High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter (FASD-HP)

Jose Luis Ibañez Criado

Status: Enrolling

Conditions: Typical Atrial Flutter; Catheter Ablation

Treatments: Procedure: High-power short-duration ablation; Procedure: Conventional cavotricuspid isthmus ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05777850

FASD-HP trial

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Conventional ablation

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional cavotricuspid isthmus ablation

High-power short-duration ablation

Experimental group

Description:

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.

Treatment:

Procedure: High-power short-duration ablation