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AF Substrate Mapping and Guided Ablation

NCT02571218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-07-05

Study results available
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Summary

In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with 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

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Substrate+mCPVA

The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.

DEVICE

mCPVA

The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Carlo Pappone, MD, PhD · I.R.C.C.S. Policlinico San Donato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Italy

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 NCT02571218 on ClinicalTrials.gov