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

This study has been completed.
Information provided by (Responsible Party):
Dr Ange FERRACCI, Hospital St. Joseph, Marseille, France Identifier:
First received: November 10, 2008
Last updated: June 18, 2015
Last verified: June 2015

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).

Condition Intervention Phase
Atrial Fibrillation
Device: ICM Implantation
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

Resource links provided by NLM:

Further study details as provided by Hospital St. Joseph, Marseille, France:

Primary Outcome Measures:
  • Clinical exam and ECG record [ Time Frame: one month, 3 months, 6 months , 12 months ]

Enrollment: 47
Study Start Date: October 2008
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AF monitoring by ICM
Only one arm
Device: ICM Implantation
Sub cutaneous implantation of the ICM


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00789139

Saint Joseph Hospital
Marseille, France, 13008
Sponsors and Collaborators
Principal Investigator: ANGE FERRACCI, md St. Joseph Hospital Health Center
Study Director: ANDRE PISAPIA, MD St. Joseph Hospital Health Center
  More Information

Responsible Party: Dr Ange FERRACCI, CARDIOLOGIST, Hospital St. Joseph, Marseille, France Identifier: NCT00789139     History of Changes
Other Study ID Numbers: RAPIDXT
Study First Received: November 10, 2008
Last Updated: June 18, 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes processed this record on April 28, 2017