MedPath

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

Not Applicable
Recruiting
Conditions
Typical Atrial Flutter
Catheter 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

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
Primary Outcome Measures
NameTimeMethod
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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hospital General Doctor Balmis Alicante

🇪🇸

Alicante, A, Spain

Hospital General Doctor Balmis Alicante
🇪🇸Alicante, A, Spain
Laura Valverde Soria
Contact
+34687198597
lauravalverdesoria@gmail.com
Laura Valverde Soria, MD
Sub Investigator
Alicia Ibáñez Criado, MD
Sub Investigator
Thomas Brouzet, MD
Sub Investigator
Amaya García Fernández, MD, PhD
Sub Investigator
Laura García Cano, MD
Sub Investigator
Marta Herrero Brocal, MD
Sub Investigator
Ana García Barrios, MD
Sub Investigator
Jose Luis Ibáñez Criado, MD, PhD
Principal Investigator
Raquel Ajo Ferrer, PhD
Sub Investigator
María Ajo Ferrer
Sub Investigator
Ángela Carrillo Molina
Sub Investigator

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.