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Characterization and Elimination of Mother Rotors

NCT01924377 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-07-27

No results posted yet for this study

Summary

Recent clinical studies have shown that atrial fibrillation (AF) in humans might be sustained by localized sources called "mother rotors" which exhibit persistent, fast, and well organized activity during AF and play an important role in the generation and maintenance of the fibrillatory activity. In this study, investigators aim to identify the electrophysiological characteristics of mother rotors during atrial fibrillation in patients with paroxysmal and persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.

Conditions

Interventions

PROCEDURE

standard circumferential pulmonary vein isolation by radiofrequency ablation catheter

To perform circumferential pulmonary vein isolation left and right circumferential lines will be created with contiguous focal radiofrequency lesions at a distance \>5 mm from the pulmonary vein ostia. Two additional ablation lines will be performed in the posterior left atrium (LA), and an ablation line will be placed in the mitral isthmus to prevent postablation LA flutter. Patients with a history of typical atrial flutter will also undergo cavotricuspid isthmus ablation.

PROCEDURE

CPVI + rotors' identification and ablation

In CPVI + Rotor arm, two LA sequential maps will be collected before and after CPVI, respectively. During each map creation, rotor electrograms will be identified by the physician. Rotors will be ablated after collecting the second LA sequential map.

Sponsors & Collaborators

  • Ettore Sansavini Health Science Foundation

    collaborator OTHER

  • Mediolanum Cardio Research

    collaborator OTHER

  • Maria Cecilia Hospital

    lead OTHER

Principal Investigators

  • Carlo Pappone, MD · Maria Cecilia Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-05-28
Primary Completion
2018-07-25
Completion
2018-07-25

Countries

  • Italy

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 NCT01924377 on ClinicalTrials.gov