Atrial Fibrillation Clinical Trial
— ROC-STAROfficial title:
Multicenter Randomized Controlled Trial Assessing Targeted Ablation in Persistent Atrial Fibrillation Using the Stochastic Trajectory Analysis of Ranked Signals (STAR Mapping™) Method.
Verified date | April 2021 |
Source | Rhythm AI Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Rhythm AI Ltd | Biosense Webster, Inc. |
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. — View Citation
Honarbakhsh 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. — View Citation
Honarbakhsh 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. — View Citation
Honarbakhsh 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 12 months | |
Primary | Comparison of the proportion of subjects in the 2 groups with termination of AF during ablation | Termination of AF during ablation | During the index procedure (i.e. day 0) | |
Secondary | 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). | 30 days | |
Secondary | 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. | 3 months | |
Secondary | 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. | During the index ablation procedure (i.e. day 0) | |
Secondary | Radiofrequency ablation time | Duration of radiofrequency ablation | Intraprocedural | |
Secondary | Procedure time | Duration of procedure | Intraprocedural | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months |
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