Clinical trial NCT01431222: Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
Official title: Interventional Strategy to Abrogate Mitral Regurgitation Using the MitraClip System in High-Risk Patients Considered Unsuitable for Surgery (ISAR-CLIP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mitral Regurgitation
Keywords: severe mitral regurgitation
interventional mitral valve reconstruction
inoperable
EuroSCORE
STS Risk Score
MitraClip
fluoroscopy
echocardiography
percutaneous treatment of mitral regurgitation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Improvement of Dyspnoea of at least one class (NYHA-Classification)
timeFrame: after 6 months
Secondary outcomes:
measure: composite endpoint and clinical outcome measured by NYHA-classification
timeFrame: 1 year and 2 years after intervention
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Joerg Hausleiter, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Steffen Massberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum Muenchen
name: Juergen Pache, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum Muenchen
name: Hasema Lesevic, MD
role: PRINCIPAL_INVESTIGATOR
References: