High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter

Not Applicable

Recruiting

• Conditions: Typical Atrial Flutter; Catheter Ablation
• Interventions: Procedure: Conventional cavotricuspid isthmus ablation; Procedure: High-power short-duration ablation

• Registration Number: NCT05777850
• Lead Sponsor: Jose Luis Ibañez Criado

Brief Summary

The aim of cavotricuspid isthmus (CTI) dependent flutter ablation is the bidirectional conduction block of CTI. The probability of achieving a permanent bidirectional block at the CTI depends, mainly, on the ablation energy applied and the quality of the obtained lesion. Among the factors that determine the lesion's quality those which have the bigger impact are catheter stability, contact force, power and duration of energy application and the temperature reached at depth.This is a multicenter 1:1 randomized, blinded (open for the operator) study. Two CTI ablation strategies are compared: 1) conventional treatment branch which consists of individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers (Ablation Index \>500 at the anterior half of the CTI and \>400 at the posterior half with de CARTO 3 system; 2) experimental treatment branch consistent of CTI block using individual high power (90W) short duration (4 seconds) point-by-point applications. The main objective of this study is assessing the non-inferiority of the efficacy and safety of high-power short-duration ablation in patients undergoing typical atrial flutter ablation. Secondary objectives include the comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure and time to atrial flutter recurrence.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Status Verified: 2023-03
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2024-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with cavotricuspid isthmus dependent flutter referred to ablation
• Patients clinically and hemodynamically stable.
• Patients who give informed consent.

Exclusion Criteria

• Refusal to participate in the register or inability to understand the informed consent.
• Age under 18.
• Patients who have already undergone previous flutter ablation procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ablation	Conventional cavotricuspid isthmus ablation	CTI ablation with electroanatomic navigation system using individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers: Ablation Index \>500 at the anterior half of the CTI and \>400 at the posterior half with de CARTO 3 system. Minimum contact force required is 5 grams. Maximum distance between applications must be 6 mm.
High-power short-duration ablation	High-power short-duration ablation	CTI ablation with electroanatomic navigation system using individual high power (90W) short duration (4 seconds) applications in a catheters' stable position with a minimum contact force of 15-30 g at the anterior half and 10-25 g at the posterior one. Maximum distance between applications is settled at 4 mm.

Primary Outcome Measures

Name	Time	Method
Safety primary outcome: incidence of procedure-related complications.	One year	Number of procedure-related complications from the time of the ablation until the last follow-up visit.
Efficacy primary outcome: typical atrial flutter recurrence.	One year	Incidence of typical atrial flutter recurrence during a one-year follow-up period. To be considered clinically relevant the recurrence must be documented by a full EKG made because of patients' symptoms or any typical atrial flutter detected by an EKG, 24h Holter-EKG or events-monitoring device that will be performed at least at a 6 months and 12 months follow-up visits.

Trial Locations

Locations (1)

Hospital General Doctor Balmis Alicante; 🇪🇸 Alicante, A, Spain