An interventional study of Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter in Atrial Flutter, Atrial Flutter Typical and Cavotricuspid Isthmus Dependent Macroreentry Tachycardia, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
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.
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, e.g. midazolam, fentanyl and propofol in mg and/or 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 (e.g. 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. It's 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.
223 studies on the registry are indexed under Atrial Flutter; 51 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 155 interventional studies indexed under Atrial Flutter.
Browse Atrial Flutter studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Power set to 30 Watts
Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter
Power set to 50 Watts
Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter
Durable block across the cavotricuspid isthmus by radiofrequency ablation.
RF time to durable CTI block
Cumulative delivery time of radio-frequency lesions
Time frame: End of procedure
RF time to initial CTI block
At the point of initial CTI block, the total cumulative time applying radiofrequency energy
Time frame: End of procedure
Total procedure time
Time from procedure start to procedure end
Time frame: End of procedure
Incidence of early re-connections during wait period
Whether or not conduction was observed across the CTI before the wait period had expired
Time frame: End of procedure
Total number of ablation lesions required to achieve durable CTI block
At the point of durable CTI block, the total cumulative number of radiofrequency lesions deployed
Time frame: End of procedure
Total analgesia and sedation usage
Cumulative doses of sedation and analgesic medicines
Time frame: End of procedure
Post-procedure patient perception of pain and nausea
Post-procedure patient perception of a) pain and b) nausea on a scale of 1 (none) to 10 (maximum possible) assessed after the procedure and prior to discharge.
Time frame: End of procedure day
Steam pops
Count of audible "steam-pops" during the procedure
Time frame: End of procedure
Pericardial effusions
Observation of new effusion after the procedure
Time frame: End of procedure day
Pericardial tamponade
Observation of hemodynamically significant pericardial effusion periprocedurally warranting intervention
Time frame: End of procedure day
Plan to share: No
Start is estimated for Jun 2024; primary completion for Jun 2025, 12 months later.
Of 55 interventional studies with no phase under Atrial Flutter, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's planned 12 months is below that.
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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