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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Ange FERRACCI, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier:
NCT00789139
First received: November 10, 2008
Last updated: June 18, 2015
Last verified: June 2015
  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: 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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Ange FERRACCI, CARDIOLOGIST, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT00789139     History of Changes
Other Study ID Numbers: RAPIDXT
Study First Received: November 10, 2008
Last Updated: June 18, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on June 29, 2015