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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789139
First Posted: November 11, 2008
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Ange FERRACCI, Hospital St. Joseph, Marseille, France
  Purpose

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: None (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 Dr Ange FERRACCI, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Dr Ange FERRACCI, CARDIOLOGIST, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT00789139     History of Changes
Other Study ID Numbers: RAPIDXT
First Submitted: November 10, 2008
First Posted: November 11, 2008
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