Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: ICM Implantation

• Registration Number: NCT00789139
• Lead Sponsor: Dr Ange FERRACCI

Brief Summary

Post Marketing study, Interventional, Prospective, non randomised

Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• AF thermoablation indication
• Informed Consent signed,
• Age between 18 & 75

Exclusion Criteria

• Participation to other clinical trial
• Non compliant patient
• Pregnant women
• Left Atrial thrombus
• Endocarditis, infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AF monitoring by ICM	ICM Implantation	Only one arm

Primary Outcome Measures

Name	Time	Method
Clinical exam and ECG record	one month, 3 months, 6 months , 12 months

Trial Locations

Locations (1)

Saint Joseph Hospital; 🇫🇷 Marseille, France