Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-26

Study Completion Date

2022-02-28

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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No