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Unipolar Atrial Electrogram Modification Combined to the Contact Force Sensing Technology for Pulmonary Vein Isolation

NCT02520960 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 215

Last updated 2016-08-19

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Clinique St Pierre, Perpignan, France

    collaborator UNKNOWN

  • Clinique Ambroise Paré, Neuilly sur Seine, France

    collaborator UNKNOWN

  • Hôpital Privé Clairval, Marseille, France

    collaborator UNKNOWN

  • Infirmerie Protestante de Lyon, Lyon, France

    collaborator AMBIG

  • Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France

    collaborator UNKNOWN

  • Centre Hospitalier Régional Universitaire Montpellier

    collaborator OTHER

  • Paris Cardiovascular Research Center (Inserm U970)

    collaborator OTHER_GOV

  • Clinique Pasteur

    collaborator OTHER

  • Hôpital Privé Les Franciscaines

    lead OTHER

Principal Investigators

  • Agustin Bortone, MD · Service de Cardiologie, Hôpital Privé Les Franciscaines, Nîmes, France

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520960 on ClinicalTrials.gov