Mitralign Percutaneous Annuloplasty System for Chronic Fu... | NCT01740583

Studies
Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

NCT01740583

Sponsor

Mitralign, Inc.

Status

Unknown status

Last Update Posted

Oct 17, 2016Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Mitral Valve Regurgitation

Interventions

percutaneous annuloplasty

Countries

Colombia
France
Paraguay
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jan 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Nov 30, 2012

First Submission Date that Met QC Criteria

Nov 30, 2012

First Posted Date

Dec 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

Detailed Description

The ALIGN study is a single arm, prospective study. The objective of the study is to investigate the safety and performance of a catheter-based plication device intended to reduce the circumference of the dilated mitral valve. The study will enroll up to 50 subjects from up to 5 sites (Paraguay, Columbia, Dominican Republic, Brazil, and India) who will be followed for 36 months post index procedure. Enrollment is defined at the time the study device is inserted into the body and patients will be followed at 30 days, and Months 6, 12, 24 and 36 post index procedure.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
annuloplasty	Experimental	All patients will receive treatment with the Mitralign Percutaneous Annuloplasty System (MPAS).	Device: percutaneous annuloplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
percutaneous annuloplasty	Device	plication of the mitral valve annulus	annuloplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Events (MAE)	MAE defined as occurrence of any of the following: Mitral valve-related surgery/intervention, myocardial infarction, cardiac tamponade, stroke, device and/or procedure-related death	within 30 days post procedure

Secondary Outcomes

Measure	Description	Time Frame
Echocardiographic Outcomes	Freedom from an increase in ventricular diameter	at 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NYHA II-IV
Structurally normal mitral valve
At least Grade 2 mitral regurgitation
Left ventricular ejection fraction not less than 20% and not greater than 45%
Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm

Exclusion Criteria:

Pregnant or lactating female
Mitral stenosis
Mod/severe aortic stenosis or regurgitation
Mod/severe tricuspid stenosis or regurgitation
Endocarditis
Previous mitral valve repair or MV replacement
Bioprosthetic or mechanical aortic valve
Known unstable angina or MI within 30 days prior to procedure
CVA within past 6 months
Known contraindications to blood transfusion, contrast dye, DAPT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrian Ebner, M.D.	Sanatorio Italiano (The Italian Hospital)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica CardioVID		Medellín	Antioquia		Colombia
Antonio Dager, MD

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D015154	Esophageal Motility Disorders

Browse Leaves

Not provided

Browse Branches

Not provided