Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

NCT ID: NCT00789139

Last Updated: 2015-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AF monitoring by ICM

Only one arm

Group Type OTHER

ICM Implantation

Intervention Type DEVICE

Sub cutaneous implantation of the ICM

Interventions

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ICM Implantation

Sub cutaneous implantation of the ICM

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Ange FERRACCI

OTHER

Sponsor Role lead

Responsible Party

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Dr Ange FERRACCI

CARDIOLOGIST

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ANGE FERRACCI, md

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

ANDRE PISAPIA, MD

Role: STUDY_DIRECTOR

Unity Health Toronto

Locations

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Saint Joseph Hospital

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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RAPIDXT

Identifier Type: -

Identifier Source: org_study_id

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