Radiofrequency Catheter Ablation for Chronic Atrial Fibri... | NCT00272636

Studies
Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

NCT00272636

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Jun 3, 2015Estimated

Enrollment

140

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Radiofrequency catheter ablation
Amiodarone and cardioversion

Countries

United States
Italy

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

Jan 2006

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

Nov 2002

Primary Completion Date

Not provided

Completion Date

Feb 2005

First Submitted Date

Jan 3, 2006

First Submission Date that Met QC Criteria

Jan 3, 2006

First Posted Date

Jan 6, 2006Estimated

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

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
San Raffaele University Hospital, Italy	OTHER

Description Module

Brief Summary

The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.

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

140

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.

Secondary Outcomes

Measure	Description	Time Frame
incidence of complications
changes in left atrial diameter
changes in left ventricular ejection fraction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic atrial fibrillation

Exclusion Criteria:

Left atrial diameter >55 mm
Left ventricular ejection fraction <0.30
Contraindication to amiodarone therapy or anticoagulation with warfarin
Presence of a mechanical prosthetic valve
History of a cerebrovascular accident
Presence of left atrial thrombus on TEE
Prior attempt at catheter or surgical ablation for atrial fibrillation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
Hakan Oral, MD	University of Michigan	Principal Investigator
Fred Morady, MD	University of Michigan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Health System		Ann Arbor	Michigan	48109	United States
San Raffaele Hospital

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

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation
D000638	Amiodarone
D004554	Electric Countershock

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency catheter ablation	Procedure
Amiodarone and cardioversion	Drug