Reprocessed versus new ablation catheters for pulmonary vein isolation
Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation
NA · University Hospital Dubrava · NCT07389434
This will test whether re-sterilized (reprocessed) ablation catheters work as well and are as safe as new catheters for adults having pulmonary vein isolation for atrial fibrillation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Dubrava (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT07389434 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled non-inferiority trial at a high-volume tertiary center comparing reprocessed and new electroporation ablation catheters for pulmonary vein isolation. Adult patients with paroxysmal or persistent atrial fibrillation scheduled for PVI are randomized 1:1 to undergo pulsed field ablation with either a new or a reprocessed catheter using identical procedural techniques. The study records procedure duration, ablation delivery metrics, fluoroscopy time and dose, catheter performance measures, peri- and post-procedural adverse events, and laboratory inflammation markers. It also compares costs and environmental impact metrics between the two approaches.
Who should consider this trial
Good fit: Adults (≥18 years) with paroxysmal or persistent atrial fibrillation who have an indication for pulmonary vein isolation and can give informed consent are ideal candidates.
Not a fit: Patients with severe valvular disease, significant structural heart disease that precludes pulsed field ablation, pregnancy, breastfeeding, or life expectancy under 12 months are unlikely to benefit from participation.
Why it matters
Potential benefit: If reprocessed catheters perform similarly to new ones, patients could benefit from lower procedure costs and reduced medical waste without loss of safety or effectiveness.
How similar studies have performed: Reprocessing of some medical devices has been studied previously, but randomized non-inferiority data specifically for reprocessed electroporation (PFA) ablation catheters are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Severe valvular heart disease * Significant structural heart disease that precludes pulsed field ablation (PFA) * Pregnancy or breastfeeding * Life expectancy \< 12 months
Where this trial is running
Zagreb
- UH Dubrava — Zagreb, Croatia (RECRUITING)
Study contacts
- Study coordinator: Ivan Zeljković, PhD,MD
- Email: ivanzeljkov@gmail.com
- Phone: +385917823289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Catheter Ablation, Electroporation, Catheter Reprocessing, Cost-Benefit Analysis, Medical Waste, Environmental Impact