Repeat Ablation Procedure in Patients With Relapse of Atr... | NCT01229306

Studies
Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

NCT01229306

Sponsor

Deutsches Herzzentrum Muenchen

Status

Unknown status

Last Update Posted

May 3, 2013Estimated

Enrollment

108Estimated

Phase

Not Applicable

Conditions

Ablation
Paroxysmal Atrial Fibrillation

Interventions

Ablation

Countries

Germany

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2013Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Oct 26, 2010

First Submission Date that Met QC Criteria

Oct 26, 2010

First Posted Date

Oct 27, 2010Estimated

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 2, 2013

Last Update Posted Date

May 3, 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

Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Detailed Description

Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure we compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

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

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
reisolation of all PV and additional anterior line	Experimental		Procedure: Ablation
reisolation of all pulmonary veins	Placebo Comparator		Procedure: Ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ablation	Procedure	Ablation of atrial fibrillation	reisolation of all PV and additional anterior line reisolation of all pulmonary veins

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom of atrial arrhythmias

Secondary Outcomes

Measure	Description	Time Frame
Quality of life, number of reconnected pulmonary veins, safety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

relapse of atrial fibrillation

Exclusion Criteria:

contraindication for ablation

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum	Recruiting	München	Bayer	80636	Germany

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