NCT02093949

Brief Summary

To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 3, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

March 14, 2014

Results QC Date

October 18, 2016

Last Update Submit

October 3, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure

    percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure

    up to 240 min

Secondary Outcomes (7)

  • % of Patients With Sinus Rhythm Conversion During the Procedure

    180 min

  • Radiofrequency Time (Min)

    up to 300 min

  • Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation

    18 Months post ablation

  • Number of Patients With Major Adverse Events During and up to 18 Months After Procedure

    18 months post ablation

  • Maximum Sustained AF Duration

    from first AF episode to baseline

  • +2 more secondary outcomes

Study Arms (2)

Studied

Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation

Procedure: Routine substrate ablation without pulmonary vein Isolation

Control

The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.

Procedure: Routine conventional ablation with pulmonary vein Isolation

Interventions

Routine substrate ablation without pulmonary vein IsolationPROCEDURE
Studied
Routine conventional ablation with pulmonary vein IsolationPROCEDURE
Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient from 18 to 85, with AF\* (paroxysmal, and persistent AF) and indication of AF ablation (including redos)\* \*In accordance with the recommendation of European Society of Cardiology (2010).

You may qualify if:

  • Patient from 18 to 85, with AF\* (paroxysmal, and persistent AF) and indication of AF ablation (including redos)\* \*In accordance with the recommendation of European Society of Cardiology (2010).

You may not qualify if:

  • organized atrial activity (Atrial tachycardia or Flutter)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Saint Joseph

Marseille, 13008, France

Location

CHU

Nice, France

Location

Institut Mutualiste de Montsouris

Paris, France

Location

Related Publications (1)

  • Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

    PMID: 28104073DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Julien Seitz
Organization
Saint joseph hospital
jseitz@hopital-saint-joseph.fr
+330491807044

Study Officials

  • Julien Seitz, MD

    St Joseph hospital Marseille

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD , Cardiologist Rythmologist

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 21, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

August 1, 2016

Last Updated

November 6, 2017

Results First Posted

May 3, 2017

Record last verified: 2017-10

Locations

FR(3)