Af Ablation In Brady-Tachy Syndrome

Brady-tachy Syndrome Clinical Trial

— Alternative  

Official title:

Af Ablation In Brady-Tachy Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00740272
• Other study ID #: SJM-FR01
• Status: Terminated
• Phase: N/A
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• paroxystic AF

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

Exclusion Criteria:

• permanent AF

• age > 80 y

• pregnant women

• minors

Related Conditions & MeSH terms

• Brady-tachy Syndrome
• Sick Sinus Syndrome
• Syndrome

Intervention

Procedure:
• AF ablation + pacemaker implantation
regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)
• Pacemaker implantation
regular pacemaker implantation

Locations

Country	Name	City	State
France	Hôpital St joseph	Marseille
France	CHU	Rouen
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF burden		1 year
Secondary	Quality of life		1 year