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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2008 by Hospital St. Joseph, Marseille, France.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hospital St. Joseph, Marseille, France

ClinicalTrials.gov Identifier:

NCT00789139

First received: November 10, 2008

Last updated: NA

Last verified: November 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 10, 2008
Last Updated Date	November 10, 2008
Start Date ^ICMJE	October 2008
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2008)	Clinical exam and ECG record [ Time Frame: one month, 3 months, 6 months , 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
Official Title ^ICMJE	Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Cardiac Rhythm (AF)
Intervention ^ICMJE	Device: ICM Implantation Sub cutaneous implantation of the ICM
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	January 2011
Estimated Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00789139
Other Study ID Numbers ^ICMJE	RAPID XT
Has Data Monitoring Committee	Yes
Responsible Party	FERRACCI ANGE/ MD Principal investigator, SAINT JOSEPH hOSPITAL
Study Sponsor ^ICMJE	Hospital St. Joseph, Marseille, France
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital St. Joseph, Marseille, France
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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