Mitralign Percutaneous Annuloplasty First in Man Study

NCT01852149 | Completed

• 1 other identifier: CLPR-005
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Functional Mitral Regurgitation

Keywords

Mitral Valve Regurgitation; Coaptation; Mitral Valve Repair; Plication; Leaflet; Annulus; Mitral Annuloplasty

Outcome Measures

Primary Outcomes (1)

• 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

  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

  30 Days post implant

Secondary Outcomes (1)

• Echocardiographic measures

  6 Months

Study Arms (1)

MPAS Implant

EXPERIMENTAL

MPAS Implant

Device: MPAS Implant

Interventions

MPAS Implant DEVICE

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.

Also known as: Bident, Plication, Mitral annuloplasty, annulus, Mitral Regurgitation

MPAS Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with chronic functional mitral regurgitation.
• Patient is greater than 18 years old.
• Documented symptoms of CHF - NYHA II-IV.
• Left ventricular ejection fraction between 30 and 60 percent.
• Acceptable candidate for cardiac surgery and/or blood transfusion.
• Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study- specific tests or procedures are performed.
• Willing to comply with all specified follow-up evaluations.
• Mitral regurgitation grade 2.
• Patient has a mitral plane to apex dimension 5 cm.
• Structurally normal mitral valve.

You may not qualify if:

• Patient with significant organic mitral valve pathology such as myxomatous degeneration, mitral valve prolapse or flail leaflets moderate or severe valve calcifications, ruptured papillary muscles or ruptured chordae tendinae.
• Previous mitral valve repair or mitral valve replacement.
• Patient with mitral stenosis.
• Patient with moderate or severe aortic stenosis and or moderate or severe aortic regurgitation.
• Patient with endocarditis.
• MI within 30 days prior to the index procedure.
• Unstable angina.
• Percutaneous Coronary Intervention within 30 days prior to the index procedure.
• CABG within 3 months prior to the index procedure.
• Planned PCI less than 30 days post index procedure.
• Planned CABG within 6 months post index procedure.
• Patient with severe, multivessel coronary artery disease and who cannot tolerate sudden hemodynamic changes or acute hemoglobin drop.
• Cardiogenic Shock characterized by systolic pressure less than 80 mm Hg and or central filling pressure greater than 20 mm Hg, or cardiac index less than 1.8 liters per minute per m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure greater than 80 mm Hg and a cardiac index greater than 1.8 liters per minute per m2.
• Patient with peripheral vascular disease or tortuousity that would prevent percutaneous access with a 14 Fr introducer sheath or intervention with the Mitralign system.
• Cerebrovascular Accident within the past 6 months.

Sponsors & Collaborators

• Mitralign, Inc.: lead
• Medstar Health Research Institute: collaborator
• The Cooper Health System: collaborator
• Cardiovascular Research Center, Brazil: collaborator

Study Sites (5)

Instituto Dante Passanese de Cardiologia

São Paulo, 04012-909, Brazil

Location

Universitats Klinikum Bonn

Bonn, D-53127, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, D-45138, Germany

Location

Asklepios Klinik St Georg

Hamburg, D-2009, Germany

Location

Bern University Hospital

Bern, CH-3010, Switzerland

Location

Related Publications (1)

• Nickenig G, Schueler R, Dager A, Martinez Clark P, Abizaid A, Siminiak T, Buszman P, Demkow M, Ebner A, Asch FM, Hammerstingl C. Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System. J Am Coll Cardiol. 2016 Jun 28;67(25):2927-36. doi: 10.1016/j.jacc.2016.03.591.

  PMID: 27339489 DERIVED

Related Links

• Sponsor website

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Eberhard Grube, MD

  Universitats Klinikum Bonn

  PRINCIPAL INVESTIGATOR

• Kimberlie O'Connell, MBA

  Mitralign, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 13, 2013
• Study Start: August 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

CH (1); BR (1); DE (3)