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Completed

NCT Number: NCT01203748

Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Andrews War Memorial Hospital, Brisbane, Queensland, 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 age is18 years or greater;
  • Patients undergoing a first-time ablation procedure for AF;
  • Patients with persistent AF;
  • Persistent AF will be defined as a sustained episode lasting > 7 days and less than 3 years.
  • Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
  • At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation;
  • Patients must be able and willing to provide written informed consent to participate in this investigation; and
  • Patients must be willing and able to comply with all peri-ablation and follow-up requirements.

Exclusion criteria

  • Patients with paroxysmal AF;
  • Patients with long-standing persistent AF;
  • 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 contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
  • Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view); and
  • Patients who are pregnant.

Treatment and study plan

PVI + Lines ablation

Procedure

Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)

PVI

Procedure

Pulmonary vein antrum isolation

PVI + CFE ablation

Procedure

Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

Primary outcomes

  1. Freedom from AF

    Time frame: 18 months

    Freedom from documented AF episodes > 30 seconds at 18 months after one or two ablation procedure with/without antiarrhythmic medications (AAD).

    In the CT.gov website and in our protocol, we have stated the above primary endpoint (PE). This was the identical PE used in the original STAR AF I study. The intent of this PE was to present the success rates after both 1 procedure and after 2 procedures separately as was done in the original STAR AF I study. However, this is not entirely clear from the way the PE is stated. It may appear that our PE is the success rate after 2 procedures ("1 or 2" may imply "2"). Since our sample size calculation for the STAR AF II study was based on a single procedure success rate, the single procedure success rate with/without AAD will be used as the PE. The success rate after 2 procedures will be provided as the 1st. secondary endpoint. This clarification is done prior to locking the database and prior to any data analysis.

Secondary outcomes

  1. Freedom from atrial arrhythmia

    Time frame: 18 months

    Freedom from documented atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications

  2. Freedom from atrial flutter and AT

    Time frame: 18 months

    Freedom from documented atrial flutter and atrial tachycardia episodes > 30 seconds at 18 months after one and two procedures with/without antiarrhythmic medications

  3. Freedom from documented or not atrial arrhythmia

    Time frame: 18 months

    Freedom from any atrial arrhythmia (documented or not) episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications

  4. Freedom from symptomatic AF

    Time frame: 18 months

    Freedom from symptomatic AF episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications

  5. Freedom from symptomatic atrial arrhythmia

    Time frame: 18 months

    Freedom from symptomatic atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications

  6. Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death

    Time frame: 18 months

    Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death

  7. Procedure duration and fluoroscopy time

    Time frame: 18 months

    Procedure duration and fluoroscopy time

  8. Number of repeat procedures

    Time frame: 18 months

    Number of repeat procedures

  9. Effect of each strategy on AF cycle length/regularity/termination

    Time frame: 18 months

    Effect of each strategy on AF cycle length/regularity/termination

  10. Relationship of acute termination of AF to long-term procedural outcome

    Time frame: 18 months

    Relationship of acute termination of AF to long-term procedural outcome

  11. Percentage achievement of complete linear block in linear ablation arm

    Time frame: 18 months

    Percentage achievement of complete linear block in linear ablation arm

  12. Effect of complete linear block on procedural outcome in linear ablation arm

    Time frame: 18 months

    Effect of complete linear block on procedural outcome in linear ablation arm

  13. Quality of life measurements (SF-36, EQ-5D and CCS SAF)

    Time frame: 18 MONTHS

    Quality of life measurements (SF-36, EQ-5D and CCS SAF) at baseline, 6, 12 and 18 months after one and/or two ablation procedures

  14. Correlation of AF burden to symptoms and quality of life changes

    Time frame: 18 Months

    Correlation of AF burden to symptoms and quality of life changes

  15. Improvement in AF burden by > 90% post ablation procedure

    Time frame: 18 months

    Improvement in AF burden by > 90% post ablation procedure

  16. Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome

    Time frame: 18 months

    Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome

  17. Cut off of AF burden that affects the Quality of Life measurement

    Time frame: 18 months

    Cut off of AF burden that affects the Quality of Life measurement

  18. Evaluation of cost utility

    Time frame: 18 months

    Evaluation of cost utility

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: Star AF II

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2010
Registry last updated
Jan 30, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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