Typical Atrial FlutterFASD-HPNCT05777850
High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
A study testing Conventional cavotricuspid isthmus ablation and High-power short-duration ablation in people with Typical Atrial Flutter and Catheter Ablation, run by Jose Luis Ibañez Criado at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Typical Atrial Flutter, Catheter Ablation
- What is being tested?
- Conventional cavotricuspid isthmus ablation and High-power short-duration ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2022to 9 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cavotricuspid isthmus dependent flutter referred to ablation
- Patients clinically and hemodynamically stable.
- Patients who give informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Typical Atrial Flutter, Catheter Ablation
- Being tested
- Conventional cavotricuspid isthmus ablation, High-power short-duration ablation
- Keywords
- Typical Atrial Flutter Cavotricuspid Isthmus, Cavotricuspid Isthmus, High-Power Short-Duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional cavotricuspid isthmus ablationProcedure or surgery
Point-by-point 25-40 W applications at the CTI of unlimited duration until achieving the pre-established Ablation Index.
High-power short-duration ablationProcedure or surgery
Point-by-point 90W applications at the CTI ablation during 4 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ablation | Active comparator | 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. Receives: Procedure: Conventional cavotricuspid isthmus ablation |
| High-power short-duration ablation | Experimental | 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. Receives: Procedure: High-power short-duration ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start25 Oct 2022
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Typical Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Luis Ibañez Criado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Luis Ibañez Criado, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777850
- Sponsor's protocol ID
- FASD-HP trial
- Acronym
- FASD-HP
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valverde Soria L, Toquero J, Brouzet T, Garcia Cano L, Garcia Barrios A, Segura Dominguez M, Hermon Ramirez GA, Ajo Ferrer R, Ajo Ferrer M, Andreu Concha CM, Arrarte Esteban V, Sanchez Barbie A, Martinez-Martinez JG, Ibanez Criado A, Ibanez Criado JL. Very high-power short-duration radiofrequency ablation in patients with typical atrial flutter: rationale and design of the FASD-HP randomized trial. J Interv Card Electrophysiol. 2025 Apr;68(3):497-503. doi: 10.1007/s10840-024-01969-7. Epub 2024 Dec 21.
PubMed 39708245
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
- ClinicalTrials.gov ID
- NCT05777850
- Acronym / sponsor ID
- FASD-HP / FASD-HP trial
- Conditions
- Typical Atrial Flutter, Catheter Ablation
- Keywords
- Typical Atrial Flutter Cavotricuspid Isthmus, Cavotricuspid Isthmus, High-Power Short-Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Jose Luis Ibañez CriadoUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ablation | Active comparator | Procedure: Conventional cavotricuspid isthmus ablationCTI 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. |
| High-power short-duration ablation | Experimental | Procedure: High-power short-duration ablationCTI 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with cavotricuspid isthmus dependent flutter referred to ablation
- Patients clinically and hemodynamically stable.
- Patients who give informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional cavotricuspid isthmus ablationPoint-by-point 25-40 W applications at the CTI of unlimited duration until achieving the pre-established Ablation Index. | Procedure or surgery | Conventional ablation |
| High-power short-duration ablationPoint-by-point 90W applications at the CTI ablation during 4 seconds. | Procedure or surgery | High-power short-duration ablation |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Derived from this study: PubMed 39708245Valverde Soria L, Toquero J, Brouzet T, Garcia Cano L, Garcia Barrios A, Segura Dominguez M, Hermon Ramirez GA, Ajo Ferrer R, Ajo Ferrer M, Andreu Concha CM, Arrarte Esteban V, Sanchez Barbie A, Martinez-Martinez JG, Ibanez Criado A, Ibanez Criado JL. Very high-power short-duration radiofrequency ablation in patients with typical atrial flutter: rationale and design of the FASD-HP randomized trial. J Interv Card Electrophysiol. 2025 Apr;68(3):497-503. doi: 10.1007/s10840-024-01969-7. Epub 2024 Dec 21.
Related trials for Typical Atrial Flutter
Recruiting
Atrial Flutter Ablation in the iCMR
Atrial Flutter Typical
Not yet recruiting
Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation
Atrial Flutter Typical
Recruiting
Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation
Catheter Ablation, Atrial Flutter Typical
Not yet recruiting
Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications
Ventricular Tachycardia (VT), Atrial Tachycardia
Recruiting
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Typical Atrial Flutter, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional cavotricuspid isthmus ablation and High-power short-duration ablation in people with Typical Atrial Flutter and Catheter Ablation, run by Jose Luis Ibañez Criado at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety primary outcome: incidence of procedure-related complications. (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05777850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.