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Atrial FibrillationStar AF IINCT01203748

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

A study testing PVI + Lines ablation, PVI and PVI + CFE ablation in people with Atrial Fibrillation, run by Abbott Medical Devices at 2 sites in 2 countries.

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

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… 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?
PVI + Lines ablation, PVI and PVI + CFE ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
589 participants
Where
2 sitesin 2 countries
Study dates
Nov 2010to Jan 2014
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Australia1 site

  • St. Andrews War Memorial Hospital

    Brisbane, Queensland

Other trials in Australia

Canada1 site

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 8C3

Other trials in Canada

About this 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.

Being tested
PVI + Lines ablation, PVI, PVI + CFE ablation
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • PVI + Lines ablationProcedure or surgery

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

  • PVIProcedure or surgery

    Pulmonary vein antrum isolation

  • PVI + CFE ablationProcedure or surgery

    Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

Study groups in NCT01203748
Study groupRoleWhat they receive
PVI + Lines AblationExperimentalNot described
Receives: Procedure: PVI + Lines ablation
PVI AblationActive comparatorNot described
Receives: Procedure: PVI
PVI + CFEExperimentalNot described
Receives: Procedure: PVI + CFE ablation

What is being measured

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

  1. Freedom from AF

    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.

    Measured: 18 months

Secondary outcomes (18)

  1. Freedom from atrial arrhythmia

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

    Measured: 18 months

  2. Freedom from atrial flutter and AT

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

    Measured: 18 months

  3. Freedom from documented or not atrial arrhythmia

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

    Measured: 18 months

  4. Freedom from symptomatic AF

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

    Measured: 18 months

  5. Freedom from symptomatic atrial arrhythmia

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

    Measured: 18 months

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

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

    Measured: 18 months

  7. Procedure duration and fluoroscopy time

    Procedure duration and fluoroscopy time

    Measured: 18 months

  8. Number of repeat procedures

    Number of repeat procedures

    Measured: 18 months

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

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

    Measured: 18 months

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

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

    Measured: 18 months

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

    Percentage achievement of complete linear block in linear ablation arm

    Measured: 18 months

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

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

    Measured: 18 months

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

    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

    Measured: 18 MONTHS

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

    Correlation of AF burden to symptoms and quality of life changes

    Measured: 18 Months

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

    Improvement in AF burden by > 90% post ablation procedure

    Measured: 18 months

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

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

    Measured: 18 months

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

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

    Measured: 18 months

  18. Evaluation of cost utility

    Evaluation of cost utility

    Measured: 18 months

Timeline

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

  1. First posted16 Sep 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2014
  4. Study completionJan 2014

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
Participant
Enrolment
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01203748
Sponsor's protocol ID
AF-09-102-ID-AB
Acronym
Star AF II
Status last verified
Jan 2019
First submitted
15 Sep 2010
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Terricabras M, Mantovan R, Jiang CY, Betts TR, Chen J, Deisenhofer I, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A; Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II) Investigators. Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2025473. doi: 10.1001/jamanetworkopen.2020.25473.

    PubMed 33275151

  • Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

    PubMed 25946280

  • Verma A, Sanders P, Macle L, Deisenhofer I, Morillo CA, Chen J, Jiang CY, Ernst S, Mantovan R. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II): design and rationale. Am Heart J. 2012 Jul;164(1):1-6.e6. doi: 10.1016/j.ahj.2012.04.002.

    PubMed 22795275

Questions about this trial

What is this clinical trial studying?

A study testing PVI + Lines ablation, PVI and PVI + CFE ablation in people with Atrial Fibrillation, run by Abbott Medical Devices at 2 sites in 2 countries.

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 8 inclusion and 7 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia, Canada. 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?

Freedom from AF (time frame: 18 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 NCT01203748, which also lists 3 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 30 Jan 2019.

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