A Clinical Study of the CardiAQ™ TMVI System (Transapical... | NCT02478008

Studies
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

NCT02478008

Sponsor

Edwards Lifesciences

Status

Terminated

Last Update Posted

Mar 31, 2016Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Mitral Insufficiency
Heart Valve Disease
Cardiovascular Disease
Heart Disease

Interventions

CardiAQ TMVI System (Transapical DS)

Countries

Denmark
France
Netherlands
United Kingdom

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Edwards acquired CardiAQ and opted to terminate this study. 2 patients were enrolled and follow-up is complete. No further enrollment or follow-up will occur.

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jun 17, 2015

First Submission Date that Met QC Criteria

Jun 18, 2015

First Posted Date

Jun 23, 2015Estimated

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

Mar 29, 2016

Last Update Posted Date

Mar 31, 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 the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

Detailed Description

Not provided

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

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CardiAQ TMVI System (Transapical DS)	Experimental		Device: CardiAQ TMVI System (Transapical DS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CardiAQ TMVI System (Transapical DS)	Device		CardiAQ TMVI System (Transapical DS)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite Major Adverse Event Rate		30-Day
Composite Major Adverse Event Rate		12-Month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

NYHA Classification ≥ III
Left Ventricular Ejection Fraction ≥ 30%
Mitral regurgitation ≥ Grade 3+
Subject meets anatomical eligibility criteria for the investigational device

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Søndergaard, MD, DMSc	Rigshospitalet University Hospital (Copenhagen, Denmark)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet University Hospital		Copenhagen			Denmark
Centre hospitalier régional universitaire de Lille

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency
D006349	Heart Valve Diseases
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided