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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
  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
Cardiac Rhythm (AF)
 Device: ICM Implantation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ICM Implantation
    Sub cutaneous implantation of the ICM
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789139

Locations
France
Saint Joseph Hospital Recruiting
Marseille, France, 13008
Contact: FERRACCI, MD         lcurel@hopital-saint-joseph.fr    
Principal Investigator: ANGE FERRACCI, MD            
Sub-Investigator: ANDRE PISAPIA, MD            
Sub-Investigator: MICHEL BREMONDY, MD            
Sub-Investigator: JACQUES FAURE, MD            
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
  More Information

No publications provided

Responsible Party: FERRACCI ANGE/ MD Principal investigator, SAINT JOSEPH hOSPITAL
ClinicalTrials.gov Identifier: NCT00789139     History of Changes
Other Study ID Numbers: RAPID XT
Study First Received: November 10, 2008
Last Updated: November 10, 2008
Health Authority: France:Agence francaise de Sécurité sanitaire des Produits de Santé

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

ClinicalTrials.gov processed this record on May 19, 2013