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Atrial FibrillationHis-PAAFNCT04512586

His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation

A study testing Conduction System pacing and AV node ablation and Atrial fibrillation ablation by pulmonary vein isolation in people with Atrial Fibrillation and Left Atrial Dilatation, run by Region Skane at 4 sites in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least… Read more about this study

Who is it for?
Ages 70 to 85 years
Conditions the study is for
Atrial Fibrillation, Left Atrial Dilatation
What is being tested?
Conduction System pacing and AV node ablation and Atrial fibrillation ablation by pulmonary vein isolation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
4 sitesSweden
Study dates
1 Sep 2020to 26 Feb 2025
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 70 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines
  • LVEF >35%
  • Age 70-85 years
  • Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2)
  • Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist)
  • Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent

Who cannot join

  • Chronic atrial fibrillation with >1 year duration
  • BMI >40kg/m2
  • Hypertrophic cardiomyopathy
  • Severe heart failure with symptoms ≥ NYHA class IIIb
  • Heart amyloidosis
  • Cardiac sarcoidosis
Show all 11Show fewer
  • Recent (<3 months) myocardial infarction
  • Significant heart valve disease (pronounced insufficiency or stenosis)
  • Pacemaker or ICD treatment ongoing, or current pacemaker indication
  • Congenital heart disease that required surgical correction
  • Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Linköping University

    Linköping

  • Skane University Hospital

    Lund, 221 85

  • Stockholm Arrhythmia Center

    Stockholm

  • Varberg Hospital

    Varberg

Other trials in Sweden

About this study

Official title: Physiological Pacemaker Treatment in Combination With AV Node Ablation Compared With Pulmonary Vein Isolation for Patients With Symptomatic Atrial Fibrillation - a Randomized Controlled Study

Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium.

Patient population:

Read more

90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation.

Primary endpoint:

Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation.

Secondary endpoints:

Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.

Being tested
Conduction System pacing and AV node ablation, Atrial fibrillation ablation by pulmonary vein isolation
Keywords
Atrial fibrillation, Left atrial dilatation, Pulmonary vein isolation, AV node ablation, Conduction System pacing, Quality of Life, Age group 70 to 85 years
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • Conduction System pacing and AV node ablationProcedure or surgery

    See study arm description.

  • Atrial fibrillation ablation by pulmonary vein isolationProcedure or surgery

    See study arm description

Study groups in NCT04512586
Study groupRoleWhat they receive
Conduction System pacing plus AV node ablationExperimentalA His-pacing lead in combination with a backup RV pacing lead or an LBB pacing lead, and a right atrial lead (if needed) will be placed using standard technique. The His-pacing or LBB pacing lead will be Medtronic 3830, and the outer sheath will be either Medtronic C304 or C315 deflectable. If failure to implant with these tools, other leads and sheaths can be used at the discretion of the operator. A standard DDD pacemaker or CRT-P device from Medtronic will be used. A minimum of three weeks post-implant, the device will be interrogated and His-bundle threshold will be evaluated. A threshold of ≤2.0V@1.0ms is acceptable. If the device is well-functioning and successful His-pacing is documented, AV node ablation will be performed.
Receives: Procedure: Conduction System pacing and AV node ablation
Pulmonary vein isolationActive comparatorAtrial fibrillation will be performed as a complete pulmonary vein isolation. Either Cryoballon or radio frequency ablation with irrigated tip contact force enabled catheter can be used. Pulsed field ablation can be used if available. Endpoint is complete electrical isolation of all pulmonary veins, verified by entry- and exit block using a multipolar catheter during pacing.
Receives: Procedure: Atrial fibrillation ablation by pulmonary vein isolation

What is being measured

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

  1. Health related Quality of Life: questionnaire

    Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire

    Measured: 12 months

Secondary outcomes (11)

  1. Safety endpoint: Proportion of patients with major adverse events

    Proportion of patients with major adverse events that are devicerelated or related to ablation procedure (including but not limited to exit block, infection, perforation/tamponade, pericardial effusion, lead dislodgement, TIA/stroke, oesophago-atrial fistula, groin hematoma or vascular complication, pseudoaneurysm, phrenic nerve injury).

    Measured: 12 months

  2. Mental Quality of Life: questionnaire

    Improvement of the "mental" health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire

    Measured: 12 months

  3. Arrhythmia related Quality of Life: ASTA questionnaire

    Change in arrhythmia related quality of life as measured by the The Arrhythmia-Specific questionnaire in Tachycardia. The ASTA questionnaire consists of 13 items, each with a score of 0-4. A higher score denotes more symptoms associated with the arrhythmia.

    and Arrhythmia (ASTA) questionnaire

    Measured: 12 months

  4. Anxiety and depression

    Anxiety and depression symptoms, measured by the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 questions with 0 to 3 points for each, with a higher score denoting more depression/anxiety

    Measured: 12 months

  5. Ejection fraction

    Change in left ventricular systolic ejection fraction

    Measured: 12 months

  6. Biomarker for heart failure

    Change in NT-ProBNP level

    Measured: 12 months

  7. Physical performance

    Change in six minute walk test distance

    Measured: 12 months

  8. Electrocardiography changes

    Change in QRS duration on ECG

    Measured: 12 months

  9. Health economy

    Total atrial fibrillation and device related health care cost

    Measured: 12 months

  10. Survival

    Total survival and survival free of major complications

    Measured: 3 years

  11. Hospitalization for heart failure

    Risk of hospitalization for heart failure assessed by Kaplan Meier time dependent analysis using time from ablation to first hospitalization for heart failure within three years

    Measured: 3 years

Timeline

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

  1. First posted13 Aug 2020
  2. Study start1 Sep 2020
  3. Primary completion26 Feb 2025
  4. Study completion26 Feb 2025

Why it stopped: Recruitment too slow. Unrealistic to finish study with full inclusion cohort.

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
Model description
Patients are randomized to either 1. Conduction system pacing via His-pacing electrode, in combination with AV node ablation 2. Pulmonary vein isolation ablation
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04512586
Sponsor's protocol ID
His_PAAF_study
Acronym
His-PAAF
Status last verified
Feb 2024
First submitted
1 Jul 2020
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Conduction System pacing and AV node ablation and Atrial fibrillation ablation by pulmonary vein isolation in people with Atrial Fibrillation and Left Atrial Dilatation, run by Region Skane at 4 sites in Sweden.

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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 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 4 sites in Sweden. 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 was stopped early (reason given: Recruitment too slow. Unrealistic to finish study with full inclusion cohort.). Results are not available in the source record.

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?

Health related Quality of Life: questionnaire (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 NCT04512586.

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 4 Mar 2025.

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His-PAAF Clinical Trial NCT04512586 | AzTrials