Recurrence of Arrhythmias After Pulmonary Veins Isolation... | NCT00789139

Studies
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

NCT00789139

Sponsor

Dr Ange FERRACCI

Status

Completed

Last Update Posted

Jun 19, 2015Estimated

Enrollment

47Actual

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

ICM Implantation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Nov 10, 2008

First Submission Date that Met QC Criteria

Nov 10, 2008

First Posted Date

Nov 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2015

Last Update Posted Date

Jun 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AF monitoring by ICM	Other	Only one arm	Device: ICM Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICM Implantation	Device	Sub cutaneous implantation of the ICM	AF monitoring by ICM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical exam and ECG record		one month, 3 months, 6 months , 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ANGE FERRACCI, md	Unity Health Toronto	Principal Investigator
ANDRE PISAPIA, MD	Unity Health Toronto	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Joseph Hospital		Marseille		13008	France

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided