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Atrial FibrillationAFFECTNCT04317911

Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

An observational study of Atrial Fibrillation, run by University Hospital Heidelberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Catheter Ablation
How many people
102 participants
Where
1 siteGermany
Study dates
26 Jan 2016to Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • Left ventricular ejection fraction ≥50%
  • Scheduled for catheter ablation of AF

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Heidelberg, Department of Cardiology

    Heidelberg

Other trials in Germany

About this study

Official title: 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.

Being tested
Catheter Ablation
Keywords
Catheter Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter AblationOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arrhythmia recurrence

    Clinical arrhythmia and holter-recording

    Measured: 12 months

Secondary outcomes (8)

  1. nTproBNP

    [ng/L]

    Measured: 12 months

  2. Troponin T

    [pg/mL]

    Measured: 12 months

  3. Systolic left ventricular function in echocardiography

    LVEF [%]

    Measured: 12 months

  4. Diastolic left ventricular function in echocardiography

    E/e'

    Measured: 12 months

  5. PA-pressure in echocardiography

    [mmHg]

    Measured: 12 months

  6. Quality of life questionnaire

    SF-36

    Measured: 12 months

  7. Diastolic function in stressechocardiography

    E/e'

    Measured: 12 months

  8. 6-minute-walk-test

    [m]

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start26 Jan 2016
  3. Primary completionSep 2021
  4. Study completionFeb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317911
Sponsor's protocol ID
UKHD-2-520/2015
Acronym
AFFECT
Status last verified
Oct 2022
First submitted
13 Mar 2020
Last updated
27 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zylla MM, Leiner J, Rahm AK, Hoffmann T, Lugenbiel P, Schweizer P, Scholz E, Mereles D, Kronsteiner D, Kieser M, Katus HA, Frey N, Thomas D. Catheter Ablation of Atrial Fibrillation in Patients With Heart Failure and Preserved Ejection Fraction. Circ Heart Fail. 2022 Sep;15(9):e009281. doi: 10.1161/CIRCHEARTFAILURE.121.009281. Epub 2022 Jun 21.

    PubMed 36126143

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by University Hospital Heidelberg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arrhythmia recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317911, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.

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