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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients above 18 years of age undergoing CTI ablation

Locations
Other Locations
Greece
Mitera General Hospital
RECRUITING
Athens
Contact Information
Primary
Stylianos Tzeis, MD, PhD, FEHRA
stzeis@hyeia.gr
+302106869777
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 96
Treatments
Active_comparator: CTI radiofrequency ablation with lattice-tip catheter
Patients undergoing CTI catheter ablation using RF energy delivered by the lattice-tip, dual-energy catheter (Sphere-9, Medtronic).
Active_comparator: CTI radiofrequency ablation performed with irrigated-tip catheter
Patients undergoing CTI catheter ablation using RF energy delivered by the irrigated RF catheter (ThermoCool® SmartTouch™, Biosense Webster, USA).
Related Therapeutic Areas
Sponsors
Leads: Mitera Hospital

This content was sourced from clinicaltrials.gov