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NCT Number: NCT04428944

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF:

1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canberra Heart Rhythm Foundation, Garran, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older
  • Patients undergoing first-time ablation procedure for AF
  • Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
  • Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms or any combination of the above
  • Patients whose AF has been refractory to at least one antiarrhythmic drug
  • At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment
  • Patients must be able and willing to provide written informed consent to participate in the study

Exclusion criteria

  • Patients with paroxysmal AF (no episodes lasting > 7 days)
  • Patients with early persistent AF, sustained episode ≤ 3 months
  • Patients with very long lasting persistent AF (episodes lasting > 3 years)
  • Patients with CHA2DS2-VASc score of 0.
  • Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
  • Patients with AF felt to be secondary to an obvious reversible cause
  • Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin
  • Patients with left atrial diameter > 60 mm in the parasternal long axis view
  • Patients who are pregnant

Treatment and study plan

Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)

Procedure

Standard PVI

Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)

Procedure

Standard PVI + Ablation of drivers in LA and RA

Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)

Procedure

Standard PVI + Electrical isolation of the posterior wall of the left atrium

Primary outcomes

  1. Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).

    Time frame: 18 months

Secondary outcomes

  1. Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM

    Time frame: 18 months

  2. Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM

    Time frame: 18 months

  3. Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM

    Time frame: 18 months

  4. Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM

    Time frame: 18 months

  5. Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM

    Time frame: 18 months

  6. Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM

    Time frame: 18 months

  7. Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM

    Time frame: 18 months

  8. Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM

    Time frame: 18 months

  9. Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM

    Time frame: 18 months

  10. Each of the above success measures stratified by CHA2DS2-VASc score

    Time frame: 18 months

  11. Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death

    Time frame: 18 months

  12. Procedure duration

    Time frame: 18 months

  13. Fluoroscopy time (dose)

    Time frame: 18 months

  14. Radiofrequency time

    Time frame: 18 months

  15. Number of repeat procedures

    Time frame: 18 months

  16. Effect of each strategy on AF cycle length changes and AF termination

    Time frame: 18 months

  17. Correlation of acute AF termination on long-term procedural outcome

    Time frame: 18 months

  18. Quality of life measurements during follow-up using AFEQT questionnaire

    Time frame: 6-12-18 months

    AFEQT questionnaires will be used at baseline, 6, 12 and 18 months

  19. Quality of life measurements during follow-up using SF12 questionnaires

    Time frame: 6-12-18 months

    SF36 questionnaires will be used at baseline, 6, 12 and 18 months

  20. Change in AF burden post-ablation procedure (% of time in AF)

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Montreal Heart Institute

Registry information

Official study title

Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study

Acronym: STARAF3

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2020
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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