NCT00740272

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

August 20, 2008

Last Update Submit

February 1, 2019

Conditions

Brady-tachy Syndrome

Keywords

brady-tachy syndromeAF ablation

Outcome Measures

Primary Outcomes (1)

  • AF burden

    1 year

Secondary Outcomes (1)

  • Quality of life

    1 year

Study Arms (2)

1

EXPERIMENTAL

AF ablation + pacemaker

Procedure: AF ablation + pacemaker implantation

2

ACTIVE COMPARATOR

Pacemaker

Procedure: Pacemaker implantation

Interventions

AF ablation + pacemaker implantationPROCEDURE

regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)

1
Pacemaker implantationPROCEDURE

regular pacemaker implantation

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • permanent AF
  • age \> 80 y
  • pregnant women
  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital St joseph

Marseille, France

Location

CHU

Rouen, France

Location

Clinique Pasteur

Toulouse, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(3)