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CASTLE-HTx will determine if AF ablation has beneficial effects on mortality in patients with end stage HF who are eligible for HTx
CASTLE-HTx is a randomized evaluation of ablative treatment of AF in patients with severe left ventricular dysfunction who are candidates and eligible for HTx. The primary endpoint is the composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or LVAD implantation. The secondary study endpoints are all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of HF requiring unplanned hospitalization, AF burden reduction, unplanned hospitalization due to cardiovascular reason, all-cause hospitalization, QoL, number of delivered implantable cardioverter-defibrillator (ICD) therapies, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, exercise tolerance, and percentage of right ventricular pacing. Ventricular myocardial tissue will be obtained from patients who will undergo LVAD implantation or HTx to assess the effect of catheter ablation on human HF myocardium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional | No Intervention | ||
| interventional | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial fibrillation ablation | Procedure | Catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality or transplantation | composite of all-cause mortality, worsening of HF requiring a high urgent transplantation or implantation of a ventricular assist device | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum | Bad Oeynhausen | 32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42162774 | Derived | Boettger P, Moersdorf M, Sommer P, Marrouche NF, Costard-Jaeckle A, Crijns HJGM, Bergau L, Fox H, Hindricks G, Dagres N, Schramm R, Fink T, Khalaph M, Sciacca V, Didenko M, Konietschke F, Rudolph V, Gummert J, Tijssen JGP, Sossalla S, Sohns C; CASTLE HTx Investigators. Cost-effectiveness of catheter ablation in end-stage heart failure with atrial fibrillation: Insights from CASTLE-HTx. Heart Rhythm. 2026 May 19:S1547-5271(26)02391-X. doi: 10.1016/j.hrthm.2026.05.024. Online ahead of print. | |
| 37634135 |
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| Derived |
| Sohns C, Fox H, Marrouche NF, Crijns HJGM, Costard-Jaeckle A, Bergau L, Hindricks G, Dagres N, Sossalla S, Schramm R, Fink T, El Hamriti M, Moersdorf M, Sciacca V, Konietschke F, Rudolph V, Gummert J, Tijssen JGP, Sommer P; CASTLE HTx Investigators. Catheter Ablation in End-Stage Heart Failure with Atrial Fibrillation. N Engl J Med. 2023 Oct 12;389(15):1380-1389. doi: 10.1056/NEJMoa2306037. Epub 2023 Aug 27. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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