Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Atrial Fibrillation Clinical Trial

— ASTRO AF  

Official title:

Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04056390
• Other study ID #: SF124/2017
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: February 15, 2025

Study information

• Verified date: November 2023
• Source: Cardioangiologisches Centrum Bethanien
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy
Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.

Locations

Country	Name	City	State
Germany	Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum	Bad Oeynhausen
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt/Main
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Universitäres Herz- und Gefäßzentrum UKE Hamburg	Hamburg
Germany	Universitätsklinikum Köln	Köln
Germany	Universitätsklinikum Schleswig Holstein	Lübeck
Germany	Universitäts Klinikum Ulm	Ulm

Sponsors (3)

Lead Sponsor	Collaborator
Cardioangiologisches Centrum Bethanien	CRO Kottmann, Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia Recurrence	Freedom from AF/AT	Day 91-365 after index ablation
Secondary	Incidence of periprocedural complications	Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding	day 0 - day 365
Secondary	Number of electrical cardioversions and hospitalizations	Number of electrical cardioversions and hospitalizations	day0 - day 365