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Substrate Versus Trigger Ablation for Paroxysmal Atrial Fibrillation

NCT02169037 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-06-04

No results posted yet for this study

Summary

This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV isolation).

Conditions

Interventions

PROCEDURE

FIRM Ablation

Substrate ablation for AF, via ablation of rotors and focal sources alone.

PROCEDURE

Conventional AF ablation with PVI

Trigger Based Ablation for AF, using Pulmonary Vein Isolation alone.

Sponsors & Collaborators

Principal Investigators

  • Sanjiv M Narayan, MD, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02169037 on ClinicalTrials.gov