Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cardialysis BV | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Procedure | Experimental | Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure. |
|
| Catheter Procedure | Active Comparator | Standard catheter ablation with pulmonary vein (PV) isolation (minimum lesion set) and optional additional lesions (index procedure). When required due to AF recurrence, ablation may be repeated within 6 months after the index-procedure according to clinical indications and consistent with the Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Consensus Statement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriCure Bipolar System | Device |
| ||
| Standard Endocardial Ablation with Catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs). | Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects free from documented AF, AFL or AT episodes > 30 seconds in duration through 24 and 36 months follow-up, in the absence of Class I or III AADs. | Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite major complications | Up to 180 days (6-months) post index procedure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Tomáš Ostřížek | Brno | Czechia | ||||
| Czech Budejovice Hospital, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40711852 | Derived | Doll N, Weimar T, Kosior DA, Bulava A, Mokracek A, Monnig G, Sahu J, Hunter S, Wijffels M, van Putte B, Rub N, Nemec P, Ostrizek T, Fransen E, Suwalski P. Durable effectiveness and safety of hybrid ablation versus catheter ablation: 2-year results from the randomized CEASE-AF trialdagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf146. doi: 10.1093/ejcts/ezaf146. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| AtriClip® PRO LAA Exclusion System | Device |
|
| Endocardial Ablation with Catheter | Device |
|
| Repeated Endocardial ablation(s) | Device |
|
| České Budějovice |
| Czechia |
| Cardiovascular Center Bad Neustadt | Bad Neustadt an der Saale | Germany |
| Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück | Bad Rothenfelde | Germany |
| Heart Center Leipzig | Leipzig | Germany |
| Klinikum Ludwigsburg | Ludwigsburg | Germany |
| Peter Osypka Heart Center Munich | Munich | Germany |
| Kliniken Sindelfingen | Sindelfingen | Germany |
| Sana Heart Center Stuttgart | Stuttgart | Germany |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| Central Clinical Hospital of the Ministry of Interior | Warsaw | Poland |
| Northern General Hospital | Sheffield | United Kingdom |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided