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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| CRO Kottmann | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substrate Modification | Active Comparator | 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. |
|
| LAA Isolation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy | Procedure | Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation. |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia Recurrence | Freedom from AF/AT | Day 91-365 after index ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of periprocedural complications | Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding | day 0 - day 365 |
| Number of electrical cardioversions and hospitalizations |
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Inclusion Criteria:
• Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Schmidt, MD | Cardioangiologisches Centrum Bethanien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum | Bad Oeynhausen | 32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39371020 | Derived | Schmidt B, Bordignon S, Metzner A, Sommer P, Steven D, Dahme T, Busch M, Tilz RR, Schaack D, Rillig A, Sohns C, Sultan A, Weinmann-Emhardt K, Hummel A, Vogler J, Fink T, Lueker J, Pott A, Heeger C, Chun KRJ. Ablation Strategies for Repeat Procedures in Atrial Fibrillation Recurrences Despite Durable Pulmonary Vein Isolation: The Prospective Randomized ASTRO AF Multicenter Trial. Circulation. 2024 Dec 17;150(25):2007-2018. doi: 10.1161/CIRCULATIONAHA.124.069993. Epub 2024 Oct 7. |
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Number of electrical cardioversions and hospitalizations
| day0 - day 365 |
| Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt am Main | 60431 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| Universitäres Herz- und Gefäßzentrum UKE Hamburg | Hamburg | 20246 | Germany |
| Universitätsklinikum Schleswig Holstein | Lübeck | 23538 | Germany |
| Universitäts Klinikum Ulm | Ulm | 89081 | Germany |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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