Paroxysmal Supraventricular TachycardiaPFA*RFA*PSVTNCT06573853
Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study
An observational study of Paroxysmal Supraventricular Tachycardia and Catheter Ablation, run by Caijie Shen at 1 site in China.
Trial summary
The goal of this retrospective study is to compare the long-term follow-up outcomes of pulses field ablation (PFA) Vs. radiofrequency ablation (RFA) for the patients with paroxysmal supraventricular tachycardia (PSVT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia, Catheter Ablation
- What is being tested?
- Focal Pulsed Field Ablation (PFA) and Focal Radiofrequecy Ablation (RFA)
- Type of treatment
- Surgery or procedure
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2022to 30 Jun 2025
- Phase
- Observational
- 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
Study population: PSVT was documented with a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, and esophageal electrophysiologic study (EES) before hospitalization. A diagnosis of AVNRT or AVRT was confirmed by electrophysiological study after the antiarrhythmic medications were withdrawn ≥5 half-lives. Patients with reproducibly clinical PSVT were finally enrolled.
Who may be able to join
- Patients with symptomatic PSVT including: atrioventricular nodal re-entrant tachycardia (AVNRT), atrioventricular re-entrant tachycardia (AVRT);
- Age range: 18 years old ≤ age ≤ 80 years old, with no gender restriction;
- Willing to receive the examinations and testings during one year follow-up required by the protocol;
- Voluntary signed informed consent.
Who cannot join
- Organic heart disease;
- History of cardiac surgery;
- Previous failed ablation of PSVT;
- Presence of any implants, such as a permanent pacemaker;
- Patients with invasive systemic infections or advanced malignant tumors;
- Contraindications for septal puncture or retrograde transaortic access surgery;
Show all 10Show fewer
- Any condition that makes the use of heparin or aspirin inappropriate;
- Pregnant or lactating women;
- Inability to fully comply with the study procedures and follow-ups or to provide their own informed consent;
- Coexistence with other arrhythmias, such as atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Chu HuiMin, 0574-87085588, markchu@126.com
About this study
Official title: The Safety and Efficiency of Pulsed Field Ablation and Radiofrequency Ablation in the Treatment of Paroxysmal Supraventricular Tachycardia：a Retrospective and Propensity Score Matching Study
The goal of this retrospective study is to compare the long-term follow-up outcomes of pulses field ablation (PFA) Vs. radiofrequency ablation (RFA) for the patients with paroxysmal supraventricular tachycardia (PSVT). The main question to answer is:
Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.
- Recieved PFA or RFA 1 year ago
- Finish the visit to the clinic at 1, 3, 6, 12 months for examinations and blood testings
- Patients recieved PFA and PFA under propensity matched comparison according to differen variety of PSVT
Read the detailed description
The goal of this retrospective study is to compare the long-term follow-up outcomes of PFA Vs. RFA for the patients with PSVT. The main question to answer is:
Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.
- Being tested
- Focal Pulsed Field Ablation (PFA), Focal Radiofrequecy Ablation (RFA)
- Keywords
- Paroxysmal Supraventricular Tachycardia, Pulsed Field Ablation, Radiofrequency Ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Pulsed Field Ablation (PFA)Procedure or surgery
Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT.
Focal Radiofrequecy Ablation (RFA)Procedure or surgery
Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.
| Study group | Role | What they receive |
|---|---|---|
| PFA group | A retrospective analysis was conducted on 214 patients with PSVT recieving PFA who met the inclusion and exclusion criteria and visited at the First Affiliated Hospital of Ningbo University, the Third People's Hospital of Chengdu, the Xiamen Cardiovascular Hospital of Xiamen University, the First Hospital of Jilin University, the Seventh People's Hospital of Zhengzhou, Shanghai General Hospital, and Jiangxi Provincial People's Hospital from October 2022 to June 2024. These patients were included in the PFA group. Basic clinical information, procedural data, and the efficiency and safety post 1-year follow-up were collected and analyzed. Receives: Procedure: Focal Pulsed Field Ablation (PFA) | |
| RFA group | A retrospective analysis for control group was conducted on patients with PSVT reciecing RFA who met the inclusion and exclusion criteria and visited at the First Affiliated Hospital of Ningbo University the Third People's Hospital of Chengdu, the Xiamen Cardiovascular Hospital of Xiamen University, the First Hospital of Jilin University, the Seventh People's Hospital of Zhengzhou, Shanghai General Hospital, and Jiangxi Provincial People's Hospital from October 2022 to June 2024. 214 patients approached by RFA were matched 1:1 by propensity score to a similar population treated by PFA. Basic clinical information, procedural data, as well as the efficiency and safety of 1-year follow-up were collected and analyzed. Receives: Procedure: Focal Radiofrequecy Ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and long-term follow-up success rate
The Primary endpoints for efficacy included the number of subjects with acute and long-term follow-up success post ablation. The acute success was confirmed by noninducibility of clinical PSVT after programmed stimuli and drug administration after15 minutes waiting time. The long-term follow-up success was defined as the absence of clinical PSVT during the 1-year follow-up.
The acute success is confirmed by catheter mapping and ECG to determine immediate ablation success rate
Measured: 15 minutes post ablation for acute sussess and one year for follow-up success
Incidence of intraoperative and long-term serious adverse events
The Primary endpoints for safety included the number of subjects suffering from serious adverse events. The incidence of serious adverse events related to the ablation included conduction system impairment, ventricular arrhythmia, myocardial infarction, hemolysis or major bleeding requiring transfusion, cardiac tamponade/perforation, Pericarditis requiring treatment, infectious endocarditis, valve stenosis or regurgitation deterioration, heart failure, abnormal renal and/or hepatic function, Intracerebral hemorrhage/transient ischemic attack/ stroke, and death. (Abnormal renal function (dialysis, transplant, serum creatinine >200 mmol/L); Abnormal hepatic function (cirrhosis, bilirubin > x 2 upper limit of normal, aspartate aminotransferase/alkaline phosphatase/alanine aminotransferase >3 x upper limit of normal).
Measured: 24 hours post ablation for intraoperative serious adverse events and one year for follow-up serious adverse events
Secondary outcomes (1)
Non-serious adverse events
Muscle constraction delaying the procedure, untolerable pain or cough, abnormal renal function (without dialysisserum, creatinine <200 mmol/L), and abnormal hepatic function (cirrhosis, bilirubin < x 2 upper limit of normal, aspartate aminotransferase/alkaline phosphatase/alanine aminotransferase <3 x upper limit of normal.
Measured: 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start11 Oct 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caijie Shen
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai MicroPort EP MedTech Co., Ltd.
- Responsible party
- Sponsor-investigator, Caijie Shen, Ningbo No. 1 Hospital
- Investigators
- Caijie Shen, Study director, First Affiliated Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573853
- Sponsor's protocol ID
- 775050
- Acronym
- PFA*RFA*PSVT
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen C, Jia Z, Yu Y, Feng M, Du X, Fu G, Yu L, Wu T, Jiang Y, Jin H, Zhuo W, Gao F, Wang B, Chen S, Dai J, Fang R, Chu H. Efficacy and safety of pulsed field ablation for accessory pathways: a pilot study. Europace. 2024 Jul 2;26(7):euae139. doi: 10.1093/europace/euae139.
PubMed 38801673Shen 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficiency of Pulsed Field Ablation and Radiofrequency Ablation in the Treatment of Paroxysmal Supraventricular Tachycardia：a Retrospective and Propensity Score Matching Study
- ClinicalTrials.gov ID
- NCT06573853
- Acronym / sponsor ID
- PFA*RFA*PSVT / 775050
- Keywords
- Paroxysmal Supraventricular Tachycardia, Pulsed Field Ablation, Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Caijie ShenUniversity, hospital or other
- Collaborators
- Shanghai MicroPort EP MedTech Co., Ltd.
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Aug 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.
The goal of this retrospective study is to compare the long-term follow-up outcomes of pulses field ablation (PFA) Vs. radiofrequency ablation (RFA) for the patients with paroxysmal supraventricular tachycardia (PSVT). The main question to answer is:
Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.
- Recieved PFA or RFA 1 year ago
- Finish the visit to the clinic at 1, 3, 6, 12 months for examinations and blood testings
- Patients recieved PFA and PFA under propensity matched comparison according to differen variety of PSVT
Detailed description
The goal of this retrospective study is to compare the long-term follow-up outcomes of PFA Vs. RFA for the patients with PSVT. The main question to answer is:
Does the PFA was more effecient and safer that RFA for treatment of PSVT during procedure and after 1-year follow-up? Researchers will compare the acute and long-term efficiency and safety between PFA and RFA.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFA group | – | Procedure: Focal Pulsed Field Ablation (PFA)A retrospective analysis was conducted on 214 patients with PSVT recieving PFA who met the inclusion and exclusion criteria and visited at the First Affiliated Hospital of Ningbo University, the Third People's Hospital of Chengdu, the Xiamen Cardiovascular Hospital of Xiamen University, the First Hospital of Jilin University, the Seventh People's Hospital of Zhengzhou, Shanghai General Hospital, and Jiangxi Provincial People's Hospital from October 2022 to June 2024. These patients were included in the PFA group. Basic clinical information, procedural data, and the efficiency and safety post 1-year follow-up were collected and analyzed. |
| RFA group | – | Procedure: Focal Radiofrequecy Ablation (RFA)A retrospective analysis for control group was conducted on patients with PSVT reciecing RFA who met the inclusion and exclusion criteria and visited at the First Affiliated Hospital of Ningbo University the Third People's Hospital of Chengdu, the Xiamen Cardiovascular Hospital of Xiamen University, the First Hospital of Jilin University, the Seventh People's Hospital of Zhengzhou, Shanghai General Hospital, and Jiangxi Provincial People's Hospital from October 2022 to June 2024. 214 patients approached by RFA were matched 1:1 by propensity score to a similar population treated by PFA. Basic clinical information, procedural data, as well as the efficiency and safety of 1-year follow-up were collected and analyzed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PSVT was documented with a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, and esophageal electrophysiologic study (EES) before hospitalization. A diagnosis of AVNRT or AVRT was confirmed by electrophysiological study after the antiarrhythmic medications were withdrawn ≥5 half-lives. Patients with reproducibly clinical PSVT were finally enrolled.
Key inclusion criteria (4 listed)
- Patients with symptomatic PSVT including: atrioventricular nodal re-entrant tachycardia (AVNRT), atrioventricular re-entrant tachycardia (AVRT);
- Age range: 18 years old ≤ age ≤ 80 years old, with no gender restriction;
- Willing to receive the examinations and testings during one year follow-up required by the protocol;
- Voluntary signed informed consent.
Key exclusion criteria (10 listed)
- Organic heart disease;
- History of cardiac surgery;
- Previous failed ablation of PSVT;
- Presence of any implants, such as a permanent pacemaker;
- Patients with invasive systemic infections or advanced malignant tumors;
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 |
|---|---|---|
| Focal Pulsed Field Ablation (PFA)Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT. | Procedure or surgery | PFA group |
| Focal Radiofrequecy Ablation (RFA)Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT. | Procedure or surgery | RFA group |
Primary outcome
Acute and long-term follow-up success rate
Time frame: 15 minutes post ablation for acute sussess and one year for follow-up success
The Primary endpoints for efficacy included the number of subjects with acute and long-term follow-up success post ablation. The acute success was confirmed by noninducibility of clinical PSVT after programmed stimuli and drug administration after15 minutes waiting time. The long-term follow-up success was defined as the absence of clinical PSVT during the 1-year follow-up. The acute success is confirmed by catheter mapping and ECG to determine immediate ablation success rate
Incidence of intraoperative and long-term serious adverse events
Time frame: 24 hours post ablation for intraoperative serious adverse events and one year for follow-up serious adverse events
The Primary endpoints for safety included the number of subjects suffering from serious adverse events. The incidence of serious adverse events related to the ablation included conduction system impairment, ventricular arrhythmia, myocardial infarction, hemolysis or major bleeding requiring transfusion, cardiac tamponade/perforation, Pericarditis requiring treatment, infectious endocarditis, valve stenosis or regurgitation deterioration, heart failure, abnormal renal and/or hepatic function, Intracerebral hemorrhage/transient ischemic attack/ stroke, and death. (Abnormal renal function (dialysis, transplant, serum creatinine >200 mmol/L); Abnormal hepatic function (cirrhosis, bilirubin > x 2 upper limit of normal, aspartate aminotransferase/alkaline phosphatase/alanine aminotransferase >3 x upper limit of normal).
1 secondary outcome
Non-serious adverse events
Time frame: 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up serious adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 38801673Shen C, Jia Z, Yu Y, Feng M, Du X, Fu G, Yu L, Wu T, Jiang Y, Jin H, Zhuo W, Gao F, Wang B, Chen S, Dai J, Fang R, Chu H. Efficacy and safety of pulsed field ablation for accessory pathways: a pilot study. Europace. 2024 Jul 2;26(7):euae139. doi: 10.1093/europace/euae139.
- Background: 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
Related trials for Paroxysmal Supraventricular Tachycardia
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
RecruitingPhase 2
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
Paroxysmal Supraventricular Tachycardia
Recruiting
NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia
Supraventricular Tachycardia, Paroxysmal Supraventricular Tachycardia
Enrolling by invitation
The Best Workflow for Paroxysmal Supraventricular Tachycardia Ablation With Zero-fluoroscopy
Cardio Vascular Disease, Cryoablation
Not yet recruiting
Clinical Study on the Safety and Efficacy of a New Magnetic Navigation Radiofrequency Ablation Catheter for Rapid Arrhythmia
Rapid Arrhythmia, PFA
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.
Caijie Shen study director
First Affiliated Hospital of Ningbo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Supraventricular Tachycardia and Catheter Ablation, run by Caijie Shen 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caijie Shen, MD,PhD (8615258258126, shenzihai1101@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and long-term follow-up success rate (time frame: 15 minutes post ablation for acute sussess and one year for follow-up success). 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 NCT06573853, which also lists 2 linked publications.
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 24 Oct 2024.