Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

Atrial Fibrillation Clinical Trial

— AFFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317911
• Other study ID #: UKHD-2-520/2015
• Status: Completed
• Start date: January 26, 2016
• Est. completion date: February 2022

Study information

• Verified date: October 2022
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2022
• Est. primary completion date: September 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg, Department of Cardiology	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia recurrence	Clinical arrhythmia and holter-recording	12 months
Secondary	nTproBNP	[ng/L]	12 months
Secondary	Troponin T	[pg/mL]	12 months
Secondary	Systolic left ventricular function in echocardiography	LVEF [%]	12 months
Secondary	Diastolic left ventricular function in echocardiography	E/e'	12 months
Secondary	PA-pressure in echocardiography	[mmHg]	12 months
Secondary	Quality of life questionnaire	SF-36	12 months
Secondary	Diastolic function in stressechocardiography	E/e'	12 months
Secondary	6-minute-walk-test	[m]	12 months