Lattice-tip Versus Irrigated-tip Catheter for Linear Ablation of the Cavotricuspid Isthmus. A Multicenter, Randomized Study.

NCT07078760 | Recruiting

• 1 other identifier: 833α/ΔΣ
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The LINEAR study is designed to compare the procedural efficacy, efficiency and safety of linear radiofrequency ablation of the cavotricuspid istmus using either a standar irrigated-tip ablation catheter or lattice-tip ablation catheter .The primary focus of the acute procedural data analysis will be: Procedural efficacy: This will be evaluated based on the rate of bidirectional CTI block persistence after 60 min waiting period documented by high resolution activation mapping. Furthermore, provocative test with intravenous adenosine infusion will be conducted to exclude dormant CTI conduction. Procedural efficiency: This will be evaluated based on the number of RF lesions delivered, time to achieve bidirectional CTI block, and fluoroscopy exposure time. Procedural safety: The incidence of procedural complications will be recorded.

Conditions

Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• The primary procedural endpoint for efficacy will be the achievement of bidirectional CTI block after 60 min waiting period documented by high resolution activation mapping . The primary safety endpoint will be the incidence of procedural complications.

  The primary procedural endpoint for efficacy will be the achievement of bidirectional CTI block. After completion of the CTI line, bidirectional block will be confirmed through differential pacing maneuvers followed by activation mapping, performed using the Affera mapping system for Group A and the CARTO mapping system for Group B, respectively. Activation mapping will be repeated 60 minutes after the initial documentation of bidirectional block to assess for its persistence or the presence of spontaneous recovery of CTI conduction. In the absence of spontaneous recovery, a provocative test involving intravenous adenosine infusion will be conducted to evaluate for dormant CTI conduction. During the adenosine infusion and the resultant transient atrioventricular block or sinus pause, bidirectional block will be reassessed using differential pacing maneuvers with the mapping catheter positioned laterally to the ablation line.The incidence of procedural complications will be recorded.

  60 minutes

Study Arms (2)

CTI radiofrequency ablation with lattice-tip catheter

ACTIVE COMPARATOR

Patients undergoing CTI catheter ablation using RF energy delivered by the lattice-tip, dual-energy catheter (Sphere-9, Medtronic).

Procedure: CTI radiofrequency ablation.

CTI radiofrequency ablation performed with irrigated-tip catheter

ACTIVE COMPARATOR

Patients undergoing CTI catheter ablation using RF energy delivered by the irrigated RF catheter (ThermoCool® SmartTouch™, Biosense Webster, USA).

Procedure: CTI radiofrequency ablation.

Interventions

CTI radiofrequency ablation. PROCEDURE

Cavotricuspid Isthmus ablation

CTI radiofrequency ablation performed with irrigated-tip catheter; CTI radiofrequency ablation with lattice-tip catheter

Eligibility Criteria

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

You may qualify if:

• patients above 18 years of age undergoing CTI ablation

You may not qualify if:

• Prior right atrium ablation

Sponsors & Collaborators

• Mitera Hospital: lead

Study Sites (1)

Mitera General Hospital

Athens, Attikis, 11523, Greece

RECRUITING

Study Officials

• Stylianos Tzeis, MD, PhD, FEHRA

  Mitera Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stylianos Tzeis, MD, PhD, FEHRA

CONTACT

+302106869777; stzeis@hyeia.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FEHRA, Cardiologist - Electrophysiologist

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 22, 2025
• Study Start: June 16, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

GR (1)