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Impact Of Different Ablation Approaches on Outcome In Coexistent Atrial Fibrillation and Flutter

NCT01439386 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2017-10-19

No results posted yet for this study

Summary

This prospective, multi-center, single blinded study aims to compare the influence of two different catheter ablation strategies, on long-term ablation outcome in terms of AF recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF) with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.

Conditions

  • Atrial Arrhythmia
  • Quality of Life

Interventions

PROCEDURE

Catheter ablation

PVAI with or without CTI ablation

PROCEDURE

Catheter ablation

CTI ablation only

Sponsors & Collaborators

  • Monzino Hospital, Milan, Italy

    collaborator UNKNOWN

  • Ospedale dell'Angelo, Venezia-Mestre

    collaborator OTHER

  • Catholic University, Italy

    collaborator OTHER

  • University of Rome Tor Vergata

    collaborator OTHER

  • Texas Cardiac Arrhythmia Research Foundation

    lead OTHER

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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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 NCT01439386 on ClinicalTrials.gov