A Multicenter Data Registry for Outcomes From Surgical Tr... | NCT00747838

Studies
A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias

NCT00747838

Sponsor

Virginia Commonwealth University

Status

Terminated

Last Update Posted

May 27, 2013Estimated

Enrollment

106Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Minimally Invasive Maze Procedure

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

May 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment.

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Sep 4, 2008

First Submission Date that Met QC Criteria

Sep 4, 2008

First Posted Date

Sep 5, 2008Estimated

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

May 24, 2013

Last Update Posted Date

May 27, 2013Estimated

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

Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.

Detailed Description

Not provided

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

106Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minimally Invasive Maze Procedure	Procedure	Minimally Invasive Surgical Correction of Atrial Fibrillation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation		One Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
> 18 years of age

Exclusion Criteria:

Patients unable to give adequate informed consent
Patients who are known to be pregnant, plan to become pregnant or are lactating
Inability to return for follow up
Patients who are prison inmates or institutionalized
Patients in an emergency state
Patients under the age of 18

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

Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation undergoing surgical correction.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28438723	Derived	Saini A, Hu YL, Kasirajan V, Han FT, Khan MZ, Wolfe L, Gunda S, Koneru JN, Ellenbogen KA. Long-term outcomes of minimally invasive surgical ablation for atrial fibrillation: A single-center experience. Heart Rhythm. 2017 Sep;14(9):1281-1288. doi: 10.1016/j.hrthm.2017.04.029. Epub 2017 Apr 22.
22541178	Derived

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