Cardiac Ablation Clinical Trials

Clinical trials related to Cardiac Ablation Procedure

Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation

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

This study evaluates whether re-sterilized (reprocessed) ablation catheters are as effective and safe as new ablation catheters when used for pulmonary vein isolation in patients with atrial fibrillation. Adult patients scheduled for catheter ablation will be randomly assigned to undergo the procedure using either a new catheter or a re-sterilized catheter, with identical procedural techniques applied in both groups. The study will compare procedural efficiency, safety, costs, and environmental impact between the two approaches. The results may support more sustainable and cost-effective use of medical devices in cardiac electrophysiology.

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

• Age ≥ 18 years

• Paroxysmal or persistent atrial fibrillation documented by ECG or Holter ECG monitoring

• Indication for pulmonary vein isolation according to current clinical guidelines

• Written informed consent

Locations
Other Locations
Croatia
UH Dubrava
RECRUITING
Zagreb
Contact Information
Primary
Ivan Zeljković, PhD,MD
ivanzeljkov@gmail.com
+385917823289
Backup
Mihovil Santini, MD
023miho@gmail.com
+385958101778
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2027-08-20
Participants
Target number of participants: 200
Treatments
Experimental: Reprocessed Catheter (Experimental)
Participants will undergo pulmonary vein isolation using a reprocessed electroporation ablation catheter. The catheter has undergone validated cleaning, re-sterilization, and functional testing in accordance with applicable regulatory and safety standards. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the comparator arm.
Active_comparator: New Catheter (Active Comparator)
Participants will undergo pulmonary vein isolation using a new electroporation ablation catheter. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the experimental arm.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Dubrava

This content was sourced from clinicaltrials.gov