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

NCT05777850 | Unknown DMC

• 1 other identifier: FASD-HP trial
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Typical Atrial Flutter; Catheter Ablation

Keywords

Typical Atrial Flutter Cavotricuspid Isthmus; Cavotricuspid Isthmus; High-Power Short-Duration

Outcome Measures

Primary Outcomes (2)

• Safety primary outcome: incidence of procedure-related complications.

  Number of procedure-related complications from the time of the ablation until the last follow-up visit.

  One year

• Efficacy primary outcome: typical atrial flutter recurrence.

  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.

  One year

Study Arms (2)

Conventional ablation

ACTIVE COMPARATOR

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.

Procedure: Conventional cavotricuspid isthmus ablation

High-power short-duration ablation

EXPERIMENTAL

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.

Procedure: High-power short-duration ablation

Interventions

Conventional cavotricuspid isthmus ablation PROCEDURE

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

Conventional ablation

High-power short-duration ablation PROCEDURE

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

High-power short-duration ablation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jose Luis Ibañez Criado: lead

Study Sites (1)

Hospital General Doctor Balmis Alicante

Alicante, A, 03010, Spain

RECRUITING

Related Publications (1)

• Valverde Soria L, Toquero J, Brouzet T, Garcia Cano L, Garcia Barrios A, Segura Dominguez M, Hermon Ramirez GA, Ajo Ferrer R, Ajo Ferrer M, Andreu Concha CM, Arrarte Esteban V, Sanchez Barbie A, Martinez-Martinez JG, Ibanez Criado A, Ibanez Criado JL. Very high-power short-duration radiofrequency ablation in patients with typical atrial flutter: rationale and design of the FASD-HP randomized trial. J Interv Card Electrophysiol. 2025 Apr;68(3):497-503. doi: 10.1007/s10840-024-01969-7. Epub 2024 Dec 21.

  PMID: 39708245 DERIVED

Central Study Contacts

Laura Valverde Soria

CONTACT

687198597; lauravalverdesoria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 21, 2023
• Study Start: October 25, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

ES (1)