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Completed

NCT Number: NCT04317911

Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg, Department of Cardiology

Heidelberg, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Arrhythmia recurrence

    Time frame: 12 months

    Clinical arrhythmia and holter-recording

Secondary outcomes

  1. nTproBNP

    Time frame: 12 months

    [ng/L]

  2. Troponin T

    Time frame: 12 months

    [pg/mL]

  3. Systolic left ventricular function in echocardiography

    Time frame: 12 months

    LVEF [%]

  4. Diastolic left ventricular function in echocardiography

    Time frame: 12 months

    E/e'

  5. PA-pressure in echocardiography

    Time frame: 12 months

    [mmHg]

  6. Quality of life questionnaire

    Time frame: 12 months

    SF-36

  7. Diastolic function in stressechocardiography

    Time frame: 12 months

    E/e'

  8. 6-minute-walk-test

    Time frame: 12 months

    [m]

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

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

Acronym: AFFECT

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Mar 23, 2020
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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