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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01431222
First received: September 7, 2011
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Mitral Regurgitation
Device: percutaneous treatment by implanting a Mitra Clip device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Improvement of Dyspnoea of at least one class (NYHA-Classification) [ Time Frame: after 6 months ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Joerg Hausleiter, Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01431222     History of Changes
Other Study ID Numbers: IsarClip
Study First Received: September 7, 2011
Last Updated: September 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 16, 2014