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

Sponsor

Jose Luis Ibañez Criado (Other)

Overall Status

Recruiting

CT.gov ID

NCT05777850

Collaborator

(none)

120

Enrollment

Location

Arms

29.2

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Typical Atrial Flutter Catheter Ablation	Procedure: Conventional cavotricuspid isthmus ablation Procedure: High-power short-duration ablation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 25, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General Doctor Balmis Alicante	Alicante	A	Spain	03010

Sponsors and Collaborators

Jose Luis Ibañez Criado

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose Luis Ibañez Criado, Medical Doctor, Hospital General Universitario de Alicante

ClinicalTrials.gov Identifier:

NCT05777850

Other Study ID Numbers:

FASD-HP trial

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jose Luis Ibañez Criado, Medical Doctor, Hospital General Universitario de Alicante

Typical Atrial Flutter Cavotricuspid Isthmus

Cavotricuspid Isthmus

High-Power Short-Duration

Additional relevant MeSH terms:

Atrial Flutter

Study Results

No Results Posted as of Mar 21, 2023