Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406686
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Ablation Index in Standard vs High Power Radiofrequency Ablation for Typical Atrial Flutter A Randomized Study AITAF
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Ablation Index in Standard vs High Power Radiofrequency Ablation for Typical Atrial Flutter A Randomized Study AITAF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AITAF
Brief Summary:
A randomized controlled trial will be conducted to evaluate the efficacy of Ablation Index-guided high power - short duration HPSD ablation compared to conventional power settings in Cavotricuspid Isthmus CTI dependent atrial flutter Participants will be randomized to receive either AI-guided HPSD ablation at 50 Watts or conventional power settings at 30 Watts Both arms will use the Carto 3D mapping system and the QDOT MICRO ablation catheter Biosense Webster An anatomically contiguous line will be created with 6mm inter-lesion distance After a standardized wait time of 30 minutes ablation success will be assessed The primary outcome is total radiofrequency ablation time Secondary outcomes include procedural time fluoroscopy time safety outcomes and 3-month freedom from recurrence It is our expectation that HPSD will result in a shorter primary outcome
Detailed Description:
Title A Randomized Trial of Ablation Index Guided High vs Standard Power Radiofrequency Ablation for Typical Atrial Flutter
Design Prospective two-arm single center superiority study with comparison of standard 30W power settings vs 50W high power settings
Purpose To evaluate the superiority of high-power ablation settings over standard power settings in achieving block across the CTI for typical flutter
Enrollment A minimum of 25 subjects in each arm Enrollment over a period of 12 months
Subjects Subjects referred by a cardiac electrophysiologist for standalone radiofrequency ablation of typical atrial flutter
Clinical site Foothills Medical Center University of Calgary Calgary Alberta Canada
Endpoints Primary endpoint total radiofrequency time per procedure
Secondary endpoints
RF time to initial CTI block Total procedure time Time from procedure start to procedure end Incidence of early reconnections during wait period Incidence of dormant conduction during adenosine testing Total number of ablation lesions required to achieve durable CTI block Total analgesia and sedation usage eg midazolam fentanyl and propofol in mg andor mL Post-procedure patient perception of a pain and b nausea on a scale of 1 none to 10 maximum possible
Secondary safety endpoints
Steam pops Pericardial effusions Pericardial tamponade
Secondary follow-up outcomes
The presence of durable CTI block if a subsequent EP study is performed within 3 months of the initial procedure eg AF ablation Recurrence of documented AFL within 3 months by available ECGs telemetry wearable monitors or Holters Holter at 2 months for incidence and burden of atrial arrhythmias
Materials 3-D electro-anatomical mapping system CARTO Biosense Webster Diagnostic catheters 20-pole halo catheter 10 pole coronary sinus catheter Ablation catheter QDOT MICRO BiosenseWebster
Sponsors None fellow initiated research
Despite the existing observational data there have been no randomized controlled trials RCTs investigating HPSD in CTI ablation to validate its effectiveness Furthermore the applicability of AI to CTI ablation has not been tested Its important to note that CTI ablation performed under conscious sedation introduces respiratory movement leading to increased CF variability which may affect precise energy delivery
We propose conducting the first RCT to our knowledge investigating the use of High-Power Short-Duration Ablation HPSD in the treatment of CTI-dependent flutter
Design Prospective two-arm single center superiority study with comparison of standard 30W power settings vs 50W high power settings
Purpose To evaluate the superiority of high-power ablation settings over standard power settings in achieving block across the CTI for typical flutter
Enrollment A minimum of 25 subjects in each arm Enrollment over a period of 12 months
Subjects Subjects referred by a cardiac electrophysiologist for standalone radiofrequency ablation of typical atrial flutter
Clinical site Foothills Medical Center University of Calgary Calgary Alberta Canada
Endpoints Primary endpoint total radiofrequency time per procedure
Secondary endpoints
RF time to initial CTI block Total procedure time Time from procedure start to procedure end Incidence of early reconnections during wait period Incidence of dormant conduction during adenosine testing Total number of ablation lesions required to achieve durable CTI block Total analgesia and sedation usage eg midazolam fentanyl and propofol in mg andor mL Post-procedure patient perception of a pain and b nausea on a scale of 1 none to 10 maximum possible
Secondary safety endpoints
Steam pops Pericardial effusions Pericardial tamponade
Secondary follow-up outcomes
The presence of durable CTI block if a subsequent EP study is performed within 3 months of the initial procedure eg AF ablation Recurrence of documented AFL within 3 months by available ECGs telemetry wearable monitors or Holters Holter at 2 months for incidence and burden of atrial arrhythmias
Materials 3-D electro-anatomical mapping system CARTO Biosense Webster Diagnostic catheters 20-pole halo catheter 10 pole coronary sinus catheter Ablation catheter QDOT MICRO BiosenseWebster
Sponsors None fellow initiated research
Despite the existing observational data there have been no randomized controlled trials RCTs investigating HPSD in CTI ablation to validate its effectiveness Furthermore the applicability of AI to CTI ablation has not been tested Its important to note that CTI ablation performed under conscious sedation introduces respiratory movement leading to increased CF variability which may affect precise energy delivery
We propose conducting the first RCT to our knowledge investigating the use of High-Power Short-Duration Ablation HPSD in the treatment of CTI-dependent flutter
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