Paroxysmal Supraventricular TachycardiaNCT05770921
Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia（PSVT）
A study testing Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in people with Paroxysmal Supraventricular Tachycardia, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia
- What is being tested?
- Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2022to 13 Jul 2023
- 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 symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias;
- Willingness to undergo an evaluation to validate the requirements of the protocol.
- Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol.
Who cannot join
- Patients with structural heart disease
- History of any cardiac surgery
- Failure of prior ablation of PSVT
- Presence of any implantation, such as artificial valves, permanent pacemakers, etc
- Patients with active systemic infections
- Any condition contraindicating septal puncture or retrograde transaortic approach for procedures
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- Any condition contraindicating heparin or aspirin
- Patients with advanced malignant tumor
- Any woman known to be pregnant or breastfeeding
- Unwilling or unable to comply fully with study procedures and follow-up
- Unable to provide own informed consent
- Coexistence with other arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter Guided by Columbus 3D EP Navigation System in the Ablation Treatment of Paroxysmal Supraventricular Tachycardia（PSVT）
The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.
Read the detailed description
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following the last index PFA application with the investigational device
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Being tested
- Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter
- Keywords
- PSVT, PFA, AVNRT, AVRT
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation CatheterDevice
All subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia
| Study group | Role | What they receive |
|---|---|---|
| Non-randomized | Experimental | All subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia Receives: Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate ablation success rate
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following by catheter mapping and ECG to determine immediate ablation success rate
Measured: 15 minutes post ablation
Rate of Treatment Success at 6-Month Post-Procedure
Refers to the postoperative phase after 6 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Measured: Refers to the postoperative phase after 6 months postoperatively
Secondary outcomes (4)
Rate of Treatment Success at 1-Month Post-Procedure
Refers to the postoperative phase after 1 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Measured: Refers to the postoperative phase after 1 months postoperatively
Rate of Treatment Success at 2-Month Post-Procedure
Refers to the postoperative phase after 2 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
Measured: Refers to the postoperative phase after 2 months postoperatively
Evaluation of Force Sensing Pulsed Field Ablation Catheter
Evaluation of catheter operation performance;Catheter ablation parameters
Measured: 1 Day of surgery
Evaluation of Pulse Ablation equipment
System software operability; System operation stability; Hardware connection validity
Measured: immediately post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start11 Oct 2022
- Primary completion1 Feb 2023
- Study completion13 Jul 2023
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 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, single-center, single-group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caijie Shen, Ningbo No. 1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770921
- Sponsor's protocol ID
- 775035
- Status last verified
- Dec 2023
- First submitted
- 30 Jan 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen C, Du X, Dai J, Feng M, Yu Y, Liu J, Fu G, Wang B, Jiang Y, Jin H, Chu H. Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia. Can J Cardiol. 2024 Jul;40(7):1294-1303. doi: 10.1016/j.cjca.2023.12.037. Epub 2024 Jan 17.
PubMed 38242530
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter Guided by Columbus 3D EP Navigation System in the Ablation Treatment of Paroxysmal Supraventricular Tachycardia（PSVT）
- ClinicalTrials.gov ID
- NCT05770921
- Acronym / sponsor ID
- 775035
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Keywords
- PSVT, PFA, AVNRT, AVRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 16 Mar 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 a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.
Detailed description
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following the last index PFA application with the investigational device
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single-center, single-group
| Arm | Type | Receives |
|---|---|---|
| Non-randomized | Experimental | Device: Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation CatheterAll subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias;
- Willingness to undergo an evaluation to validate the requirements of the protocol.
- Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol.
Key exclusion criteria (12 listed)
- Patients with structural heart disease
- History of any cardiac surgery
- Failure of prior ablation of PSVT
- Presence of any implantation, such as artificial valves, permanent pacemakers, etc
- Patients with active systemic infections
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 Force Sensing Pulsed Field Ablation CatheterAll subjects will be ablated using the Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the management of their Paroxysmal Supraventricular Tachycardia | Device | Non-randomized |
Primary outcome
Immediate ablation success rate
Time frame: 15 minutes post ablation
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following by catheter mapping and ECG to determine immediate ablation success rate
Rate of Treatment Success at 6-Month Post-Procedure
Time frame: Refers to the postoperative phase after 6 months postoperatively
Refers to the postoperative phase after 6 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
4 secondary outcomes
Rate of Treatment Success at 1-Month Post-Procedure
Time frame: Refers to the postoperative phase after 1 months postoperatively
Rate of Treatment Success at 2-Month Post-Procedure
Time frame: Refers to the postoperative phase after 2 months postoperatively
Evaluation of Force Sensing Pulsed Field Ablation Catheter
Time frame: 1 Day of surgery
Evaluation of Pulse Ablation equipment
Time frame: immediately post ablation
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 3 Jan 2024.
- Derived from this study: PubMed 38242530Shen C, Du X, Dai J, Feng M, Yu Y, Liu J, Fu G, Wang B, Jiang Y, Jin H, Chu H. Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia. Can J Cardiol. 2024 Jul;40(7):1294-1303. doi: 10.1016/j.cjca.2023.12.037. Epub 2024 Jan 17.
- 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 Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in people with Paroxysmal Supraventricular Tachycardia, run by Ningbo No. 1 Hospital 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 12 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 3 Jan 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 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?
Immediate ablation success rate (time frame: 15 minutes post ablation). The study lists 2 primary outcomes in all. 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 NCT05770921, 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 3 Jan 2024.