NCT00789139

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

4.2 years

First QC Date

November 10, 2008

Last Update Submit

June 18, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Clinical exam and ECG record

    one month, 3 months, 6 months , 12 months

Study Arms (1)

AF monitoring by ICM

OTHER

Only one arm

Device: ICM Implantation

Interventions

ICM ImplantationDEVICE

Sub cutaneous implantation of the ICM

AF monitoring by ICM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AF thermoablation indication
  • Informed Consent signed,
  • Age between 18 \& 75

You may not qualify if:

  • Participation to other clinical trial
  • Non compliant patient
  • Pregnant women
  • Left Atrial thrombus
  • Endocarditis, infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph Hospital

Marseille, 13008, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ANGE FERRACCI, md

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • ANDRE PISAPIA, MD

    Unity Health Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CARDIOLOGIST

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations

FR(1)