MedTrace Logo

Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

NCT04056390 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-11-14

No results posted yet for this study

Summary

The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation.

The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation.

After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification.

After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) \< 0.5mV.

Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance).

The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting \> 30 seconds between day 91 and 365 after the index procedure.

Conditions

Interventions

PROCEDURE

Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • CRO Kottmann

    collaborator UNKNOWN

  • Cardioangiologisches Centrum Bethanien

    lead OTHER

Principal Investigators

  • Boris Schmidt, MD · Cardioangiologisches Centrum Bethanien

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
2019-08-01
Primary Completion
2024-02-15
Completion
2025-02-15

Countries

  • Germany

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 NCT04056390 on ClinicalTrials.gov