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Atrial FibrillationNURSECAT-AFNCT05333445

NURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation

A study testing educational program, risk factors management and telephone and e-mail contact in people with Atrial Fibrillation, run by Hospital Clinic of Barcelona at 1 site in Spain.

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

The study aims to examine the effect of nurse-led education program on quality of life, atrial fibrillation (AF) risk factors, AF symptomatology, arrhythmia recurrence rate, and readmission rate after AF catheter ablation. 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?
educational program, risk factors management and telephone and e-mail contact
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSpain
Study dates
15 Apr 2022to 30 Apr 2024
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Derivatives from the outpatient clinic of the center itself, as well as patients referred from other centers that have ours as a reference for a first AF ablation procedure.
  • Have signed the informed consent.

Who cannot join

  • Patients with cognitive impairment or disorientation.
  • Patients with problems of comprehension or expression of Spanish or Catalan.
  • Patients who are part of the medical or nursing group.
  • Patient with defined heart failure with a left ventricular ejection fraction (LVEF) less than 40% and a NYHA III or IV.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínic

    Barcelona, barcelona, 08028

Other trials in Spain

About this study

Official title: Assessing the Nurse-led Educational Intervention in Patients Undergoing Catheter Ablation for Atrial Fibrillation: a Randomized Controlled Trial

The study aims to examine the effect of nurse-led education program on quality of life, atrial fibrillation (AF) risk factors, AF symptomatology, arrhythmia recurrence rate, and readmission rate after AF catheter ablation.

Being tested
educational program, risk factors management, telephone and e-mail contact, usual care
Keywords
atrial fibrillation, nurse-led, educational intervention, risk factors, quality of life
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • educational programBehavioural

    Education for the management of AF is carried out in a structured way, following the Bowyer model using the following pre-specified subtitles: "How the heart works"; "Causes and risk factors of AF"; "Symptoms of AF";"" Goals of treatment in atrial fibrillation ""; ''preparation for the ablation procedure''; and "Lifestyle Modification". The technique consists of discussing the main subtitles and adapting the visit line to the needs of each patient

  • risk factors managementBehavioural

    identify risk factors and offer guidance based on management strategies for the specific risk factor in each case

  • telephone and e-mail contactBehavioural

    patients will also be provided with a phone number and email to contact the nurse for any concerns outside the designated times within the twelve-month follow-up.

  • usual careOther

    standard care

Study groups in NCT05333445
Study groupRoleWhat they receive
Nursing interventionExperimentalThe NI will be performed at 3 times: face to face between 21 and 7 days before admission, between 7 and 15 days after the date of ablation, and 6 months after the ablation procedure.
Receives: Behavioral: educational program; Behavioral: risk factors management; Behavioral: telephone and e-mail contact
control groupActive comparatorAfter hospital discharge, all patients will be referred to their primary care physician or cardiologist for follow-up. Patients will receive standard follow-up checks by the medical team will not receive structured education from the nurse.
Receives: Other: usual care

What is being measured

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

  1. changes from the baseline and better score in the validated ASTA questionnaire of the intervention group compared to the control group at 12 months in quality of life of patients .

    We will use the second part of ASTA questionnaire: it consists of 13 questions and the answers are measured using a Likert frequency scale from "Never = 0" to "Always = 4". Higher scores on this scale represent poorer quality of life.

    Measured: 12 months

Secondary outcomes (7)

  1. number of patients who have the AF risk factor within normal parameters

    differences between the two groups in number of patients with BMI and/or waist circumference changes from the baseline, better score on the Minnesota Adapted Scale for Physical Exercise, number of patients who do not smoke or drink alcohol, number of patients with positive polysomnography, number of patients with impaired of the analytical parameters of HbA1c, TSH, LDL or Triglycerides.

    Measured: 12 months

  2. number of participants with re-hospitalisation or emergency room visits for cardiovascular cause

    differences between the two groups in number of patients who come to the emergency room or re-admit after discharge from catheter ablation.

    Measured: 12 months

  3. number of participants with recurrences at AF rhythm

    number of AF detected by ECG or 24-hour cardiac holter routine at 3, 6 and 12 months.

    Measured: 12 months

  4. differences between both groups in the score received by the patients in the User Experience Questionnaire based on the Picker-33 Patient Experience Questionnaire

    It consists of 14 closed-ended questions and is performed using a checklist to assign numerical values to subjective satisfaction using a Likert scale from "No = 0" to "Yes, always = 4". Higher scores on this scale represent greater satisfaction. An open question has been added so that participants can add their suggestions

    Measured: 3 months

  5. Differences between both groups in intensity, frequency and severity of symptoms related to AF evaluated with the validated ASTA questionnaire

    differences between both groups in the score obtained in the first part of the validated questionnaire in Spanish and English sensitive for patients with AF. It will be self-filled by the patient himself. It consists of 8 questions formulated in 3 different ways: (1) Multiple correct answer multiple choice questions. (2) Multiple choice questions with only one correct answer. (3) Checklist for assigning numerical values to frequency using a Likert scale from "Never = 0" to "Always = 4". Higher scores on this scale represent greater severity of symptoms.

    Measured: 12 months

  6. differences between both groups in the score obtained in the adapted AFKAT questionnaire patient's knowledge of AF.

    differences between both groups in the Level of knowledge of FA through the AFKAT questionnaire validated in English but adapted and translated into Spanish by our team. It consists of 25 questions with dichotomous True/False answers. The more true answers, the better knowledge the participant has.

    Measured: 3 months

  7. calls and emails received

    Quantify the calls and emails received from patients to the FA nurse.

    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 posted19 Apr 2022
  2. Study start15 Apr 2022
  3. Primary completion1 Mar 2024
  4. Study completion30 Apr 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05333445
Sponsor's protocol ID
NURSECAT-AF
Acronym
NURSECAT-AF
Status last verified
Jan 2024
First submitted
25 Mar 2022
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cano-Valls A, Martinez Monblan MA, Carro-Fernandez E, Niebla M, Domingo R, Hevia-Puyo S, Venturas-Nieto M, Borras R, Tolosana JM, Porta-Sanchez A, Guichard JB, Althoff TF, Roca-Luque I, Mont L, Guasch E. NURSE-Led Care in Patients Undergoing Catheter Ablation for Atrial Fibrillation: The NURSECAT-AF Randomized Trial. Circ Arrhythm Electrophysiol. 2026 Mar;19(3):e014149. doi: 10.1161/CIRCEP.125.014149. Epub 2026 Feb 26.

    PubMed 41744095

Questions about this trial

What is this clinical trial studying?

A study testing educational program, risk factors management and telephone and e-mail contact in people with Atrial Fibrillation, run by Hospital Clinic of Barcelona at 1 site in Spain.

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 4 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 7 Mar 2025. 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 Spain. 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?

changes from the baseline and better score in the validated ASTA questionnaire of the intervention group compared to the control group at 12 months in quality of life of patients . (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 NCT05333445, 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 7 Mar 2025.

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