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Atrial fibrillation (AF) and atrial tachycardia (AT), including type I atrial flutter, are frequently observed in patients with pulmonary hypertension (PH). Catheter ablation of AF / AT has been established as an effective treatment option in selected patients. However, little is known about the efficacy and safety of this approach in patients with PH. It has also been shown that considerable proportion of patients with PH after acutely successful catheter ablation suffer from the recurrence of clinical or newly manifested arrhythmia. We propose a prospective study to compare two ablation strategies in a randomized fashion: radiofrequency catheter ablation targeting only the clinical arrhythmia versus more extensive substrate-based catheter ablation. This project will investigate the clinical outcome of patients with pulmonary hypertension and symptomatic atrial fibrillation / tachycardia who will be randomly allocated to selective versus complex radiofrequency catheter ablation of arrhythmogenic substrate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Clinical ablation | Active Comparator |
|
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| Group B: Clinical plus substrate-based ablation | Experimental | - The initial ablation steps will be identical to those in patients from Group A. Supplemental ablation will consist of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Procedure | Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia recurrence | Documented arrhythmia recurrence >30 s without antiarrhythmic drugs in post-blanking period after the index ablation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| On-drugs arrhythmia recurrence | Documented on-drugs arrhythmia recurrence | 3 months |
| Symptoms of arrhythmia | Symptoms of arrhythmia by questionare |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FN Olomouc | Olomouc | 77900 | Czechia | |||
| IKEM |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37178136 | Result | Havranek S, Fingrova Z, Skala T, Reichenbach A, Dusik M, Jansa P, Ambroz D, Dytrych V, Klimes D, Hutyra M, Kautzner J, Linhart A, Wichterle D. Catheter ablation of atrial fibrillation and atrial tachycardia in patients with pulmonary hypertension: a randomized study. Europace. 2023 May 19;25(5):euad131. doi: 10.1093/europace/euad131. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| 3 months |
| Change in Quality of life | EQ5D | 6 months |
| Mortality | Mortality of any cause | 3 months |
| Procedure-related complication rate | Complications related to catheter ablation | 1 day (Once) |
| Reablation | Number of repeat catheter ablations if symptoms are ongoing | 3 months |
| Prague |
| 10000 |
| Czechia |
| General University Hospital in Prague | Prague | 12808 | Czechia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D013514 |
| Surgical Procedures, Operative |