ASTRO AF: Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Sponsor

Cardioangiologisches Centrum Bethanien (Other)

Overall Status

Recruiting

CT.gov ID

NCT04056390

Collaborator

Medtronic (Industry), CRO Kottmann (Other)

256

Enrollment

Locations

Arms

Anticipated Duration (Months)

36.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.
Active Comparator: 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.	Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

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

Active Comparator: 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.

Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy

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

Outcome Measures

Primary Outcome Measures

Arrhythmia Recurrence [Day 91-365 after index ablation]
Freedom from AF/AT

Secondary Outcome Measures

Incidence of periprocedural complications [day 0 - day 365]
Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding
Number of electrical cardioversions and hospitalizations [day0 - day 365]
Number of electrical cardioversions and hospitalizations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum	Bad Oeynhausen	Germany	32545
2	Cardioangiologisches Centrum Bethanien	Frankfurt/Main	Germany	60431
3	Universitätsmedizin Greifswald	Greifswald	Germany	17475
4	Universitäres Herz- und Gefäßzentrum UKE Hamburg	Hamburg	Germany	20246
5	Universitätsklinikum Köln	Köln	Germany	50937
6	Universitätsklinikum Schleswig Holstein	Lübeck	Germany	23538
7	Universitäts Klinikum Ulm	Ulm	Germany	89081

Sponsors and Collaborators

Cardioangiologisches Centrum Bethanien
Medtronic
CRO Kottmann

Investigators

Principal Investigator: Boris Schmidt, MD, Cardioangiologisches Centrum Bethanien

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cardioangiologisches Centrum Bethanien

ClinicalTrials.gov Identifier:

NCT04056390

Other Study ID Numbers:

SF124/2017

First Posted:

Aug 14, 2019

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Cardioangiologisches Centrum Bethanien

catheter ablation

Additional relevant MeSH terms:

Atrial Fibrillation

Recurrence

Study Results

No Results Posted as of Apr 11, 2022