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Atrial Fibrillation (AF)ExPAFNCT07008066

Exercise-induced Cardioversion in Persistent Atrial Fibrillation

A study testing Bicycle ergometer excercise in people with Atrial Fibrillation (AF), run by Uppsala University at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to to evaluate the feasibility of conducting a larger randomized controlled trial (RCT) to assess whether an exercise stress test on an ergometer bicycle could induce sinus rhythm in patients with persistent AF scheduled for electrical cardioversion and if this intervention (regardless of rhythm… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Bicycle ergometer excercise
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSweden
Study dates
1 Sep 2025to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (18-75 years) with persistent AF
  • planned for EC
  • with at least 3 weeks of therapeutic oral anticoagulation before intervention

Who cannot join

  • Unable to perform a symptom limited cycle exercise test
  • Ischemic heart disease
  • Heart failure
  • Severe valvular disease
  • Unable to speak and write Swedish language
  • Unable to provide written, informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden1 site
  • Centre for Clinical Research, Uppsala University, Västmanland County Hospital

    Västerås, SE-72189

Other trials in Sweden

About this study

Official title: Exercise-induced Cardioversion in Persistent Atrial Fibrillation (ExPAF): A Feasibility Pilot Study

This study aims to to evaluate the feasibility of conducting a larger randomized controlled trial (RCT) to assess whether an exercise stress test on an ergometer bicycle could induce sinus rhythm in patients with persistent AF scheduled for electrical cardioversion and if this intervention (regardless of rhythm conversion) could improve health-related quality of life in these patients.

Read the detailed description

Atrial fibrillation (AF) is one of the most common heart rhythm disorders worldwide. The estimated prevalence of AF in Europe is approximately 2% in the general population and increases with age, reaching 16-24% in individuals aged > 85 years. AF is significantly associated with an increased risk of heart failure, ischemic stroke, cognitive impairment, vascular dementia, and death. Aside from patient suffering, AF is a large economic burden for the healthcare system, where hospitalization is the major driver, accounting for 50-70% of the annual direct costs. Management of patients with AF is multifaceted. The main components include comorbidity and risk factor management (targeting hypertension, diabetes, heart failure), avoidance of stroke and thromboembolism, and reduction of symptoms through rate and rhythm control.

AF episodes may terminate spontaneously, and if they do so within seven days, they are classified as paroxysmal AF. Persistent AF is defined as AF episodes that are not self-terminating. Rhythm control, which involves restoring and maintaining sinus rhythm, is an important part of the management of patients with atrial fibrillation, where the main reason is to reduce symptoms of AF. One alternative treatment is electrical cardioversion (EC), which involves delivering low-energy shocks to the heart in a sedated patient to restore a normal sinus rhythm. A poorly tested alternative to EC in cardioversion is to physically increase the heart rate. In a small observational study, Gates et al. included 18 patients with AF scheduled for EC. The patients underwent a treadmill exercise test, and five (27.8%) converted to sinus rhythm during exercise. None of the patients who failed to convert to sinus rhythm with exercise did so spontaneously before electrical conversion 3 hours to 7 months later. Exercise tests are considered safe when contraindications are adhered to, termination criteria are observed, and appropriately trained personnel administer the tests.

Although EC is effective, it involves hospitalization, anesthesia, and the associated costs and risks. If exercise testing proves to be effective for converting AF to sinus rhythm, it could improve arrhythmia management by offering a non-invasive, cost-effective alternative that empowers patients to manage their condition through home-based programs. This approach not only would reduce hospital dependence and healthcare costs but also enhance cardiovascular fitness and overall quality of life.

Being tested
Bicycle ergometer excercise, Standard care with electrical cardioversion
Keywords
Exercise Testing, Persistent Atrial Fibrillation, Electrical Cardioversion, Arrhythmia
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

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

  • Bicycle ergometer excerciseOther

    Patients will undergo a symptom-limited ergometer cycling test under medical supervision. If the atrial fibrillation is not converted to sinus rhythm during the exercise test, the patients will be electrically converted.

  • Standard care with electrical cardioversionProcedure or surgery

    Standard care with planned electrical cardioversion without exercise intervention.

Study groups in NCT07008066
Study groupRoleWhat they receive
Exercise groupExperimentalPatients will undergo a symptom-limited ergometer cycling test under medical supervision. If the atrial fibrillation is not converted to sinus rhythm during the exercise test, the patients will be electrically converted.
Receives: Other: Bicycle ergometer excercise
Control groupActive comparatorStandard care with planned electrical cardioversion without exercise intervention.
Receives: Procedure: Standard care with electrical cardioversion

What is being measured

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

  1. Feasibility of the pilot study - Recruitment rate

    Number of patients asked to participate in the study

    Measured: Day 1

  2. Feasibility of the pilot study - Consent rate

    Number of patients giving written consent to participate in the study

    Measured: Day 1

  3. Feasibility of the pilot study - Participant fidelity

    Ability of participants to comply with the intervention protocol.

    Measured: From enrollment to the end of assessments, an average of 2 months

  4. Feasibility of the pilot study - Study retention

    Participants dropout rates.

    Measured: Through study completion, an average of 6 months

  5. Feasibility of the pilot study - Adverse events

    Side effects and adverse events during the study

    Measured: Through study completion, an average of 6 months

Secondary outcomes (3)
  1. AF conversion to sinus rhythm

    Rate of AF conversion to sinus rhythm immediately after intervention

    Measured: Immediately after exercise or electrical conversion

  2. Atrial fibrillation-related quality of life

    Atrial fibrillation-related quality of life, as measured by the AFEQT score.

    Measured: At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)

  3. Overall health-related quality of life

    Overall health-related quality of life, as measured by the EQ VAS (0-100) scale (from EQ5D-5L).

    Measured: At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)

Timeline

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

  1. First posted6 Jun 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07008066
Sponsor's protocol ID
2025-01883-01
Other IDs
2025
Acronym
ExPAF
Status last verified
May 2025
First submitted
23 Apr 2025
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Holmes DN, Piccini JP, Allen LA, Fonarow GC, Gersh BJ, Kowey PR, O'Brien EC, Reiffel JA, Naccarelli GV, Ezekowitz MD, Chan PS, Singer DE, Spertus JA, Peterson ED, Thomas L. Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005358. doi: 10.1161/CIRCOUTCOMES.118.005358.

    PubMed 31092022
  • Gibbons L, Blair SN, Kohl HW, Cooper K. The safety of maximal exercise testing. Circulation. 1989 Oct;80(4):846-52. doi: 10.1161/01.cir.80.4.846.

    PubMed 2791248
  • Atterhog JH, Jonsson B, Samuelsson R. Exercise testing: a prospective study of complication rates. Am Heart J. 1979 Nov;98(5):572-9. doi: 10.1016/0002-8703(79)90282-5.

    PubMed 495403
  • Gates P, Al-Daher S, Ridley D, Black A. Could exercise be a new strategy to revert some patients with atrial fibrillation? Intern Med J. 2010 Jan;40(1):57-60. doi: 10.1111/j.1445-5994.2009.01940.x.

    PubMed 19383061
  • Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.

    PubMed 39210723
  • Wolowacz SE, Samuel M, Brennan VK, Jasso-Mosqueda JG, Van Gelder IC. The cost of illness of atrial fibrillation: a systematic review of the recent literature. Europace. 2011 Oct;13(10):1375-85. doi: 10.1093/europace/eur194. Epub 2011 Jul 14.

    PubMed 21757483
  • Dai H, Zhang Q, Much AA, Maor E, Segev A, Beinart R, Adawi S, Lu Y, Bragazzi NL, Wu J. Global, regional, and national prevalence, incidence, mortality, and risk factors for atrial fibrillation, 1990-2017: results from the Global Burden of Disease Study 2017. Eur Heart J Qual Care Clin Outcomes. 2021 Oct 28;7(6):574-582. doi: 10.1093/ehjqcco/qcaa061.

    PubMed 32735316
  • Mobley AR, Subramanian A, Champsi A, Wang X, Myles P, McGreavy P, Bunting KV, Shukla D, Nirantharakumar K, Kotecha D. Thromboembolic events and vascular dementia in patients with atrial fibrillation and low apparent stroke risk. Nat Med. 2024 Aug;30(8):2288-2294. doi: 10.1038/s41591-024-03049-9. Epub 2024 Jun 5.

    PubMed 38839900
  • Koh YH, Lew LZW, Franke KB, Elliott AD, Lau DH, Thiyagarajah A, Linz D, Arstall M, Tully PJ, Baune BT, Munawar DA, Mahajan R. Predictive role of atrial fibrillation in cognitive decline: a systematic review and meta-analysis of 2.8 million individuals. Europace. 2022 Sep 1;24(8):1229-1239. doi: 10.1093/europace/euac003.

    PubMed 35061884
  • Bassand JP, Accetta G, Al Mahmeed W, Corbalan R, Eikelboom J, Fitzmaurice DA, Fox KAA, Gao H, Goldhaber SZ, Goto S, Haas S, Kayani G, Pieper K, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation. PLoS One. 2018 Jan 25;13(1):e0191592. doi: 10.1371/journal.pone.0191592. eCollection 2018.

    PubMed 29370229
  • Ruddox V, Sandven I, Munkhaugen J, Skattebu J, Edvardsen T, Otterstad JE. Atrial fibrillation and the risk for myocardial infarction, all-cause mortality and heart failure: A systematic review and meta-analysis. Eur J Prev Cardiol. 2017 Sep;24(14):1555-1566. doi: 10.1177/2047487317715769. Epub 2017 Jun 15.

    PubMed 28617620
  • Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ. 2016 Sep 6;354:i4482. doi: 10.1136/bmj.i4482.

    PubMed 27599725
  • Krijthe BP, Kunst A, Benjamin EJ, Lip GY, Franco OH, Hofman A, Witteman JC, Stricker BH, Heeringa J. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013 Sep;34(35):2746-51. doi: 10.1093/eurheartj/eht280. Epub 2013 Jul 30.

    PubMed 23900699

Questions about this trial

What is this clinical trial studying?

A study testing Bicycle ergometer excercise in people with Atrial Fibrillation (AF), run by Uppsala University at 1 site 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Jun 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Pär Hedberg, M.D., Ph.D. (+46 21 175177, par.hedberg@uu.se; par.o.hedberg@regionvastmanland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the pilot study - Recruitment rate (time frame: Day 1). The study lists 5 primary outcomes in all. 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 NCT07008066, which also lists 13 linked publications.

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 6 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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