number: 4018 +49-89-1218-0; Email: hausleiter@dhm.mhn.de
      • Contact: Hasema Lesevic, MD; Phone Number: +49-89-1218-0; Email: lesevic@dhm.mhn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: percutaneous treatment	Device: percutaneous treatment by implanting a Mitra Clip 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.; Other Names: Mitra Clip system
NO_INTERVENTION: optimal medical treatment	Device: percutaneous treatment by implanting a Mitra Clip 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.; Other Names: Mitra Clip system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of Dyspnoea of at least one class (NYHA-Classification)	after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite endpoint and clinical outcome measured by NYHA-classification	composite endpoint (death of any cause, myocardial infarction, stroke, sepsis, TIMI major bleeding, clip embolisation, partial clip detachement, acute renal failure); unscheduled hospitalization due to increased heart insuffiecency; changes in quality of life; echocardiographic parameters; loboratory parameters; resiliance measured by spiroergometry	1 year and 2 years after intervention

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Study Chair: Joerg Hausleiter, MD, Deutsches Herzzentrum Muenchen; Principal Investigator: Steffen Massberg, MD, Deutsches Herzzentrum Muenchen; Principal Investigator: Juergen Pache, MD, Deutsches Herzzentrum Muenchen; Principal Investigator: Hasema Lesevic, MD, Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (ESTIMATE): September 9, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2011
• Last Update Submitted That Met QC Criteria: September 8, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: echocardiography; inoperable; MitraClip; fluoroscopy; severe mitral regurgitation; interventional mitral valve reconstruction; EuroSCORE; STS Risk Score; percutaneous treatment of mitral regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: IsarClip