Mitralign Percutaneous Annuloplasty First in Man Study
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|ClinicalTrials.gov Identifier: NCT01852149|
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : March 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Functional Mitral Regurgitation||Device: MPAS Implant||Not Applicable|
The primary objective of this study is to test the ability to safely perform mitral posterior annulus plication with the Mitralign System in eligible patients with chronic functional MR using an endovascular approach. Data obtained from this study, combined with extensive pre-clinical data, will provide important technical and early clinical outcome information that will drive the next phase of clinical investigation and potentially enhance the future design of the Mitralign Percutaneous Annuloplasty System. It is anticipated that the Mitralign System will one day provide physicians with a safe and effective alternative therapy for treating patients who are candidates for mitral valve repair and offer a primary therapy option for patients superior to current treatment modalities.
This is a single-arm, multi-center, prospective study designed to test the safety and feasibility of the MPAS to treat patients with chronic, functional MR by performing plication of the posterior mitral annulus.
Up to a total of 36 patients with chronic functional mitral regurgitation will be enrolled: 1.) Up to 16 patients (12 patients + 1 roll-in patient per site) will be enrolled in Phase I. Up to thirty-four (34) patients will be enrolled in Phase II (MITRALIGN ADVANTAGE). All patients will be followed for 24 months. Up to 5 sites in Europe and South America will participate.
Study procedures include implantation of the MPAS, Trans-Esophogeal Echo, Trans-Thoracic Echo, Blood test, 6-min walk, Quality of Life, Chest X-ray and ECG.
Descriptive Statistics will be conducted for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mitralign Percutaneous Annuloplasty First in Man (FIM) Study|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||September 2015|
Experimental: MPAS Implant
Device: MPAS Implant
The Mitralign System consists of a set of catheters that enable the physician to position and place sutures and anchors through the posterior (back) annulus of the mitral valve under the guidance of echocardiography and fluoroscopy. Once the anchored sutures are in place, the sutures are pulled together. When the valve leaflets are close together, the sutures are locked with at least one stainless steel lock. The Bident Translation Catheter allows implantation of two pairs of pledgets. Each pair of pledgets plicates the annulus and then the pledgets are locked together from the ventricular side with a lock.
- The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days [ Time Frame: 30 Days post implant ]The primary study endpoint will assess acute safety using a composite clinical endpoint of device-related net adverse cardiac events (NACE) at 30 days. The components of NACE are defined as the occurrence of device related mortality, myocardial infarction, cardiac tamponade, cardiac surgery or stroke in per protocol population
- Echocardiographic measures [ Time Frame: 6 Months ]Measurement of Ventricular diameter and Mitral Regurgitant Grade
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852149
|Instituto Dante Passanese de Cardiologia|
|Sao Paulo, Brazil, 04012-909|
|Universitats Klinikum Bonn|
|Bonn, Germany, D-53127|
|Essen, Germany, D-45138|
|Asklepios Klinik St Georg|
|Hamburg, Germany, D-2009|
|Bern University Hospital|
|Bern, Switzerland, CH-3010|
|Principal Investigator:||Eberhard Grube, MD||Universitats Klinikum Bonn|
|Study Director:||Kimberlie O'Connell, MBA||Mitralign, Inc.|