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

Catheter Ablation Clinical Trial

— FASD-HP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777850
• Other study ID #: FASD-HP trial
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: Hospital General Universitario de Alicante
• Contact: Laura Valverde Soria
• Phone: 687198597
• Email: lauravalverdesoria[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Flutter
• Catheter Ablation
• Typical Atrial Flutter

Intervention

Procedure:
• Conventional cavotricuspid isthmus ablation
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
Point-by-point 90W applications at the CTI ablation during 4 seconds.

Locations

Country	Name	City	State
Spain	Hospital General Doctor Balmis Alicante	Alicante	A

Sponsors (1)

Lead Sponsor	Collaborator
Jose Luis Ibañez Criado

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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