Mitral Regurgitation
Conditions
Keywords
severe mitral regurgitation, interventional mitral valve reconstruction, inoperable, EuroSCORE, STS Risk Score, MitraClip, fluoroscopy, echocardiography, percutaneous treatment of mitral regurgitation
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.
Interventions
DEVICEpercutaneous 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.
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of Dyspnoea of at least one class (NYHA-Classification) | after 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| composite endpoint and clinical outcome measured by NYHA-classification | 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 |
Countries
Germany
Contacts
Primary ContactJoerg Hausleiter, MD
Backup ContactHasema Lesevic, MD
Outcome results
None listed