Reprocessed versus new ablation catheters for pulmonary vein isolation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UH Dubrava
  Zagreb, Croatia Recruiting

Study contacts

• Study coordinator: Ivan Zeljković, PhD,MD
• Email: ivanzeljkov@gmail.com
• Phone: +385917823289

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.