Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)

NCT06406686 | Not Yet Recruiting

• 1 other identifier: REB24-0132
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Flutter; Atrial Flutter Typical; Cavotricuspid Isthmus Dependent Macroreentry Tachycardia

Keywords

Ablation; High power short duration; CARTO; QDot Micro; Ablation Index

Outcome Measures

Primary Outcomes (1)

• RF time to durable CTI block

  Cumulative delivery time of radio-frequency lesions

  End of procedure

Secondary Outcomes (9)

• RF time to initial CTI block

  End of procedure

• Total procedure time

  End of procedure

• Incidence of early re-connections during wait period

  End of procedure

• Total number of ablation lesions required to achieve durable CTI block

  End of procedure

• Total analgesia and sedation usage

  End of procedure

Study Arms (2)

30 Watt

ACTIVE COMPARATOR

Power set to 30 Watts

Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter

50 Watt

EXPERIMENTAL

Power set to 50 Watts

Procedure: Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter

Interventions

Ablation of the Cavo-tricuspid isthmus for typical Atrial Flutter PROCEDURE

Durable block across the cavotricuspid isthmus by radiofrequency ablation.

30 Watt; 50 Watt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (1)

• 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.

  PMID: 34113888 BACKGROUND

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George D Veenhuyzen, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Rory P Dowd, MBBS, MEng

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George D Veenhuyzen, MD

CONTACT

(403) 944-3385; George.Veenhuyzen@albertahealthservices.ca

Stephen Wilton, MD

CONTACT

(403) 210-7102; sbwilton@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single-blinded. Investigator will know study arm, patients/participants will not. The outcomes assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EP fellow

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: June 3, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)