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

March 9, 2023 updated by: Jose Luis Ibañez Criado
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • A
      • Alicante, A, Spain, 03010
        • Recruiting
        • Hospital General Doctor Balmis Alicante
        • Contact:
        • Contact:
        • Sub-Investigator:
          • 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
        • Principal Investigator:
          • Jose Luis Ibáñez Criado, MD, PhD
        • Sub-Investigator:
          • Raquel Ajo Ferrer, PhD
        • Sub-Investigator:
          • María Ajo Ferrer
        • Sub-Investigator:
          • Ángela Carrillo Molina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: 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.
Procedure: High-power short-duration ablation
Point-by-point 90W applications at the CTI ablation during 4 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety primary outcome: incidence of procedure-related complications.
Time Frame: One year
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.
Time Frame: 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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose Luis Ibañez Criado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASD-HP trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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