Intracardiac Echocardiography-Guided Cavotricuspid Isthmus Ablation With a Circular-Shaped Pulsed Field Ablation Catheter

NCT07353775 | Recruiting

• 1 other identifier: PFA-CTI ablation
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate the effectiveness and safety of a circular-shaped pulsed field ablation (PFA) catheter for CTI ablation under the guidance of intracardiac echocardiography (ICE). The main question it aims to answer is: Is the circular-shaped PFA catheter an effective and safe tool for achieving acute success for CTI ablation? Patients undergoing CTI ablation with a circular-shaped PFA catheter will be prospectively enrolled.

Conditions

Atrial Fibrillation (AF); Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• Acute Success of CTI Block

  Bidirectional block was assessed immediately after the last ablation application and re-confirmed at the end of the 20-minute observation period.

  Within the ablation procedure

Secondary Outcomes (5)

• CTI Procedural Time

  Within the ablation procedure

• Total PF Application Time

  Within the ablation procedure

• Number of PFA Applications

  Within the ablation procedure

• Procedure-related Complications

  Within 30 days after the ablation procedure

• Freedom from Any Atrial Arrhythmia

  12 months

Interventions

ICE-guided CTI ablation with PFA PROCEDURE

Cavotricuspid isthmus ablation with a circular-shaped pulsed field ablation catheter guided by intracardiac echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All eligible patients scheduled for CTI ablation at Beijing Anzhen Hospital will be asked to participate in this study.

You may qualify if:

• Paroxysmal or persistent atrial fibrillation
• Aged 18 years or older
• Scheduled for CTI ablation
• Able and willing to provide written informed consent

You may not qualify if:

• Previous CTI ablation
• Significant congenital heart disease or structural anomaly affecting the CTI
• Active intracardiac thrombus
• Pregnancy or lactation
• Severe renal/hepatic insufficiency
• Active systemic infection or sepsis
• Life expectancy of less than 12 months
• Unable to provide written informed consent.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Desmoglein 1

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desmogleins; Desmosomal Cadherins; Cadherins; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors; Autoantigens

Central Study Contacts

Song Zuo, Doctoral

CONTACT

+86-18801427775; song_zuo@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: January 20, 2026
• Study Start: January 15, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

CN (1)