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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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