Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442113
Status:
WITHDRAWN
Last Update Posted:
2021-04-14
First Post:
2020-06-18
Brief Title:
RandOmised Controlled Trial of STAR Mapping Guided Ablation for AF
Sponsor:
Rhythm AI Ltd
Organization:
Rhythm AI Ltd
Study Overview
Official Title:
Multicenter Randomized Controlled Trial Assessing Targeted Ablation in Persistent Atrial Fibrillation Using the Stochastic Trajectory Analysis of Ranked Signals STAR Mapping Method
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study cancelled Different direction pursued by Rhythm AI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROC-STAR
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
1 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
2 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
1 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
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None