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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
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Atrial fibrillation (AF) displays high prevalence in heart failure with preserved ejection fraction (HF-PEF) and compromises prognosis of affected patients. This study aims to assess catheter ablation (CA) for AF in patients with HF-PEF compared to AF-patients without systolic or diastolic dysfunction. Primary endpoints are freedom from AF and quality of life at 1 year. Furthermore, the study is designed to elucidate mechanistic characteristics distinguishing arrhythmic substrate and predicting AF-recurrence in patients with HF-PEF. For this purpose, left atrial concentrations of biomarkers for inflammation, fibrosis and neurohumoral activation are determined and hemodynamic measurements are performed periprocedurally.
Information on benefit from CA in these patients is necessary for clinical decision making and mechanistic investigations may point to tailored approaches in order to increase therapeutic efficiency.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Other | Patients with preserved ejection fraction presenting for catheter ablation via of atrial fibrillation are included in this study and prospectively observed regarding arrhythmia-related, functional and biomarker-associated outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia recurrence | Clinical arrhythmia and holter-recording | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| nTproBNP | [ng/L] | 12 months |
| Troponin T | [pg/mL] | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting for evaluation for CA of AF with a left ventricular systolic ejection fraction ≥50% are identified and invited to undergo further stratification. All patients are submitted to thorough clinical screening for signs and symptoms of heart failure, echocardiographic assessment of diastolic function and blood test for peripheral plasma levels of natriuretic peptides. Based on these parameters, patients with heart failure with preserved ejection fraction (HF-PEF) are identified according to current guidelines. Patients not meeting HF-PEF-criteria are included in the control group. Their data and follow-up results are gathered in a registry from which age- and gender-matched controls are extracted for comparison with respective matched HF-PEF-cases.
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| Name | Affiliation | Role |
|---|---|---|
| Maura M Zylla, Dr. med. | University Hospital Heidelberg, Department of Cardiology (Prof. Dr. H.A. Katus) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Heidelberg, Department of Cardiology | Heidelberg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36126143 | Derived | Zylla MM, Leiner J, Rahm AK, Hoffmann T, Lugenbiel P, Schweizer P, Scholz E, Mereles D, Kronsteiner D, Kieser M, Katus HA, Frey N, Thomas D. Catheter Ablation of Atrial Fibrillation in Patients With Heart Failure and Preserved Ejection Fraction. Circ Heart Fail. 2022 Sep;15(9):e009281. doi: 10.1161/CIRCHEARTFAILURE.121.009281. Epub 2022 Jun 21. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| 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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Blood samples
| Systolic left ventricular function in echocardiography |
LVEF [%] |
| 12 months |
| Diastolic left ventricular function in echocardiography | E/e' | 12 months |
| PA-pressure in echocardiography | [mmHg] | 12 months |
| Quality of life questionnaire | SF-36 | 12 months |
| Diastolic function in stressechocardiography | E/e' | 12 months |
| 6-minute-walk-test | [m] | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |