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

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ClinicalTrials.gov Identifier: NCT00789139
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Ange FERRACCI, Hospital St. Joseph, Marseille, France

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).


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: ICM Implantation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
Study Start Date : October 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
AF monitoring by ICM
Only one arm
Device: ICM Implantation
Sub cutaneous implantation of the ICM




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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789139


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

Responsible Party: Dr Ange FERRACCI, CARDIOLOGIST, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT00789139     History of Changes
Other Study ID Numbers: RAPIDXT
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes