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

NCT07078760 | Completed Results

• 1 other identifier: 833α/ΔΣ
• Study Type: interventional
• Target: 102
• 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)

• Number of Participants With Achievement of Bidirectional CTI Block After 60 Min Waiting Period Documented by High Resolution Activation Mapping

  The primary procedural endpoint for efficacy will be the achievement of bidirectional CTI block after a 60 minute waiting period assessed by high resolution activation mapping and adenosine testing.

  60 minutes

Secondary Outcomes (5)

• Number of Participants With First-pass CTI Block

  Intraproceduraly

• Total Ablation Time

  Intraproceduraly

• Number of Ablation Lesions

  Intraproceduraly

• Total Fluoroscopy Time

  From randomization to the end of the index procedure

• Total Fluoroscopy Dose

  From randomization to the end of the index procedure

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

Location

Related Publications (1)

• Tzeis S, Asvestas D, Sousonis V, Vavouris E, Karakasis P, Charitos D, Karanikas S, Pamporis K, Vardas P, Vlachos K. Lattice-tip vs. standard irrigated focal-tip catheter for radiofrequency ablation of the cavotricuspid isthmus - the LINEAR randomized trial. Europace. 2026 Mar 30;28(4):euag046. doi: 10.1093/europace/euag046.

  PMID: 41978969 DERIVED

Results Point of Contact

• Title: Stylianos Tzeis
• Organization: Mitera Hospital

stzeis@otenet.gr

00302106869777

Study Officials

• Stylianos Tzeis, MD, PhD, FEHRA

  Mitera Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 11, 2025
• Study Completion: December 11, 2025
• Last Updated: June 17, 2026
• Results First Posted: June 17, 2026

Record last verified: 2026-05

Locations

GR (1)