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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Typical Atrial Flutter Catheter Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Conventional 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.

Group Type ACTIVE_COMPARATOR

Conventional cavotricuspid isthmus ablation

Intervention Type PROCEDURE

Point-by-point 25-40 W applications at the CTI of unlimited duration until achieving the pre-established Ablation Index.

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.

Group Type EXPERIMENTAL

High-power short-duration ablation

Intervention Type PROCEDURE

Point-by-point 90W applications at the CTI ablation during 4 seconds.

Interventions

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Conventional cavotricuspid isthmus ablation

Point-by-point 25-40 W applications at the CTI of unlimited duration until achieving the pre-established Ablation Index.

Intervention Type PROCEDURE

High-power short-duration ablation

Point-by-point 90W applications at the CTI ablation during 4 seconds.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No