Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM (RAPID XT)

Dr Ange FERRACCI

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: ICM Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00789139

RAPIDXT

Details and patient eligibility

About

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).

Enrollment: 47 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

AF monitoring by ICM

Other group

Description:

Only one arm

Treatment:

Device: ICM Implantation