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

Mitral Regurgitation Clinical Trial

— ISAR-CLIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01431222
• Other study ID #: IsarClip
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 7, 2011
• Last updated: September 8, 2011
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: September 2011
• Source: Deutsches Herzzentrum Muenchen
• Contact: Joerg Hausleiter, MD
• Phone: +49-89-1218-0
• Email: hausleiter[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Dyspnoea of at least one class (NYHA-Classification)		after 6 months	No
Secondary	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	Yes