Lattice-tip vs. standard irrigated focal-tip catheter for radiofrequency ablation of the cavotricuspid isthmus - the LINEAR randomized trial.
Stylianos Tzeis, Dimitrios Asvestas, Vasileios Sousonis...
https://pubmed.ncbi.nlm.nih.gov/41978969Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07078760
Lattice-tip Versus Irrigated-tip Catheter for Linear Ablation of the Cavotricuspid Isthmus. A Multicenter, Randomized Study.
Led by Mitera Hospital · Updated on 2025-08-27
96
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two types of catheters used for linear radiofrequency ablation of the cavotricuspid isthmus (CTI), an area in the heart. The study aims to evaluate and compare the effectiveness, efficiency, and safety of a lattice-tip dual-energy catheter versus a standard irrigated-tip catheter in patients undergoing CTI ablation. The focus is on how well the ablation creates a lasting bidirectional CTI block, including a test to detect any hidden conduction after 60 minutes, as well as the safety of the procedures. Participants will be randomly assigned to one of two groups: one group will receive ablation using the lattice-tip catheter, and the other will receive ablation using the irrigated-tip catheter. Both groups will undergo the procedure under general anesthesia with pre-procedure anticoagulation and discontinuation of anti-arrhythmic drugs. The ablation will be performed point-by-point along the CTI guided by imaging and mapping tools, with additional intracardiac echocardiography used if needed. Each catheter group will follow specific procedural protocols and settings during the ablation. During the study, participants will be monitored for the primary outcome of bidirectional CTI block persistence after 60 minutes using high-resolution mapping and a provocative adenosine test. Researchers will also record the number of lesions, time to block achievement, fluoroscopy exposure, and any procedural complications. The study is designed to enroll 96 patients, with equal numbers in each catheter group, and no dropouts are expected since the outcome is assessed during the procedure itself.
CONDITIONS
Brief Title
Lattice-tip Versus Irrigated-tip Catheter for Linear Ablation of the Cavotricuspid Isthmus. A Multicenter, Randomized Study.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Scheduled to undergo cavotricuspid isthmus (CTI) ablation
You will not qualify if you...
- History of prior right atrium ablation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Procedure day with 60 minutes of monitoring post-ablation
Participants undergo cavotricuspid isthmus catheter ablation using either a lattice-tip dual-energy catheter or an irrigated radiofrequency catheter to achieve bidirectional CTI block.
1 procedure visit with monitoring during and immediately after the procedure
Trial Site Locations
Total: 1 location
1
Mitera General Hospital
Athens, Attikis, Greece, 11523
Actively Recruiting
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Research Team
S
Stylianos Tzeis, MD, PhD, FEHRA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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