Back to resultsRecurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM (RAPID XT)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ICM Implantation
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- Saint Joseph Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
AF monitoring by ICM
Arm Description
Only one arm
Outcomes
Primary Outcome Measures
Clinical exam and ECG record
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00789139
Brief Title
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
Acronym
RAPID XT
Official Title
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Ange FERRACCI
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AF monitoring by ICM
Arm Type
Other
Arm Description
Only one arm
Intervention Type
Device
Intervention Name(s)
ICM Implantation
Intervention Description
Sub cutaneous implantation of the ICM
Primary Outcome Measure Information:
Title
Clinical exam and ECG record
Time Frame
one month, 3 months, 6 months , 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANGE FERRACCI, md
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ANDRE PISAPIA, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Study Director
Facility Information:
Facility Name
Saint Joseph Hospital
City
Marseille
ZIP/Postal Code
13008
Country
France
12. IPD Sharing Statement
Learn more about this trial
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
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