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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01431222
Other study ID # IsarClip
Secondary ID
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


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
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