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Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

NCT04702451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2025-09-12

Study results available
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Summary

Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).

The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

Conditions

Interventions

PROCEDURE

Dispersion ablation + PVI

Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation

DEVICE

VX1

VX1-based dispersion mapping

PROCEDURE

PVI

Pulmonary vein antrum isolation

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • CardiaBase

    collaborator OTHER

  • Volta Medical

    lead INDUSTRY

Principal Investigators

  • Isabel Deisenhofer, MD · Deutsches Herzzentrum Muenchen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2023-12-27
Completion
2023-12-27
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

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 NCT04702451 on ClinicalTrials.gov