Atrial Fibrillation (AF)RE-USE PVINCT07389434
Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in PVI
A study testing Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor in people with Atrial Fibrillation (AF), run by University Hospital Dubrava at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 5 Feb 2026to 20 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe valvular heart disease
- Significant structural heart disease that precludes pulsed field ablation (PFA)
- Pregnancy or breastfeeding
- Life expectancy < 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
UH Dubrava
Zagreb, 10000
Ivan Zeljković, MD, Phd
Mihovil Santini, MD
About this study
Official title: Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation
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.
Read the detailed description
This is a prospective, randomized, controlled non-inferiority trial comparing re-sterilized (reprocessed) and new ablation catheters for pulmonary vein isolation in patients with atrial fibrillation. The study will be conducted at University Hospital Dubrava, a high-volume tertiary center for cardiac electrophysiology.
Patients scheduled for pulmonary vein isolation 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 transseptal puncture to completion of ablation of all pulmonary veins. 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 of complete pulmonary vein isolation, the number of energy applications per pulmonary vein, 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 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor
- Keywords
- Atrial Fibrillation, Catheter Ablation, Electroporation, Catheter Reprocessing, Cost-Benefit Analysis, Medical Waste, Environmental Impact
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electroporProcedure or surgery
This intervention involves pulmonary vein isolation performed with ablation catheter that is either new or reprocessed. 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.
| Study group | Role | What they receive |
|---|---|---|
| Reprocessed Catheter (Experimental) | 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. Receives: Procedure: Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor |
| New Catheter (Active Comparator) | 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. Receives: Procedure: Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Vein Isolation Procedure Duration
Procedure duration, expressed in minutes, measured from transseptal puncture to completion of ablation of all pulmonary veins. Additional procedural parameters, including duration of individual procedural segments, total ablation time, number and duration of energy applications, and other time-related procedural characteristics, will also be recorded.
Measured: From the start of the index ablation procedure until its completion.
Secondary outcomes (7)
Procedural Catheter Performance Parameters
Catheter functional performance assessed by successful pulmonary vein isolation, number of energy applications per pulmonary vein, total ablation time, and procedural assessment of catheter integrity and flexibility.
Measured: From the start of the index ablation procedure until its completion
Medical Waste Generated Per Procedure
Amount of medical waste generated per ablation procedure, expressed in kilograms.
Measured: Periprocedural
Fluoroscopy Time
Total fluoroscopy time, expressed in minutes, recorded during the ablation procedure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Periprocedural
Estimated Carbon Footprint Per Procedure
Estimated carbon footprint associated with the ablation procedure and catheter use, expressed in CO₂-equivalent units.
Measured: From the start of the index ablation procedure until its completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a prospective, randomized, controlled non-inferiority trial with a parallel-group design, comparing resterilized (reprocessed) and new electroporation ablation catheters used for pulmonary vein isolation in patients with atrial fibrillation. 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Zeljkovic, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389434
- Sponsor's protocol ID
- 2025/1024-3
- Acronym
- RE-USE PVI
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as no formal data-sharing plan has been established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety, Cost-effectiveness, and Environmental Impact of Reprocessed Ablation Catheters in Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT07389434
- Acronym / sponsor ID
- RE-USE PVI / 2025/1024-3
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Catheter Ablation, Electroporation, Catheter Reprocessing, Cost-Benefit Analysis, Medical Waste, Environmental Impact
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, controlled non-inferiority trial comparing re-sterilized (reprocessed) and new ablation catheters for pulmonary vein isolation in patients with atrial fibrillation. The study will be conducted at University Hospital Dubrava, a high-volume tertiary center for cardiac electrophysiology.
Patients scheduled for pulmonary vein isolation 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 transseptal puncture to completion of ablation of all pulmonary veins. 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 of complete pulmonary vein isolation, the number of energy applications per pulmonary vein, 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is designed as a prospective, randomized, controlled non-inferiority trial with a parallel-group design, comparing resterilized (reprocessed) and new electroporation ablation catheters used for pulmonary vein isolation in patients with atrial fibrillation. 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.
| Arm | Type | Receives |
|---|---|---|
| Reprocessed Catheter (Experimental) | Experimental | Procedure: Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electroporParticipants 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. |
| New Catheter (Active Comparator) | Active comparator | Procedure: Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electroporParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Severe valvular heart disease
- Significant structural heart disease that precludes pulsed field ablation (PFA)
- Pregnancy or breastfeeding
- Life expectancy < 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electroporThis intervention involves pulmonary vein isolation performed with ablation catheter that is either new or reprocessed. 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. | Procedure or surgery | New Catheter (Active Comparator), Reprocessed Catheter (Experimental) |
Primary outcome
Pulmonary Vein Isolation Procedure Duration
Time frame: From the start of the index ablation procedure until its completion.
Procedure duration, expressed in minutes, measured from transseptal puncture to completion of ablation of all pulmonary veins. Additional procedural parameters, including duration of individual procedural segments, total ablation time, number and duration of energy applications, and other time-related procedural characteristics, will also be recorded.
7 secondary outcomes
Procedural Catheter Performance Parameters
Time frame: From the start of the index ablation procedure until its completion
Medical Waste Generated Per Procedure
Time frame: Periprocedural
Fluoroscopy Time
Time frame: From the start of the index ablation procedure until its completion
Radiation Dose (Dose-Area Product)
Time frame: From the start of the index ablation procedure until its completion
Incidence of Peri- and Post-Procedural Complications
Time frame: Up to 30 days following the index ablation procedure
Direct Procedural Costs Per Patient
Time frame: Periprocedural
Estimated Carbon Footprint Per Procedure
Time frame: From the start of the index ablation procedure until its completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as no formal data-sharing plan has been established for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants will undergo pulmonary vein isolation using pulsed field ablation (PFA). The intervention consists of the use of either a reprocessed electroporation ablation catheter or a new electropor in people with Atrial Fibrillation (AF), run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Zeljković, PhD,MD (+385917823289, ivanzeljkov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Vein Isolation Procedure Duration (time frame: From the start of the index ablation procedure until its completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.