RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF. (ROC-STAR)
Primary Purpose
Atrial Fibrillation
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary vein isolation plus ablation guided by novel STAR mapping™
Pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Catheter ablation, Arrhythmia, Cardiac mapping
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
STAR guided ablation group
Arm Description
Pulmonary vein isolation alone (by catheter ablation)
Pulmonary vein isolation plus ablation guided by STAR MappingTM
Outcomes
Primary Outcome Measures
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).
Comparison of the proportion of subjects in the 2 groups with termination of AF during ablation
Termination of AF during ablation
Secondary Outcome Measures
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).
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.
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.
Radiofrequency ablation time
Duration of radiofrequency ablation
Procedure time
Duration of procedure
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.
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.
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.
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.
Full Information
NCT ID
NCT04442113
First Posted
June 18, 2020
Last Updated
April 9, 2021
Sponsor
Rhythm AI Ltd
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04442113
Brief Title
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
Acronym
ROC-STAR
Official Title
Multicenter Randomized Controlled Trial Assessing Targeted Ablation in Persistent Atrial Fibrillation Using the Stochastic Trajectory Analysis of Ranked Signals (STAR Mapping™) Method.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study cancelled. Different direction pursued by Rhythm AI.
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhythm AI Ltd
Collaborators
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Catheter ablation, Arrhythmia, Cardiac mapping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation alone (by catheter ablation)
Arm Title
STAR guided ablation group
Arm Type
Experimental
Arm Description
Pulmonary vein isolation plus ablation guided by STAR MappingTM
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation plus ablation guided by novel STAR mapping™
Intervention Description
Catheter ablation for persistent AF consisting of pulmonary vein isolation plus additional ablation guided by the novel STAR mapping™ software on a computer device.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation
Intervention Description
Catheter ablation for persistent AF consisting of pulmonary vein isolation (the standard treatment for AF)
Primary Outcome Measure Information:
Title
Comparison of the proportion of subjects in the 2 groups with clinical success
Description
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).
Time Frame
12 months
Title
Comparison of the proportion of subjects in the 2 groups with termination of AF during ablation
Description
Termination of AF during ablation
Time Frame
During the index procedure (i.e. day 0)
Secondary Outcome Measure Information:
Title
Comparison of the proportion of subjects in the 2 groups with major complications following their index procedure.
Description
major complications are defined as any complication causing death, disability, results in another intervention, or prolongs hospital stay (as per guidelines).
Time Frame
30 days
Title
Comparison of the proportion of subjects in the 2 groups with early failure following their index procedure.
Description
Early failure is described as recurrent AF or atrial tachycardia at the 3 months time point.
Time Frame
3 months
Title
Comparison of the proportion of subjects in the 2 groups reaching a composite electrophysiological end point during their index procedure
Description
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.
Time Frame
During the index ablation procedure (i.e. day 0)
Title
Radiofrequency ablation time
Description
Duration of radiofrequency ablation
Time Frame
Intraprocedural
Title
Procedure time
Description
Duration of procedure
Time Frame
Intraprocedural
Title
Comparison of the proportion of subjects in the 2 groups with freedom from AF
Description
Freedom from AF defined as no documented AF (>30 seconds) following the 3 months blanking period following a single procedure, off anti-arrhythmic drugs.
Time Frame
12 months
Title
Comparison of the proportion of subjects in the 2 groups with freedom from atrial arrhythmia allowing for antiarrhythmic drugs.
Description
Freedom from documented atrial arrhythmia (>30 seconds) following the 3 months blanking period following a single procedure, allowing for anti-arrhythmic drugs.
Time Frame
12 months
Title
Comparison of the proportion of subjects in the 2 groups with freedom from AF allowing for antiarrhythmic drugs
Description
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.
Time Frame
12 months
Title
Relationship between the number of AF drivers identified using STAR mapping™ and clinical outcome
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30801836
Citation
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.
Results Reference
background
PubMed Identifier
31320010
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.
Results Reference
background
PubMed Identifier
31552697
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.
Results Reference
background
PubMed Identifier
32219906
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.
Results Reference
background
Links:
URL
https://rhythm-ai.com/
Description
Rhythm AI Ltd website
Learn more about this trial
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
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