NCT02520960

Brief Summary

Prospective observational multicentric study evaluating the efficacy of considering unipolar signal modification during radio frequency catheter ablation of patients with symptomatic paroxysmal atrial fibrillation in France between November 2013 and January 2015. All procedures were conducted according to the standard clinical care and current guidelines. Pulmonary vein isolation was guided according to force (at least 10 grams) and application vector (perpendicular to the wall) developed until the atrial unipolar electrogram recording became a complete positive signal. Patients were discharged from hospital free of any anti-arrhythmic drugs. Recurrence of arrhythmias at 12 months (primary outcome) was assessed by continuous 48-hour Holter at 1, 3, 6, 9 and 12 months post-catheter ablation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

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

November 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

August 4, 2015

Last Update Submit

August 18, 2016

Conditions

Atrial FibrillationArrhythmia

Keywords

Catheter AblationPulmonary Vein IsolationRadiofrequency

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Atrial Arrhythmias

    12 months

Secondary Outcomes (1)

  • Frequency of Pulmonary Vein Reconnection

    30 mins

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients referred to the participating institutions, from November 2013 to January 2015, for catheter ablation of symptomatic and drug resistant PAF. Paroxysmal AF was considered any episode of AF that terminates spontaneously in less than seven days.

You may qualify if:

  • Paroxysmal symptomatic and drug resistant atrial fibrillation (AF). Paroxysmal AF was considered any episode of AF that terminates spontaneously in less than seven days.

You may not qualify if:

  • age \<18 or \>80 year-old
  • left atrial volume \>200 ml
  • presence of a mechanical mitral valve prosthesis
  • impaired thyroid function
  • left ventricular ejection fraction \<40%
  • patient under guardianship
  • contraindication to anticoagulant therapy
  • current malignancy
  • prior catheter or surgical AF ablation
  • persistent or long-standing persistent AF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Les Franciscaines

Nîmes, 30000, France

Location

Related Publications (3)

  • Bortone A, Brault-Noble G, Appetiti A, Marijon E. Elimination of the negative component of the unipolar atrial electrogram as an in vivo marker of transmural lesion creation: acute study in canines. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):905-11. doi: 10.1161/CIRCEP.115.002894. Epub 2015 Jun 19.

    PMID: 26092576RESULT

  • Bortone A, Appetiti A, Bouzeman A, Maupas E, Ciobotaru V, Boulenc JM, Pujadas-Berthault P, Rioux P. Unipolar signal modification as a guide for lesion creation during radiofrequency application in the left atrium: prospective study in humans in the setting of paroxysmal atrial fibrillation catheter ablation. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1095-102. doi: 10.1161/CIRCEP.113.000749. Epub 2013 Oct 4.

    PMID: 24097371RESULT

  • Bortone A, Lagrange P, Cauchemez B, Durand C, Dieuzaide P, Prevot S, Mechulan A, Pambrun T, Martin R, Parlier P, Masse A, Marijon E, Albenque JP. Elimination of the negative component of the unipolar electrogram as a local procedural endpoint during paroxysmal atrial fibrillation catheter ablation using contact-force sensing: the UNIFORCE study. J Interv Card Electrophysiol. 2017 Sep;49(3):299-306. doi: 10.1007/s10840-017-0264-4. Epub 2017 Jun 22.

    PMID: 28643171DERIVED

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Agustin Bortone, MD

    Service de Cardiologie, Hôpital Privé Les Franciscaines, Nîmes, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Head of the Clinical Electrophysiology Unit

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 13, 2015

Study Start

November 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

FR(1)