Atrial FlutterAITAFNCT06406686
Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)
A study testing Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter in people with Atrial Flutter and Atrial Flutter Typical, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter, Atrial Flutter Typical, Cavotricuspid Isthmus Dependent Macroreentry Tachycardia
- What is being tested?
- Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jun 2024to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically determined by a cardiac electrophysiologist to have had at least one episode of CTI dependent atrial flutter
- Clinically determined by a cardiac electrophysiologist likely to benefit from standalone CTI ablation
- For this to be their first CTI ablation attempt
- Able and willing to comply with all protocol requirements
- Agree to and sign patient Informed Consent Form (ICF)
- Be 18 years of age or older
Who cannot join
- Previous CTI ablation
- Adult congenital heart disease, including Ebstein's anomaly
- Previous surgery involving the tricuspid valve and atrium including cannulation scars for cardiopulmonary bypass
- Pediatric population age <18
- Women who are pregnant or breastfeeding.
- Active enrollment in another investigational study involving a drug or device.
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- A requirement for additional procedures in the same setting. Such as EP study and ablation of other induced arrhythmias since these prolong secondary endpoints such as procedure time and RF time
- Patients on anti-arrhythmic drugs (AADs) such as flecainide, sotalol, or amiodarone should have their AAD stopped 3 days prior, and not be restarted after the procedure
- Patients under General Anesthetic (GA)
- Patients with sufficient baseline cognitive impairment to be unable to answer a post-procedure survey or consent Previous ablations, other than for CTI flutter, are acceptable.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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, 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.
- Conditions
- Atrial Flutter, Atrial Flutter Typical, Cavotricuspid Isthmus Dependent Macroreentry Tachycardia
- Being tested
- Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter
- Keywords
- Ablation, High power short duration, CARTO, QDot Micro, Ablation Index
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation of the Cavo-tricuspid isthmus for typical Atrial FlutterProcedure or surgery
Durable block across the cavotricuspid isthmus by radiofrequency ablation.
| Study group | Role | What they receive |
|---|---|---|
| 30 Watt | Active comparator | Power set to 30 Watts Receives: Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter |
| 50 Watt | Experimental | Power set to 50 Watts Receives: Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter |
What is being measured
The primary outcome is the main question the study is designed to answer.
RF time to durable CTI block
Cumulative delivery time of radio-frequency lesions
Measured: End of procedure
Secondary outcomes (9)
RF time to initial CTI block
At the point of initial CTI block, the total cumulative time applying radiofrequency energy
Measured: End of procedure
Total procedure time
Time from procedure start to procedure end
Measured: 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
Measured: 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
Measured: End of procedure
Total analgesia and sedation usage
Cumulative doses of sedation and analgesic medicines
Measured: 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.
Measured: End of procedure day
Steam pops
Count of audible "steam-pops" during the procedure
Measured: End of procedure
Pericardial effusions
Observation of new effusion after the procedure
Measured: End of procedure day
Pericardial tamponade
Observation of hemodynamically significant pericardial effusion periprocedurally warranting intervention
Measured: End of procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start3 Jun 2024 (estimated)
- Primary completion3 Jun 2025 (estimated)
- Study completion3 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rory Dowd, University of Calgary
- Investigators
- George D Veenhuyzen, MD, Principal investigator, University of CalgaryRory P Dowd, MBBS, MEng, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406686
- Sponsor's protocol ID
- REB24-0132
- Acronym
- AITAF
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Golian M, Ramirez FD, Alqarawi W, Hansom SP, Nery PB, Redpath CJ, Nair GM, Shaw GC, Davis DR, Birnie DH, Sadek MM. High-power short-duration radiofrequency ablation of typical atrial flutter. Heart Rhythm O2. 2020 Oct 3;1(5):317-323. doi: 10.1016/j.hroo.2020.09.002. eCollection 2020 Dec.
PubMed 34113888
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)
- ClinicalTrials.gov ID
- NCT06406686
- Acronym / sponsor ID
- AITAF / REB24-0132
- Conditions
- Atrial Flutter, Atrial Flutter Typical, Cavotricuspid Isthmus Dependent Macroreentry Tachycardia
- Keywords
- Ablation, High power short duration, CARTO, QDot Micro, Ablation Index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 3 Jun 2024 (estimated)
- Primary completion
- 3 Jun 2025 (estimated)
- Study completion
- 3 Jun 2025 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 Watt | Active comparator | Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial FlutterPower set to 30 Watts |
| 50 Watt | Experimental | Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial FlutterPower set to 50 Watts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically determined by a cardiac electrophysiologist to have had at least one episode of CTI dependent atrial flutter
- Clinically determined by a cardiac electrophysiologist likely to benefit from standalone CTI ablation
- For this to be their first CTI ablation attempt
- Able and willing to comply with all protocol requirements
- Agree to and sign patient Informed Consent Form (ICF)
Key exclusion criteria (10 listed)
- Previous CTI ablation
- Adult congenital heart disease, including Ebstein's anomaly
- Previous surgery involving the tricuspid valve and atrium including cannulation scars for cardiopulmonary bypass
- Pediatric population age <18
- Women who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation of the Cavo-tricuspid isthmus for typical Atrial FlutterDurable block across the cavotricuspid isthmus by radiofrequency ablation. | Procedure or surgery | 30 Watt, 50 Watt |
Primary outcome
RF time to durable CTI block
Time frame: End of procedure
Cumulative delivery time of radio-frequency lesions
9 secondary outcomes
RF time to initial CTI block
Time frame: End of procedure
Total procedure time
Time frame: End of procedure
Incidence of early re-connections during wait period
Time frame: End of procedure
Total number of ablation lesions required to achieve durable CTI block
Time frame: End of procedure
Total analgesia and sedation usage
Time frame: End of procedure
Post-procedure patient perception of pain and nausea
Time frame: End of procedure day
Steam pops
Time frame: End of procedure
Pericardial effusions
Time frame: End of procedure day
Pericardial tamponade
Time frame: End of procedure day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 34113888Golian M, Ramirez FD, Alqarawi W, Hansom SP, Nery PB, Redpath CJ, Nair GM, Shaw GC, Davis DR, Birnie DH, Sadek MM. High-power short-duration radiofrequency ablation of typical atrial flutter. Heart Rhythm O2. 2020 Oct 3;1(5):317-323. doi: 10.1016/j.hroo.2020.09.002. eCollection 2020 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George D Veenhuyzen, MD principal investigator
University of Calgary
Rory P Dowd, MBBS, MEng principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter in people with Atrial Flutter and Atrial Flutter Typical, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George D Veenhuyzen, MD ((403) 944-3385, George.Veenhuyzen@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RF time to durable CTI block (time frame: End of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06406686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.