Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction (AFFECT)

October 26, 2022 updated by: Maura Zylla, University Hospital Heidelberg

Catheter Ablation for Atrial Fibrillation in Heart Failure With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • University Hospital Heidelberg, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for evaluation for CA of AF with a left ventricular systolic ejection fraction ≥50% are identified and invited to undergo further stratification. All patients are submitted to thorough clinical screening for signs and symptoms of heart failure, echocardiographic assessment of diastolic function and blood test for peripheral plasma levels of natriuretic peptides. Based on these parameters, patients with heart failure with preserved ejection fraction (HF-PEF) are identified according to current guidelines. Patients not meeting HF-PEF-criteria are included in the control group. Their data and follow-up results are gathered in a registry from which age- and gender-matched controls are extracted for comparison with respective matched HF-PEF-cases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Investigators

  • Principal Investigator: Maura M Zylla, Dr. med., University Hospital Heidelberg, Department of Cardiology (Prof. Dr. H.A. Katus)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 26, 2016

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ACTUAL)

February 1, 2022

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (ACTUAL)

March 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKHD-2-520/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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