Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation

NCT06691074 | Recruiting

• 2 other identifiers: 28518/24; A-24-24SECTION trial
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to assess the acute durability of the CTI block when PEF energy is used. Second goal is to establish the optimal waiting time for the conduction recovery after PEF CTI ablation and to assess the utility of routine adenosine testing for dormant conduction. Moreover, this study aims to investigate the differences in acute efficacy and adverse events (hemolysis, coronary vasospasm) between the two available configurations (basket or flower) of the pentaspline Farawave catheter (Farapulse-Boston Scientific Inc, USA).

Conditions

Flutter, Atrial; Cavotricuspid Isthmus Dependent Right Atrial Flutter; Catheter Ablation

Keywords

Pulsed Electric Field; Cavo-tricuspid Isthmus; Biderectional Block

Outcome Measures

Primary Outcomes (1)

• The acute durability of the CTI block

  The primary goal of this study is to assess the acute durability of the CTI block when PEF energy is used. The bidirectional block on the CTI will be demonstrated with standard pacing manoeuvres (differential pacing from duodecapolar catheter and proximal CS).

  During the ablation procedure

Secondary Outcomes (4)

• The optimal waiting time for the conduction recovery after PEF CTI ablation

  During the procedure

• The utility of routine adenosine testing for dormant conduction on the CTI

  During the ablation procedure.

• Concentration of plasma free haemoglobin

  During the ablation procedure

• The presence of the coronary vasospasm

  During the ablation procedure

Study Arms (2)

Flower configuration

ACTIVE COMPARATOR

Ablation of the CTI using a Farapulse catheter in flower configuration

Procedure: Catheter ablation of cavotricuspid isthmus using flower configuration of the Farapulse catheter

Basket configuration

ACTIVE COMPARATOR

Ablation of the CTI using a Farapulse catheter in basket configuration

Procedure: Catheter ablation of cavotricuspid isthmus using basket configuration of the Farapulse catheter

Interventions

Catheter ablation of cavotricuspid isthmus using flower configuration of the Farapulse catheter PROCEDURE

catheter ablation

Flower configuration

Catheter ablation of cavotricuspid isthmus using basket configuration of the Farapulse catheter PROCEDURE

Catheter ablation of cavotricuspid isthmus using basket configuration of the Farapulse catheter

Basket configuration

Eligibility Criteria

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

You may qualify if:

• patients with paroxysmal AF undergoing PVI by PEF energy with documented typical atrial flutter or patients with persistent AF in whom catheter ablation of CTI is planned as a part of a complex procedure
• Age ≥ 18 years at the time of study enrollment
• Signed informed consent

You may not qualify if:

• \- LA diameter \> 65 mm (measured in the parasternal long-axis view)
• History of CTI ablation in the past
• History of cardiac valve surgery
• Significant valvular defect
• Age below 18 years
• Pregnancy, breastfeeding
• Any disease with a life expectancy \<1 year
• Uncorrected congenital heart disease or valvular obstruction
• Active myocarditis
• Untreated hypothyroidism or hyperthyroidism
• Recipient of any major organ transplant (e.g., lung, liver, heart)
• HIV positivity with a survival expectancy of less than five years due to HIV
• Chronic dialysis treatment
• Unwillingness to participate.

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Prague, 14200, Czechia

RECRUITING

Related Publications (3)

• Morales G, Darrat YH, Lellouche N, Kim SM, Butt M, Bidwell K, Lippert W, Ogunbayo G, Hamon D, Di Biase L, Natale A, Parrott K, Elayi CS. Use of adenosine to shorten the post ablation waiting period for cavotricuspid isthmus-dependent atrial flutter. J Cardiovasc Electrophysiol. 2017 Aug;28(8):876-881. doi: 10.1111/jce.13233. Epub 2017 May 29.

  PMID: 28429528 BACKGROUND

• Yoneda ZT, Shoemaker MB, Richardson T, Crawford D, Kanagasundram A, Shen S, Estrada JC, Holmes B, Lugo R, McHugh J, Saavedra P, Crossley G 3rd, Ellis CR, Montgomery JA, Michaud GF. Conduction Recovery After Cavotricuspid Isthmus Ablation When Performed With or Without Concomitant Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Aug;6(8):989-996. doi: 10.1016/j.jacep.2020.04.031.

  PMID: 32819535 BACKGROUND

• Chen J, de Chillou C, Ohm OJ, Hoff PI, Rossvoll O, Andronache M, Sadoul N, Magnin-Poull I, Erga KS, Aliot E. Acute resumption of conduction in the cavotricuspid isthmus after catheter ablation in patients with common atrial flutter. Real-time evaluation and long-term follow-up. Europace. 2002 Jul;4(3):255-63. doi: 10.1053/eupc.2002.0243.

  PMID: 12134971 BACKGROUND

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: November 15, 2024
• Study Start: September 16, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CZ (1)