NCT01852149

Mitralign Percutaneous Annuloplasty First in Man Study

Mitralign Percutaneous Annuloplasty First in Man (FIM) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mitralign, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation. No formal test of hypothesis is proposed for this trial.

Detailed description

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.

Conditions

• Functional Mitral Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2014-03-01
• Completion: 2015-09-01
• First posted: 2013-05-13
• Last updated: 2016-03-18

Locations

5 sites across 3 countries: Brazil, Germany, Switzerland