Paroxysmal Supraventricular TachycardiaPSVTNCT05820035
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
A study testing Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter in people with Paroxysmal Supraventricular Tachycardia and Atrioventricular Nodal Reentrant Tachycardia, run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia, Atrioventricular Reciprocating Tachycardia
- What is being tested?
- Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2023to 9 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 80 years,
- episode of PSVT recorded by a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, or esophageal electrophysiologic study (EES) before hospitalization
- reproducible clinical tachycardia confirmed by the electrophysiological study (EPS).
Who cannot join
- Previous failure or recurrence of radiofrequency ablation
- Left ventricular ejection fraction (LVEF) ≤ 40%
- Combined with atrial flutter or atrial fibrillation
- Combination of thromboembolic disease
- Women who are breastfeeding, pregnant or planning to become pregnant during the study period
- Carrying active implants in the body (e.g., pacemakers, ICDs, etc.)
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- Patients with second-degree (type II) or third-degree atrioventricular block
- NYHA Class III-IV cardiac function [Appendix 1]
- Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale)
- Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month
- cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
- Acute or severe systemic infection
- Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases
- Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders
- Patients who have participated or are participating in other clinical trials within 3 months before enrollment
- Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Ningbo University (original name :Ningbo First Hospital)
Ningbo, Zhejiang, 315000
About this study
Official title: Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China
The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter
Read the detailed description
The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs . The primary safety endpoints were to assess the incidences of serious adverse events (SAEs) at the end of the procedure , discharge and during the 6-month follow-up period.
- Conditions
- Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia, Atrioventricular Reciprocating Tachycardia
- Being tested
- Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter
- Keywords
- PFA, PSVT, AVNRT, AVRT
- Medical subject headings
- Tachycardia, Ventricular, Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation CatheterDevice
All subjects will be ablated using the pulsed field ablation device and CF-sensing pulsed field ablation catheter in the management of their paroxysmal supraventricular tachycardia
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | Patients of PSVT treated with PFA catheter. Receives: Device: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy and safety endpoints
The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs. The primary safety endpoints were to assess the incidences of SAEs at the end of the procedure and during the 6-month follow-up period.
Measured: at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary outcomes (1)
Interim analysis
To assess immediate ablation ablation success at 6 months postoperatively, by Holter in single center.
Measured: Refers to the postoperative phase after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start9 Mar 2023
- Primary completion23 Feb 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Supraventricular TachycardiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, single-arm study
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820035
- Sponsor's protocol ID
- 775044
- Acronym
- PSVT
- Status last verified
- May 2025
- First submitted
- 17 Mar 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China
- ClinicalTrials.gov ID
- NCT05820035
- Acronym / sponsor ID
- PSVT / 775044
- Conditions
- Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia, Atrioventricular Reciprocating Tachycardia
- Keywords
- PFA, PSVT, AVNRT, AVRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 19 Apr 2023 (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.
The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter
Detailed description
The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs . The primary safety endpoints were to assess the incidences of serious adverse events (SAEs) at the end of the procedure , discharge and during the 6-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, single-arm study
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Device: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation CatheterPatients of PSVT treated with PFA catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age from 18 to 80 years,
- episode of PSVT recorded by a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, or esophageal electrophysiologic study (EES) before hospitalization
- reproducible clinical tachycardia confirmed by the electrophysiological study (EPS).
Key exclusion criteria (16 listed)
- Previous failure or recurrence of radiofrequency ablation
- Left ventricular ejection fraction (LVEF) ≤ 40%
- Combined with atrial flutter or atrial fibrillation
- Combination of thromboembolic disease
- Women who are breastfeeding, pregnant or planning to become pregnant during the study period
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 |
|---|---|---|
| Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation CatheterAll subjects will be ablated using the pulsed field ablation device and CF-sensing pulsed field ablation catheter in the management of their paroxysmal supraventricular tachycardia | Device | Experiment group |
Primary outcome
Primary efficacy and safety endpoints
Time frame: at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up
The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs. The primary safety endpoints were to assess the incidences of SAEs at the end of the procedure and during the 6-month follow-up period.
1 secondary outcome
Interim analysis
Time frame: Refers to the postoperative phase after 6 months.
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 28 May 2025.
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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 Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter in people with Paroxysmal Supraventricular Tachycardia and Atrioventricular Nodal Reentrant Tachycardia, run by Shanghai MicroPort EP MedTech Co., Ltd. at 1 site in China.
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 3 inclusion and 16 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 28 May 2025. 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 China. 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?
Primary efficacy and safety endpoints (time frame: at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up). 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 28 May 2025.