Long-term outcomeS of cavotrIcuspid isthMus-dePendent fLuttEr Ablation: Single vs Double Catheter Procedure

Not Applicable

Completed

• Conditions: Atrial Flutter
• Interventions: Procedure: Traditional approach; Procedure: Single catheter approach

• Registration Number: NCT04472936
• Lead Sponsor: Centro Medico Teknon

Brief Summary

Catheter ablation is recommended as first-line therapy for most patients with typical atrial flutter. The most common approach is to create an ablation line across the cavotricuspid isthmus (CTI). Traditionally, atrial flutter ablation has been performed with a conventional approach using two catheters, an ablation catheter and a duodecapolar catheter that is placed at the level of the tricuspid annulus to confirm the CTI block. Recently, a single catheter approach has been described using the behavior of PR interval change during differential pacing over the ablation line to prove CTI block. This prospective, randomized, multicenter study analyzes the effectivity of a single catheter approach compared with conventional approach in terms of clinical outcomes.

Detailed Description

Typical atrial flutter is a reentrant rhythm in the right atrium that is constrained anteriorly by the tricuspid annulus and posteriorly by the crista terminalis and eustachian ridge. Catheter ablation is the first-line therapy for most patients with typical atrial flutter. The most common approach is to create an ablation line across the CTI, from the tricuspid annulus to the inferior vena cava. Traditionally, atrial flutter ablation has been performed with a conventional approach using two catheters, an ablation catheter and a duodecapolar catheter that is placed at the level of the tricuspid annulus that allows to evaluate the right atrial activation sequence to confirm the CTI block. Recently, a single catheter approach has been described using the behavior of PR interval (PRI) change during differential pacing over the ablation line to prove CTI block. The PRIs is measured for three different pacing site, 5 o'clock (medial to CTI line), 7 o'clock (lateral to CTI line), and 9 o'clock position. CTI block was assumed when the PRI at 7 o'clock was \>80ms longer than that at pacing sites of 5 o'clock and the PRI at 9 o'clock was shorter than the PRI at 7 o'clock. However, a direct comparison between this approach and the conventional one was not yet performed. This prospective, randomized, multicenter study analyzes the effectivity of a single catheter approach compared with conventional approach in terms of clinical outcomes. Our research hypothesis is that a single catheter approach has the possible advantages of being a faster, more efficient and cheaper procedure than the conventional approach. Moreover, as it only requires a single venous access, the risk of complications is decreased.

Study Timeline

• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-07-12
• Study Start: 2020-07-16
• Study First Posted: 2020-07-16
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

• Patients admitted at any of the centers to perform a CTI ablation.
• Signed informed consent

Exclusion Criteria

• Age < 18 years.
• Pregnancy.
• Impossibility to perform CTI ablation.
• Impossibility to measure PRI (complete atrioventricular block).
• Ablation of other cardiac arrhythmias during the same procedure.
• Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Traditional approach	Double venous femoral access will be obtained. A duodecapolar catheter placed around tricuspid annulus will be used to prove isthmus block after CTI ablation.
Group B	Single catheter approach	Ablation will be performed similar as described in the Group A. After the ablation line is over, PRI on the surface ECG will be used to prove isthmus block after CTI ablation.

Primary Outcome Measures

Name	Time	Method
Clinical outcomes	6 months	The recurrence rate of typical atrial flutter at 6 months post cavotricuspid isthmus ablation will be evaluated in both groups to determine if the single catheter approach is non-inferior when compared to traditional approach using two catheters.

Secondary Outcome Measures

Name	Time	Method
Efficiency in ablation time	6 months	The ablation time will be measured in both groups to determine if the single catheter approach is more efficient procedure.
Efficiency in fluoroscopy time	6 months	The fluoroscopy time will be measured in both groups to determine if the single catheter approach is more efficient procedure.
Cost-effectiveness	6 months	We will perform a cost-effectiveness analysis.
Efficiency in total procedure time	6 months	The total procedure time time will be measured in both groups to determine if the single catheter approach is more efficient procedure.
Complications	6 months	We will compare the complication rate of both approaches.

Trial Locations

Locations (3)

Virgen del Rocio University Hospital; 🇪🇸 Sevilla, Spain

Puerta del Mar University Hospital; 🇪🇸 Cadiz, Spain

Centro Medico Teknon; 🇪🇸 Barcelona, Spain