Short Term Outcomes From Minimally Invasive Surgery for t... | NCT00571597

Studies
Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation

NCT00571597

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Apr 14, 2014Estimated

Enrollment

118Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Dec 10, 2007

First Submission Date that Met QC Criteria

Dec 10, 2007

First Posted Date

Dec 12, 2007Estimated

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

Apr 10, 2014

Last Update Posted Date

Apr 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 assess the efficacy of minimally invasive surgery for atrial fibrillation.

Detailed Description

Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transtelephonic monitoring for the identification of post surgical Atrial Fibrillation		six months and 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 or older
paroxysmal, persistent, or permanent atrial fibrillation

Exclusion Criteria:

concomitant heart surgery requiring open thoracotomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Eligible subjects will be male or females age 18-85 that have elected to undergo or have undergone a minimally invasive "minimaze" surgery for the treatment of atrial firillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth A Ellenbogen, MD	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology Virginia Commonwealth University		Richmond	Virginia	23298	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19808492	Background	Han FT, Kasirajan V, Kowalski M, Kiser R, Wolfe L, Kalahasty G, Shepard RK, Wood MA, Ellenbogen KA. Results of a minimally invasive surgical pulmonary vein isolation and ganglionic plexi ablation for atrial fibrillation: single-center experience with 12-month follow-up. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):370-7. doi: 10.1161/CIRCEP.109.854828. Epub 2009 Jun 2.
19864190

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