Atrial FibrillationNCT00367757
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
A study testing Ablate AF triggers via PVI, Substrate via CFAEs and Combined approach for AF ablation in people with Atrial Fibrillation, run by Abbott Medical Devices at 8 sites in 4 countries.
Trial summary
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months terminated by cardioversion or drug). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablate AF triggers via PVI, Substrate via CFAEs and Combined approach for AF ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Aug 2006to Jul 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 or greater.
- "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
- candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
- continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Who cannot join
- chronic atrial fibrillation.
- Patients with AF felt to be secondary to an obvious reversible cause.
- inadequate anticoagulation as defined in the inclusion criteria.
- left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.
- contraindications to systemic anticoagulation with heparin or coumadin.
- previously undergone atrial fibrillation ablation.
- left atrial size > 55 mm.
- Patients who are or may potentially be pregnant
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Canada4 sites
McMaster University
Hamilton, L8L 2X2
Montreal Heaert Institute
Montreal, Quebec, H1T 1C8
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee
Victoria, V8R 4R2
Italy2 sites
Clinica Santa Maria
Bari, Apulia, 70124
Ospedale Regionale Ca'Foncello
Treviso, 31100
About this study
Official title: Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months terminated by cardioversion or drug).
Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation
Read the detailed description
Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF ("substrate"), or a hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted.
Outcomes:
- Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months post-initial procedure.
- Recurrence will be defined by symptoms and/or ECG/Holter data showing AF > 2 mins
- Occurrence of adverse events in each group post-procedure.
- Quality of life assessment at 6 and 12 months post-initial procedure.
Followup:
- 3, 6, and 12 months post-initial procedure.
- Clinical data, ECG, Holter, loop recorder at baseline and at each visit.
- QOL at baseline, 3, 6 and 12 months post-initial procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablate AF triggers via PVI, Substrate via CFAEs, Combined approach for AF ablation
- Keywords
- paroxysmal atrial fibrillation, persistent atrial fibrillation, high burden of atrial fibrillation, atrial fibrillation ablation, Pulmonary vein isolation, AF trigger, complex fractionated electrograms, CFE, CFAE, complex fractionated atrial electrograms, refractory antiarrhythmic medication, PVAI, Ensite NavX, NavX, CoolPath catheter, irrigated ablation catheter, high burden of paroxysmal or persistent atrial fibrillation, candidates for AF ablation, symptomatic AF, AF is refractory to at least one antiarrhythmic medication
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablate AF triggers via PVIProcedure or surgery
Trigger-based ablation guided by pulmonary vein antrum isolation
Substrate via CFAEsProcedure or surgery
Substrate-based ablation using an approach targeting CFAEs
Combined approach for AF ablationProcedure or surgery
Combined trigger and substrate based approach
| Study group | Role | What they receive |
|---|---|---|
| PVI group | Other | Trigger-based ablation guided by pulmonary vein antrum isolation Receives: Procedure: Ablate AF triggers via PVI |
| CFAE group | Other | Substrate-based ablation using an approach targeting CFAEs Receives: Procedure: Substrate via CFAEs |
| Combined group | Other | Combined trigger and substrate based approach Receives: Procedure: Combined approach for AF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
Measured: 3 months
Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.
Measured: 12 months
Secondary outcomes (6)
Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.
Measured: 12 months
Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.
Measured: 12 months
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.
Measured: 12 months
Procedure duration at ablation.
Measured: At intervention
Fluoroscopy time at ablation.
Measured: At intervention
Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atul Verma, Dr., Principal investigator, Southlake Regional health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367757
- Sponsor's protocol ID
- AF06002AF
- Status last verified
- Jan 2019
- First submitted
- 22 Aug 2006
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Verma A, Mantovan R, Macle L, De Martino G, Chen J, Morillo CA, Novak P, Calzolari V, Guerra PG, Nair G, Torrecilla EG, Khaykin Y. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. Eur Heart J. 2010 Jun;31(11):1344-56. doi: 10.1093/eurheartj/ehq041. Epub 2010 Mar 9.
PubMed 20215126
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation
- ClinicalTrials.gov ID
- NCT00367757
- Acronym / sponsor ID
- AF06002AF
- Conditions
- Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, persistent atrial fibrillation, high burden of atrial fibrillation, atrial fibrillation ablation, Pulmonary vein isolation, AF trigger, complex fractionated electrograms, CFE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months terminated by cardioversion or drug).
Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation
Detailed description
Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF ("substrate"), or a hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted.
Outcomes:
- Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months post-initial procedure.
- Recurrence will be defined by symptoms and/or ECG/Holter data showing AF > 2 mins
- Occurrence of adverse events in each group post-procedure.
- Quality of life assessment at 6 and 12 months post-initial procedure.
Followup:
- 3, 6, and 12 months post-initial procedure.
- Clinical data, ECG, Holter, loop recorder at baseline and at each visit.
- QOL at baseline, 3, 6 and 12 months post-initial procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PVI group | Other | Procedure: Ablate AF triggers via PVITrigger-based ablation guided by pulmonary vein antrum isolation |
| CFAE group | Other | Procedure: Substrate via CFAEsSubstrate-based ablation using an approach targeting CFAEs |
| Combined group | Other | Procedure: Combined approach for AF ablationCombined trigger and substrate based approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients age 18 or greater.
- "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
- candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
- continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation.
Key exclusion criteria (8 listed)
- chronic atrial fibrillation.
- Patients with AF felt to be secondary to an obvious reversible cause.
- inadequate anticoagulation as defined in the inclusion criteria.
- left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.
- contraindications to systemic anticoagulation with heparin or coumadin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablate AF triggers via PVITrigger-based ablation guided by pulmonary vein antrum isolation | Procedure or surgery | PVI group |
| Substrate via CFAEsSubstrate-based ablation using an approach targeting CFAEs | Procedure or surgery | CFAE group |
| Combined approach for AF ablationCombined trigger and substrate based approach | Procedure or surgery | Combined group |
Primary outcome
Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
Time frame: 3 months
Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.
Time frame: 12 months
6 secondary outcomes
Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.
Time frame: 12 months
Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.
Time frame: 12 months
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.
Time frame: 12 months
Procedure duration at ablation.
Time frame: At intervention
Fluoroscopy time at ablation.
Time frame: At intervention
Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 20215126Verma A, Mantovan R, Macle L, De Martino G, Chen J, Morillo CA, Novak P, Calzolari V, Guerra PG, Nair G, Torrecilla EG, Khaykin Y. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. Eur Heart J. 2010 Jun;31(11):1344-56. doi: 10.1093/eurheartj/ehq041. Epub 2010 Mar 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Verma, Dr. principal investigator
Southlake Regional health Center
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablate AF triggers via PVI, Substrate via CFAEs and Combined approach for AF ablation in people with Atrial Fibrillation, run by Abbott Medical Devices at 8 sites in 4 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 6 inclusion and 8 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 8 sites in Canada, Italy, Norway, Spain. 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 atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications. (time frame: 3 months). The study lists 2 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 NCT00367757, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 3 Nov 2026.