Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Atrial Fibrillation Clinical Trial

— RAPID XT  

Official title:

Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789139
• Other study ID #: RAPIDXT
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2008
• Last updated: June 18, 2015
• Start date: October 2008
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: Hospital St. Joseph, Marseille, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• ICM Implantation
Sub cutaneous implantation of the ICM

Locations

Country	Name	City	State
France	Saint Joseph Hospital	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Dr Ange FERRACCI

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical exam and ECG record		one month, 3 months, 6 months , 12 months	No