Atrial FibrillationROC-STARNCT04442113
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
A study testing Pulmonary vein isolation plus ablation guided by novel STAR mapping™ and Pulmonary vein isolation in people with Atrial Fibrillation, run by Rhythm AI Ltd.
Trial summary
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation plus ablation guided by novel STAR mapping™ and Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Sep 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent AF (continuous AF duration between 1 week and 24 months)
- No previous AF ablation or other left atrial ablation
- Undergoing a clinical AF ablation procedure.
Who cannot join
- Unwillingness to sign consent
- Any other contraindication to catheter ablation
- Age <18 years or > 80 years
- AF with a reversible cause
- AF that is paroxysmal
- AF that has been persistent > 2 yrs
Show all 17Show fewer
- Previous left atrial ablation (percutaneous or surgical)
- Severe LV impairment (EF < 40%)
- NYHA class 3 or 4 heart failure
- Severely dilated left atrium (LA diameter > 50 mm)
- Known cardiomyopathy or inherited 'channelopathy'
- Congential heart disease (excluding PFO)
- More than moderate valvular heart disease or prosthetic heart valves
- Prior MI, PCI or cardiac surgery in the last 6 months
- Pregnancy
- Morbid obesity (defined as BMI >40)
- Any other medical problem likely to cause death within the next 18 months
About this study
Official title: Multicenter Randomized Controlled Trial Assessing Targeted Ablation in Persistent Atrial Fibrillation Using the Stochastic Trajectory Analysis of Ranked Signals (STAR Mapping™) Method.
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity. Catheter ablation is a safe treatment which is effective for paroxysmal AF but the success rate for persistent AF remains approximately 50% at 1 year. A new mapping technique, called Stochastic Trajectory Analysis of Ranked signals (STAR Mapping™) Method, has recently been developed. In a pilot study, localised sources driving AF were consistently mapped and ablated with excellent acute and long term outcomes. This trial will test the clinical effectiveness of this approach by comparing conventional ablation with pulmonary vein isolation (PVI) to PVI plus STAR mapping™ guided ablation. We plan to test this through a prospective multicenter randomized controlled trial including 177 patients.
Read the detailed description
This will be a prospective multi-centre randomised controlled trial with two treatment arms. We plan to include up to 15 UK centres. Patients that have been referred for catheter ablation of symptomatic persistent AF will be recruited. Patients will be consented and have their baseline review after having been listed for AF ablation on the hospital waiting list. They will be randomized to one of two treatment arms. All patients will undergo their procedure using a 3D mapping system. Standard catheters will be used during the ablation procedure. Because the STAR mapping™ system will be configured for use with a special version of the 3D mapping system Carto (BIosense Webster) the study will mandate use of clinically approved Carto catheters: Smarttouch thermocool ablation catheter and the Pentarray mapping catheter. Ablation procedures will be carried out using the usual policies and protocols of the institutions involved except for the specific points below. The two treatment arms include:
- Control arm - PVI alone After PVI, no further ablation in AF will be allowed. If the patient organizes into an atrial tachycardia (AT) during PVI this will be mapped and ablated. Otherwise, in accordance with common clinical practice, a 30 minute waiting period will be observed following PVI to watch for acute pulmonary vein reconnection. During this waiting period, mapping data will be acquired using the multipolar pulmonary vein mapping catheter to acquire STAR mapping™ data. The operator will be blinded to these data. This is done using the pentarray mapping catheter to acquire a minimum of 10 widely spaced globally distributed left atrial recordings of 30 seconds each outside the pulmonary veins. If the patient has remained in AF post PVI then electrical cardioversion will be performed, the pulmonary veins checked and re-isolated if needed, and the procedure terminated.
- Experimental arm - PVI followed by STAR guided ablation. If the patient organises to sinus rhythm after PVI alone then a 30 minute wait will be observed to ensure sustained PVI and the procedure terminated. If patients remain in AF following PVI, the left atrium will be mapped using a multipolar mapping catheter to acquire a minimum of 10 widely spaced globally distributed recordings outside the pulmonary veins. STAR mapping™ data will be exported and maps generated. Ablation will then be targeted at the leading sites identified by STAR mapping™ in order of ranking (1st first, 2nd second, etc.) with the end-point of AF termination. If AF terminates further sites will not be targeted. If patients terminate to an atrial tachycardia then this will be mapped and ablated as per standard clinical practice.
If AF persists following ablation of all STAR mapping™ identified sites then mapping of the right atrium may be considered if the septum consistently activates early and the coronary sinus activation is predominantly proximal to distal, and further ablation permitted in the right atrium if indicated. If patients remain in AF following ablation then they will be electrically cardioverted.
Follow-up All patients will undergo 12 months follow-up with an ECG at 3, 6, 9 and 12 months, and a 48h ambulatory Holter monitor at 6 and 12 months. Patients will routinely continue anti-arrhythmic therapy for up to 3 months post procedure which will be considered a blanking period. After 3 months rhythmically active antiarrhythmic drugs will be stopped.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation plus ablation guided by novel STAR mapping™, Pulmonary vein isolation
- Keywords
- Atrial Fibrillation, Catheter ablation, Arrhythmia, Cardiac mapping
- 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.
Pulmonary vein isolation plus ablation guided by novel STAR mapping™Procedure or surgery
Catheter ablation for persistent AF consisting of pulmonary vein isolation plus additional ablation guided by the novel STAR mapping™ software on a computer device.
Pulmonary vein isolationProcedure or surgery
Catheter ablation for persistent AF consisting of pulmonary vein isolation (the standard treatment for AF)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Pulmonary vein isolation alone (by catheter ablation) Receives: Procedure: Pulmonary vein isolation |
| STAR guided ablation group | Experimental | Pulmonary vein isolation plus ablation guided by STAR MappingTM Receives: Procedure: Pulmonary vein isolation plus ablation guided by novel STAR mapping™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of subjects in the 2 groups with clinical success
Clinical success is defined as freedom from atrial arrhythmia (AF or atrial tachycardia) lasting >30 seconds after a single procedure off antiarrhythmic drugs subsequent to a 3 month blanking period (standard guideline definition of clinical success).
Measured: 12 months
Comparison of the proportion of subjects in the 2 groups with termination of AF during ablation
Termination of AF during ablation
Measured: During the index procedure (i.e. day 0)
Secondary outcomes (9)
Comparison of the proportion of subjects in the 2 groups with major complications following their index procedure.
major complications are defined as any complication causing death, disability, results in another intervention, or prolongs hospital stay (as per guidelines).
Measured: 30 days
Comparison of the proportion of subjects in the 2 groups with early failure following their index procedure.
Early failure is described as recurrent AF or atrial tachycardia at the 3 months time point.
Measured: 3 months
Comparison of the proportion of subjects in the 2 groups reaching a composite electrophysiological end point during their index procedure
The composite electrophysiological end point is comprised of either AF termination or slowing of AF cycle length ≥30ms measured from the left atrial appendage during ablation.
Measured: During the index ablation procedure (i.e. day 0)
Radiofrequency ablation time
Duration of radiofrequency ablation
Measured: Intraprocedural
Procedure time
Duration of procedure
Measured: Intraprocedural
Comparison of the proportion of subjects in the 2 groups with freedom from AF
Freedom from AF defined as no documented AF (>30 seconds) following the 3 months blanking period following a single procedure, off anti-arrhythmic drugs.
Measured: 12 months
Comparison of the proportion of subjects in the 2 groups with freedom from atrial arrhythmia allowing for antiarrhythmic drugs.
Freedom from documented atrial arrhythmia (>30 seconds) following the 3 months blanking period following a single procedure, allowing for anti-arrhythmic drugs.
Measured: 12 months
Comparison of the proportion of subjects in the 2 groups with freedom from AF allowing for antiarrhythmic drugs
Freedom from AF defined as no documented AF (>30 seconds) following the 3 months blanking period following a single procedure, allowing for anti-arrhythmic drugs.
Measured: 12 months
Relationship between the number of AF drivers identified using STAR mapping™ and clinical outcome
The number of AF drivers identified will be correlated to the proportion of patients with clinical success at 1 year (the primary end-point). This analysis will be performed for all 177 patients, and for each of the 2 groups separately.
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 posted22 Jun 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: Study cancelled. Different direction pursued by Rhythm AI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhythm AI Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442113
- Sponsor's protocol ID
- ROC-STAR
- Acronym
- ROC-STAR
- Status last verified
- Apr 2021
- First submitted
- 18 Jun 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Honarbakhsh S, Hunter RJ, Finlay M, Ullah W, Keating E, Tinker A, Schilling RJ. Development, in vitro validation and human application of a novel method to identify arrhythmia mechanisms: The stochastic trajectory analysis of ranked signals mapping method. J Cardiovasc Electrophysiol. 2019 May;30(5):691-701. doi: 10.1111/jce.13882. Epub 2019 Mar 5.
PubMed 30801836Honarbakhsh S, Hunter RJ, Ullah W, Keating E, Finlay M, Schilling RJ. Ablation in Persistent Atrial Fibrillation Using Stochastic Trajectory Analysis of Ranked Signals (STAR) Mapping Method. JACC Clin Electrophysiol. 2019 Jul;5(7):817-829. doi: 10.1016/j.jacep.2019.04.007. Epub 2019 May 8.
PubMed 31320010Honarbakhsh S, Schilling RJ, Finlay M, Keating E, Ullah W, Hunter RJ. STAR mapping method to identify driving sites in persistent atrial fibrillation: Application through sequential mapping. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2694-2703. doi: 10.1111/jce.14201. Epub 2019 Oct 3.
PubMed 31552697Honarbakhsh S, Schilling RJ, Keating E, Finlay M, Hunter RJ. Drivers in AF colocate to sites of electrogram organization and rapidity: Potential synergy between spectral analysis and STAR mapping approaches in prioritizing drivers for ablation. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1340-1349. doi: 10.1111/jce.14456. Epub 2020 Apr 9.
PubMed 32219906
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Assessing Targeted Ablation in Persistent Atrial Fibrillation Using the Stochastic Trajectory Analysis of Ranked Signals (STAR Mapping™) Method.
- ClinicalTrials.gov ID
- NCT04442113
- Acronym / sponsor ID
- ROC-STAR / ROC-STAR
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Catheter ablation, Arrhythmia, Cardiac mapping
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled. Different direction pursued by Rhythm AI.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rhythm AI LtdIndustry (pharma, biotech, devices)
- Collaborators
- Biosense Webster, Inc.
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 22 Jun 2020 (actual)
- 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.
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity. Catheter ablation is a safe treatment which is effective for paroxysmal AF but the success rate for persistent AF remains approximately 50% at 1 year. A new mapping technique, called Stochastic Trajectory Analysis of Ranked signals (STAR Mapping™) Method, has recently been developed. In a pilot study, localised sources driving AF were consistently mapped and ablated with excellent acute and long term outcomes. This trial will test the clinical effectiveness of this approach by comparing conventional ablation with pulmonary vein isolation (PVI) to PVI plus STAR mapping™ guided ablation. We plan to test this through a prospective multicenter randomized controlled trial including 177 patients.
Detailed description
This will be a prospective multi-centre randomised controlled trial with two treatment arms. We plan to include up to 15 UK centres. Patients that have been referred for catheter ablation of symptomatic persistent AF will be recruited. Patients will be consented and have their baseline review after having been listed for AF ablation on the hospital waiting list. They will be randomized to one of two treatment arms. All patients will undergo their procedure using a 3D mapping system. Standard catheters will be used during the ablation procedure. Because the STAR mapping™ system will be configured for use with a special version of the 3D mapping system Carto (BIosense Webster) the study will mandate use of clinically approved Carto catheters: Smarttouch thermocool ablation catheter and the Pentarray mapping catheter. Ablation procedures will be carried out using the usual policies and protocols of the institutions involved except for the specific points below. The two treatment arms include:
- Control arm - PVI alone After PVI, no further ablation in AF will be allowed. If the patient organizes into an atrial tachycardia (AT) during PVI this will be mapped and ablated. Otherwise, in accordance with common clinical practice, a 30 minute waiting period will be observed following PVI to watch for acute pulmonary vein reconnection. During this waiting period, mapping data will be acquired using the multipolar pulmonary vein mapping catheter to acquire STAR mapping™ data. The operator will be blinded to these data. This is done using the pentarray mapping catheter to acquire a minimum of 10 widely spaced globally distributed left atrial recordings of 30 seconds each outside the pulmonary veins. If the patient has remained in AF post PVI then electrical cardioversion will be performed, the pulmonary veins checked and re-isolated if needed, and the procedure terminated.
- Experimental arm - PVI followed by STAR guided ablation. If the patient organises to sinus rhythm after PVI alone then a 30 minute wait will be observed to ensure sustained PVI and the procedure terminated. If patients remain in AF following PVI, the left atrium will be mapped using a multipolar mapping catheter to acquire a minimum of 10 widely spaced globally distributed recordings outside the pulmonary veins. STAR mapping™ data will be exported and maps generated. Ablation will then be targeted at the leading sites identified by STAR mapping™ in order of ranking (1st first, 2nd second, etc.) with the end-point of AF termination. If AF terminates further sites will not be targeted. If patients terminate to an atrial tachycardia then this will be mapped and ablated as per standard clinical practice.
If AF persists following ablation of all STAR mapping™ identified sites then mapping of the right atrium may be considered if the septum consistently activates early and the coronary sinus activation is predominantly proximal to distal, and further ablation permitted in the right atrium if indicated. If patients remain in AF following ablation then they will be electrically cardioverted.
Follow-up All patients will undergo 12 months follow-up with an ECG at 3, 6, 9 and 12 months, and a 48h ambulatory Holter monitor at 6 and 12 months. Patients will routinely continue anti-arrhythmic therapy for up to 3 months post procedure which will be considered a blanking period. After 3 months rhythmically active antiarrhythmic drugs will be stopped.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Pulmonary vein isolationPulmonary vein isolation alone (by catheter ablation) |
| STAR guided ablation group | Experimental | Procedure: Pulmonary vein isolation plus ablation guided by novel STAR mapping™Pulmonary vein isolation plus ablation guided by STAR MappingTM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persistent AF (continuous AF duration between 1 week and 24 months)
- No previous AF ablation or other left atrial ablation
- Undergoing a clinical AF ablation procedure.
Key exclusion criteria (17 listed)
- Unwillingness to sign consent
- Any other contraindication to catheter ablation
- Age <18 years or > 80 years
- AF with a reversible cause
- AF that is paroxysmal
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 |
|---|---|---|
| Pulmonary vein isolation plus ablation guided by novel STAR mapping™Catheter ablation for persistent AF consisting of pulmonary vein isolation plus additional ablation guided by the novel STAR mapping™ software on a computer device. | Procedure or surgery | STAR guided ablation group |
| Pulmonary vein isolationCatheter ablation for persistent AF consisting of pulmonary vein isolation (the standard treatment for AF) | Procedure or surgery | Control group |
Primary outcome
Comparison of the proportion of subjects in the 2 groups with clinical success
Time frame: 12 months
Clinical success is defined as freedom from atrial arrhythmia (AF or atrial tachycardia) lasting >30 seconds after a single procedure off antiarrhythmic drugs subsequent to a 3 month blanking period (standard guideline definition of clinical success).
Comparison of the proportion of subjects in the 2 groups with termination of AF during ablation
Time frame: During the index procedure (i.e. day 0)
Termination of AF during ablation
9 secondary outcomes
Comparison of the proportion of subjects in the 2 groups with major complications following their index procedure.
Time frame: 30 days
Comparison of the proportion of subjects in the 2 groups with early failure following their index procedure.
Time frame: 3 months
Comparison of the proportion of subjects in the 2 groups reaching a composite electrophysiological end point during their index procedure
Time frame: During the index ablation procedure (i.e. day 0)
Radiofrequency ablation time
Time frame: Intraprocedural
Procedure time
Time frame: Intraprocedural
Comparison of the proportion of subjects in the 2 groups with freedom from AF
Time frame: 12 months
Comparison of the proportion of subjects in the 2 groups with freedom from atrial arrhythmia allowing for antiarrhythmic drugs.
Time frame: 12 months
Comparison of the proportion of subjects in the 2 groups with freedom from AF allowing for antiarrhythmic drugs
Time frame: 12 months
Relationship between the number of AF drivers identified using STAR mapping™ and clinical outcome
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Background: PubMed 30801836Honarbakhsh S, Hunter RJ, Finlay M, Ullah W, Keating E, Tinker A, Schilling RJ. Development, in vitro validation and human application of a novel method to identify arrhythmia mechanisms: The stochastic trajectory analysis of ranked signals mapping method. J Cardiovasc Electrophysiol. 2019 May;30(5):691-701. doi: 10.1111/jce.13882. Epub 2019 Mar 5.
- Background: PubMed 31320010Honarbakhsh S, Hunter RJ, Ullah W, Keating E, Finlay M, Schilling RJ. Ablation in Persistent Atrial Fibrillation Using Stochastic Trajectory Analysis of Ranked Signals (STAR) Mapping Method. JACC Clin Electrophysiol. 2019 Jul;5(7):817-829. doi: 10.1016/j.jacep.2019.04.007. Epub 2019 May 8.
- Background: PubMed 31552697Honarbakhsh S, Schilling RJ, Finlay M, Keating E, Ullah W, Hunter RJ. STAR mapping method to identify driving sites in persistent atrial fibrillation: Application through sequential mapping. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2694-2703. doi: 10.1111/jce.14201. Epub 2019 Oct 3.
- Background: PubMed 32219906Honarbakhsh S, Schilling RJ, Keating E, Finlay M, Hunter RJ. Drivers in AF colocate to sites of electrogram organization and rapidity: Potential synergy between spectral analysis and STAR mapping approaches in prioritizing drivers for ablation. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1340-1349. doi: 10.1111/jce.14456. Epub 2020 Apr 9.
- Rhythm AI Ltd websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation plus ablation guided by novel STAR mapping™ and Pulmonary vein isolation in people with Atrial Fibrillation, run by Rhythm AI Ltd.
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 17 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: withdrawn, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Comparison of the proportion of subjects in the 2 groups with clinical success (time frame: 12 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 NCT04442113, which also lists 4 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 14 Apr 2021.