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This study evaluates whether re-sterilized (reprocessed) ablation catheters are as effective and safe as new ablation catheters when used for electrophysiological procedures. 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.
This is a prospective, randomized, controlled non-inferiority trial comparing re-sterilized (reprocessed) and new ablation catheters in electrophysiological procedures. The study will be conducted at University Hospital Dubrava, a high-volume tertiary center for cardiac electrophysiology.
Patients scheduled for electrophysiological procedures will be randomized in a 1:1 ratio using a computer-generated sequence to undergo ablation with either a new or a re-sterilized catheter. All procedures will be performed by experienced electrophysiologists in accordance with standard institutional practice.
Procedure duration will be measured from groin puncture to completion of ablation. Additional procedural parameters related to ablation delivery, including duration and number of energy applications, total ablation time, and other procedural timing characteristics, will also be recorded. Fluoroscopy time and radiation dose, expressed as dose-area product (DAP), will be recorded automatically.
Catheter performance will be assessed based on achievement ablation, the number of energy applications and procedural assessment of catheter integrity, flexibility, and electrical properties.
Procedural safety will be evaluated by monitoring peri-procedural and post-procedural adverse events, including pericardial effusion, stroke, vascular complications, and death. Laboratory markers of inflammation, infection, and hemolysis will be obtained at predefined time points before and after the procedure. Blood cultures will be collected before and after the procedure to assess potential infectious complications.
Patients will be followed clinically during hospitalization and after discharge through telephone contact and routine outpatient visits.
Economic evaluation will include direct procedural costs, catheter costs, and re-sterilization costs. Environmental impact will be assessed based on medical waste generation and estimated carbon footprint associated with catheter use.
Re-sterilization of ablation catheters will be performed according to the validated internal protocol of University Hospital Dubrava, which has been used in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reprocessed Catheter (Experimental) | Experimental | Participants will undergo electrophysiological procedure (ablation) using a reprocessed 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. |
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| New Catheter (Active Comparator) | Active Comparator | Participants will undergo electrophysiological procedure (ablation) using a new ablation catheter. Procedural technique, energy delivery protocol, and peri-procedural management will be identical to those used in the comparator arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation - new | Procedure | Participants will undergo electrophysiological procedure (ablation). The intervention consists of the use a new ablation catheter. The key distinguishing feature of this intervention is the comparison of reprocessed versus new single-use catheters, while all other procedural aspects, including operator technique, energy delivery protocol, and peri-procedural care, are standardized and identical between groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation duration | Procedure duration, expressed in minutes, measured from groin puncture to completion of ablation. | From the start of the index ablation procedure until its completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success | Successful completion of ablation defined as achievement of electrical isolation of the target tissue | From the start of the index ablation procedure until its completion |
| Medical Waste Generated Per Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Zeljković, PhD,MD | Contact | +385917823289 | ivanzeljkov@gmail.com | |
| Mihovil Santini, MD | Contact | +385958101778 | 023miho@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Dubrava | Zagreb | 10000 | Croatia |
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The study is designed as a prospective, randomized, controlled non-inferiority trial with a parallel-group design, comparing resterilized (reprocessed) and new ablation catheters used in electrophysiological procedures. Participants will be randomly assigned to two groups, with one group undergoing ablation using new catheters and the other using resterilized catheters, while the procedural protocol will be identical in both groups. The primary endpoint is procedure duration, expressed in minutes. Secondary endpoints include catheter functionality, fluoroscopy time and radiation dose, peri- and post-procedural complications, procedural safety, procedural costs, and assessment of environmental impact.
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| Ablation - reprocessed | Procedure | Participants will undergo electrophysiological procedure (ablation). The intervention consists of the use of a reprocessed ablation catheter. The reprocessed catheter has undergone validated cleaning, resterilization, and functional testing in accordance with regulatory and safety standards prior to reuse. The key distinguishing feature of this intervention is the comparison of reprocessed versus new single-use catheters, while all other procedural aspects, including operator technique, energy delivery protocol, and peri-procedural care, are standardized and identical between groups. |
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Amount of medical waste generated per ablation procedure, expressed in kilograms.
| Periprocedural |
| Fluoroscopy Time | Total fluoroscopy time, expressed in minutes, recorded during the ablation procedure. | From the start of the index ablation procedure until its completion |
| Radiation Dose (Dose-Area Product) | Radiation exposure expressed as dose-area product (DAP), automatically recorded during the ablation procedure. | From the start of the index ablation procedure until its completion |
| Incidence of Peri- and Post-Procedural Complications | Number of participants with peri-procedural and post-procedural complications, including pericardial effusion, stroke, vascular complications, and death. | Up to 30 days following the index ablation procedure |
| Direct Procedural Costs Per Patient | Direct procedural costs per patient, including catheter cost, procedure-related costs, and re-sterilization costs, expressed in local currency. | Periprocedural |
| Estimated Carbon Footprint Per Procedure | Estimated carbon footprint associated with the ablation procedure and catheter use, expressed in CO₂-equivalent units. | From the start of the index ablation procedure until its completion. |