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RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.

NCT04442113 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-14

No results posted yet for this study

Summary

Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity. Catheter ablation is a safe treatment which is effective for paroxysmal AF but the success rate for persistent AF remains approximately 50% at 1 year. A new mapping technique, called Stochastic Trajectory Analysis of Ranked signals (STAR Mapping™) Method, has recently been developed. In a pilot study, localised sources driving AF were consistently mapped and ablated with excellent acute and long term outcomes. This trial will test the clinical effectiveness of this approach by comparing conventional ablation with pulmonary vein isolation (PVI) to PVI plus STAR mapping™ guided ablation. We plan to test this through a prospective multicenter randomized controlled trial including 177 patients.

Conditions

Interventions

PROCEDURE

Pulmonary vein isolation plus ablation guided by novel STAR mapping™

Catheter ablation for persistent AF consisting of pulmonary vein isolation plus additional ablation guided by the novel STAR mapping™ software on a computer device.

PROCEDURE

Pulmonary vein isolation

Catheter ablation for persistent AF consisting of pulmonary vein isolation (the standard treatment for AF)

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Rhythm AI Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-09-01
Completion
2022-09-01

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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 NCT04442113 on ClinicalTrials.gov