Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04317911
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-26
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Primary Completion: 2021-09
• Study Completion: 2022-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arrhythmia recurrence	12 months	Clinical arrhythmia and holter-recording

Secondary Outcome Measures

Name	Time	Method
PA-pressure in echocardiography	12 months	\[mmHg\]
nTproBNP	12 months	\[ng/L\]
Diastolic function in stressechocardiography	12 months	E/e'
Diastolic left ventricular function in echocardiography	12 months	E/e'
Troponin T	12 months	\[pg/mL\]
Systolic left ventricular function in echocardiography	12 months	LVEF \[%\]
Quality of life questionnaire	12 months	SF-36
6-minute-walk-test	12 months	\[m\]

Trial Locations

Locations (1)

University Hospital Heidelberg, Department of Cardiology; 🇩🇪 Heidelberg, Germany