Atrial Fibrillation (AF)HPSD-EsophagusNCT06617442
Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings
A study testing Pulmonary vein isolation in people with Atrial Fibrillation (AF) and Esophageal Perforation, run by Semmelweis University at 1 site in Hungary.
Trial summary
Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation (AF), Esophageal Perforation, Esophageal Perforation, Traumatic
- What is being tested?
- Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 16 Feb 2022to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with paroxysmal or persistent atrial fibrillation undergoing their first pulmonary vein isolation procedure
Who cannot join
- Additional ablation performed outside PVI
- Contraindications to postoperative upper endoscopy
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Heart and Vascular Center
Budapest, Hungary, 1122
About this study
Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation. High power short duration (HPSD) and very high power short duration e.g., 90W and 4 sec) are increasingly popular technologies, featuring higher power and shorter application durations compared to previous methods. vHPSD offers similar efficacy to HPSD, while further reducing procedure times. Atrioesophageal fistula (AEF) is a rare but deadly complication of PVI, while endoscopically detected esophageal lesions are surrogate markers for the risk of AEF. Furthermore, thermal complications include vagal lesions leading to gastroparesis. While there is considerable data on the thermal safety of HPSD technology, most studies of vHPSD focus on efficacy and a direct comparison in terms of esophageal safety is lacking. In this randomized, single-center study, we aim to compare the thermal safety of vHPSD to HPSD. Furthermore, we aimed to determine the anatomical and biophysical factors that predict thermal injury. Patients undergoing their first PVI for AF are randomized to either HPSD or vHPSD power setting. The primary endpoint of the study is the composite of esophageal mucosal lesion and gastroparesis, as assessed at the post-procedural endoscopy within 15 days after the PVI.
- Being tested
- Pulmonary vein isolation
- Keywords
- Pulmonary Vein Isolation, PVI, HPSD, High Power Short Duration, Esophageal injury
- Medical subject headings
- Atrial Fibrillation, Esophageal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
First pulmonary vein isolation performed for atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| 90W | Experimental | Pulmonary vein isolation performed using very-high power short duration applications (90-watt applications lasting 4 seconds). Receives: Procedure: Pulmonary vein isolation |
| 50W | Active comparator | Pulmonary vein isolation performed using high power short duration applications (50-watt applications guided by ablation index). Receives: Procedure: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal injury detected during post-procedural endoscopy
Composite of esophageal ulcer or erosion and gastric hypomotility.
Measured: Post-procedural endoscopy was performed within 15 days after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start16 Feb 2022
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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
- Randomized, open label
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nandor Szegedi, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617442
- Sponsor's protocol ID
- 8088-2/2022/EÜIG
- Acronym
- HPSD-Esophagus
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Komlosi F, Nagy KV, Perge P, Sallo Z, Osztheimer I, Tanai E, Toth P, Orban G, Ferencz AB, Boga M, Hizoh I, Papp V, Hritz I, Szijarto A, Boussoussou M, Merkely B, Geller L, Szegedi N. Oesophageal safety of high and very high power short duration pulmonary vein isolation: a randomized comparison of the 50 W and 90 W power settings-the HPSD oesophagus study. Eur Heart J Open. 2026 Feb 25;6(2):oeag041. doi: 10.1093/ehjopen/oeag041. eCollection 2026 Mar.
PubMed 41918770
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings
- ClinicalTrials.gov ID
- NCT06617442
- Acronym / sponsor ID
- HPSD-Esophagus / 8088-2/2022/EÜIG
- Keywords
- Pulmonary Vein Isolation, PVI, HPSD, High Power Short Duration, Esophageal injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 27 Sep 2024 (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.
Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation. High power short duration (HPSD) and very high power short duration e.g., 90W and 4 sec) are increasingly popular technologies, featuring higher power and shorter application durations compared to previous methods. vHPSD offers similar efficacy to HPSD, while further reducing procedure times. Atrioesophageal fistula (AEF) is a rare but deadly complication of PVI, while endoscopically detected esophageal lesions are surrogate markers for the risk of AEF. Furthermore, thermal complications include vagal lesions leading to gastroparesis. While there is considerable data on the thermal safety of HPSD technology, most studies of vHPSD focus on efficacy and a direct comparison in terms of esophageal safety is lacking. In this randomized, single-center study, we aim to compare the thermal safety of vHPSD to HPSD. Furthermore, we aimed to determine the anatomical and biophysical factors that predict thermal injury. Patients undergoing their first PVI for AF are randomized to either HPSD or vHPSD power setting. The primary endpoint of the study is the composite of esophageal mucosal lesion and gastroparesis, as assessed at the post-procedural endoscopy within 15 days after the PVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, open label
| Arm | Type | Receives |
|---|---|---|
| 90W | Experimental | Procedure: Pulmonary vein isolationPulmonary vein isolation performed using very-high power short duration applications (90-watt applications lasting 4 seconds). |
| 50W | Active comparator | Procedure: Pulmonary vein isolationPulmonary vein isolation performed using high power short duration applications (50-watt applications guided by ablation index). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with paroxysmal or persistent atrial fibrillation undergoing their first pulmonary vein isolation procedure
Key exclusion criteria (2 listed)
- Additional ablation performed outside PVI
- Contraindications to postoperative upper endoscopy
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 |
|---|---|---|
| Pulmonary vein isolationFirst pulmonary vein isolation performed for atrial fibrillation. | Procedure or surgery | 50W, 90W |
Primary outcome
Thermal injury detected during post-procedural endoscopy
Time frame: Post-procedural endoscopy was performed within 15 days after the procedure.
Composite of esophageal ulcer or erosion and gastric hypomotility.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 41918770Komlosi F, Nagy KV, Perge P, Sallo Z, Osztheimer I, Tanai E, Toth P, Orban G, Ferencz AB, Boga M, Hizoh I, Papp V, Hritz I, Szijarto A, Boussoussou M, Merkely B, Geller L, Szegedi N. Oesophageal safety of high and very high power short duration pulmonary vein isolation: a randomized comparison of the 50 W and 90 W power settings-the HPSD oesophagus study. Eur Heart J Open. 2026 Feb 25;6(2):oeag041. doi: 10.1093/ehjopen/oeag041. eCollection 2026 Mar.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation in people with Atrial Fibrillation (AF) and Esophageal Perforation, run by Semmelweis University at 1 site in Hungary.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Sep 2024. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal injury detected during post-procedural endoscopy (time frame: Post-procedural endoscopy was performed within 15 days after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06617442, which also lists 1 linked publication.
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 27 Sep 2024.