Evaluation of the Cardioblate Closure Device in Facilitat... | NCT00841529

Studies
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

NCT00841529

Sponsor

Medtronic Cardiovascular

Status

Terminated

Last Update Posted

Oct 23, 2012Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Left Atrial Appendage Occlusion

Interventions

Medtronic LAA Occlusion Device

Countries

United States

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 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Medtronic Business Decision

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Feb 10, 2009

First Submission Date that Met QC Criteria

Feb 10, 2009

First Posted Date

Feb 11, 2009Estimated

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

Oct 1, 2012

Certification/Extension First Submitted that Passed QC Review

Oct 18, 2012

Certification/Extension First Posted Date

Oct 23, 2012Estimated

Last Update Submitted Date

Oct 18, 2012

Last Update Posted Date

Oct 23, 2012Estimated

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

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medtronic LAA Occlusion Device	Device	Placement of the occlusion band on the LAA		Medtronic Cardioblate Closure Left Atrial Appendage Occlusion Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete occlusion of the left atrial appendage		3 Months

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the composite incidence rate of device-related adverse events		Discharge/30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age
Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (>=60 years of age), CABG (< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
The subject is willing and able to provide written informed consent and comply with study requirements
The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)

Exclusion Criteria:

Thrombus in the LAA and/or left atrium
Prior LAA isolation attempts
Subject is unable to take an anticoagulant during the study follow-up period
Subject is undergoing an emergency cardiac procedure
Life expectancy of less than 12 months
Pregnancy or desire to be pregnant within the 12 months of the study procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick McCarthy, MD	Northwestern University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eisenhower Medical Center		Rancho Mirage	California	92270	United States
Yale University School of Medicine

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided