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

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ClinicalTrials.gov Identifier: NCT01431222
Recruitment Status : Unknown
Verified September 2011 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen

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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: percutaneous treatment by implanting a Mitra Clip device Phase 4

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional Strategy to Abrogate Mitral Regurgitation Using the MitraClip System in High-Risk Patients Considered Unsuitable for Surgery (ISAR-CLIP)
Study Start Date : September 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Mitra Clip system




Primary Outcome Measures :
  1. Improvement of Dyspnoea of at least one class (NYHA-Classification) [ Time Frame: after 6 months ]

Secondary Outcome Measures :
  1. composite endpoint and clinical outcome measured by NYHA-classification [ Time Frame: 1 year and 2 years after intervention ]
    • 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431222


Contacts
Contact: Joerg Hausleiter, MD +49-89-1218-0 ext 4018 hausleiter@dhm.mhn.de
Contact: Hasema Lesevic, MD +49-89-1218-0 lesevic@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum Muenchen Not yet recruiting
Munich, Bavaria, Germany, 80636
Contact: Joerg Hausleiter, MD    +49-89-1218-0 ext 4018    hausleiter@dhm.mhn.de   
Contact: Hasema Lesevic, MD    +49-89-1218-0    lesevic@dhm.mhn.de   
Sponsors and Collaborators
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

Responsible Party: Joerg Hausleiter, Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01431222     History of Changes
Other Study ID Numbers: IsarClip
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011

Keywords provided by Deutsches Herzzentrum Muenchen:
severe mitral regurgitation
interventional mitral valve reconstruction
inoperable
EuroSCORE
STS Risk Score
MitraClip
fluoroscopy
echocardiography
percutaneous treatment of mitral regurgitation

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases