Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2025-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Substrate Modification

After obtaining a voltage map of the LA, substrate modification by catheter ablation using an irrigated radio frequency current ablation catheter will be performed aiming at low-voltage areas (LVA) \< 0.5mV.

Group Type ACTIVE_COMPARATOR

Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

Intervention Type PROCEDURE

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

LAA Isolation

Patients will undergo LAA-isolation using the cryoballoon (CB). Six weeks later patients will undergo re-mapping. In case of residual conduction LAA-reisolation will be performed. In case of durable LAA isolation, interventional LAA occlusion is recommended.

Group Type ACTIVE_COMPARATOR

Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

Intervention Type PROCEDURE

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

Interventions

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Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.

* Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter
* Age 18-85 years.
* Left atrial size \< 55mm.
* Left ventricular ejection fraction ≥ 45%.
* Patient is able to provide informed consent and is willing to comply with the study protocol.

Exclusion Criteria

* Contraindications for repeat ablation
* Reconnected pulmonary veins according to mapping results with a spiral mapping catheter
* Minimal diameter of LAA neck ≥25mm
* History of mitral valve surgery
* Severe mitral valve regurgitation
* Inability to be treated with oral anticoagulation
* Presence of intracardiac thrombi
* Chronic obstructive pulmonary disease treated with long acting bronchodilatators
* Asthma
* Obstructive sleep apnea syndrome
* Pregnancy
* Participation in other clinical studies
* Unwilling to follow the study protocol and to attend follow-up visits

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No