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

Primary Purpose

Typical Atrial Flutter, Catheter Ablation

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional cavotricuspid isthmus ablation
High-power short-duration ablation
Sponsored by
Jose Luis Ibañez Criado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Typical Atrial Flutter focused on measuring Typical Atrial Flutter Cavotricuspid Isthmus, Cavotricuspid Isthmus, High-Power Short-Duration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital General Doctor Balmis AlicanteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional ablation

High-power short-duration ablation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Jose Luis Ibañez Criado
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1. Study Identification

Unique Protocol Identification Number
NCT05777850
Brief Title
High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
Acronym
FASD-HP
Official Title
High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Luis Ibañez Criado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Atrial Flutter, Catheter Ablation
Keywords
Typical Atrial Flutter Cavotricuspid Isthmus, Cavotricuspid Isthmus, High-Power Short-Duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional ablation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-power short-duration ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional cavotricuspid isthmus ablation
Intervention Description
Point-by-point 25-40 W applications at the CTI of unlimited duration until achieving the pre-established Ablation Index.
Intervention Type
Procedure
Intervention Name(s)
High-power short-duration ablation
Intervention Description
Point-by-point 90W applications at the CTI ablation during 4 seconds.
Primary Outcome Measure Information:
Title
Safety primary outcome: incidence of procedure-related complications.
Description
Number of procedure-related complications from the time of the ablation until the last follow-up visit.
Time Frame
One year
Title
Efficacy primary outcome: typical atrial flutter recurrence.
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Valverde Soria
Phone
687198597
Email
lauravalverdesoria@gmail.com
Facility Information:
Facility Name
Hospital General Doctor Balmis Alicante
City
Alicante
State/Province
A
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Valverde Soria
Phone
+34687198597
Email
lauravalverdesoria@gmail.com
Ext
Valverde Soria
Email
lauravalverdesoria@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Valverde Soria, MD
First Name & Middle Initial & Last Name & Degree
Alicia Ibáñez Criado, MD
First Name & Middle Initial & Last Name & Degree
Thomas Brouzet, MD
First Name & Middle Initial & Last Name & Degree
Amaya García Fernández, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laura García Cano, MD
First Name & Middle Initial & Last Name & Degree
Marta Herrero Brocal, MD
First Name & Middle Initial & Last Name & Degree
Ana García Barrios, MD
First Name & Middle Initial & Last Name & Degree
Jose Luis Ibáñez Criado, MD, PhD
First Name & Middle Initial & Last Name & Degree
Raquel Ajo Ferrer, PhD
First Name & Middle Initial & Last Name & Degree
María Ajo Ferrer
First Name & Middle Initial & Last Name & Degree
Ángela Carrillo Molina

12. IPD Sharing Statement

Learn more about this trial

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

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