Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

Study Overview
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Brief Summary
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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.

Official Title
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Catheter Ablation for Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Catheter Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Left ventricular ejection fraction ≥50% Scheduled for catheter ablation of AF Exclusion Criteria: Significant valvular heart disease Coronary artery disease with >70% stenoses or necessary coronary Intervention at time of recruitment Coronary intervention 60 days before recruitment Coronary bypass surgery 90 days before recruitment Cardiomyopathy or cardiac storage disease (e.g. amyloidosis) Reduced left ventricular ejection fraction Pericardiac disease Significant pulmonary hypertension Chronic obstructive pulmonary disease with home-oxygen-therapy, oral steroids, hospitalization due to exacerbations during the last 12 months before recruitment, or suspected severe pulmonary condition based on clinical evaluation Other non-cardiac conditions associated with limited physical capacity (adipositas permagna, severe anemia) Pregnancy Other limitations for adequate performance of stress echocardiography (e.g. orthopedic reasons)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Catheter Ablation|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia recurrence | Clinical arrhythmia and holter-recording | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nTproBNP | [ng/L] | 12 months | 
| Troponin T | [pg/mL] | 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter Ablation