Af Ablation In Brady-Tachy Syndrome | NCT00740272

Studies
Af Ablation In Brady-Tachy Syndrome

NCT00740272

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Feb 4, 2019Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Brady-tachy Syndrome

Interventions

AF ablation + pacemaker implantation
Pacemaker implantation

Countries

France

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Aug 20, 2008

First Submission Date that Met QC Criteria

Aug 21, 2008

First Posted Date

Aug 22, 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

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

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 aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden.

The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.

Detailed Description

The study is a randomized study 1:1 AF ablation vs non AF ablation. Patients are followed for 1 year. 38 patients will be required to show a significant reduction in AF burden.

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	AF ablation + pacemaker	Procedure: AF ablation + pacemaker implantation
2	Active Comparator	Pacemaker	Procedure: Pacemaker implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AF ablation + pacemaker implantation	Procedure	regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)	1

Measure	Description	Time Frame
AF burden		1 year

Measure	Description	Time Frame
Quality of life		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

paroxystic AF
symptomatic pauses (>5s at night or 3s during daytime)

Exclusion Criteria:

permanent AF
age > 80 y
pregnant women
minors

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
Hôpital St joseph		Marseille			France
CHU