Efficacy and safety of pulsed field ablation for accessory pathways: a pilot study.
Caijie Shen, Zhenyu Jia, Yibo Yu...
https://pubmed.ncbi.nlm.nih.gov/38801673Actively Recruiting
Age: 18Years - 80Years
All Genders
ID06573853
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
Led by Caijie Shen · Updated on 2024-10-24
428
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Caijie Shen
Lead Sponsor
S
Shanghai MicroPort EP MedTech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing the long-term results of two procedures, Pulsed Field Ablation (PFA) and Radiofrequency Ablation (RFA), for patients with paroxysmal supraventricular tachycardia (PSVT). This retrospective study aims to find out whether PFA is more efficient and safer than RFA during the procedure and after one year of follow-up. The study includes patients who received either PFA or RFA one year ago and tracks their outcomes over time. The study involves two groups of patients: one treated with PFA using a force-sensing PFA catheter and the other with RFA using force-sensing RFA catheters. Data from 214 patients who received PFA and 214 matched patients who received RFA were collected from multiple hospitals between October 2022 and June 2024. Researchers analyzed clinical information, procedural data, and safety and effectiveness outcomes for one year after treatment. Participants were followed up at 1, 3, 6, and 12 months after their ablation procedures with examinations and blood tests. Researchers measured the success rate shortly after the procedure and at one year, as well as the occurrence of serious and non-serious adverse events during and after the treatments. The study helps to understand the safety and effectiveness of these two ablation methods for PSVT over the long term.
CONDITIONS
Brief Title
Outcomes of PFA Vs. RFA for Patients with PSVT: a Retrospective and Propensity Score Matching Study
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic PSVT including atrioventricular nodal re-entrant tachycardia (AVNRT) and atrioventricular re-entrant tachycardia (AVRT)
- Age between 18 and 80 years, any gender
- Willing to complete examinations and tests during one year of follow-up as required by the study
- Voluntary signed informed consent
You will not qualify if you...
- Presence of organic heart disease
- History of cardiac surgery
- Previous failed ablation of PSVT
- Presence of any implants such as a permanent pacemaker
- Invasive systemic infections or advanced malignant tumors
- Contraindications for septal puncture or retrograde transaortic access surgery
- Conditions that make use of heparin or aspirin inappropriate
- Pregnant or lactating women
- Inability to comply fully with study procedures and follow-ups or to provide informed consent
- Coexistence with other arrhythmias such as atrial fibrillation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants undergo either Pulsed Field Ablation (PFA) or Radiofrequency Ablation (RFA) procedures for the treatment of PSVT.
1 visit (in-person)
Long-term Monitoring
Duration - 1 year
Participants are followed for one year to assess the safety and effectiveness of the ablation procedure including acute and long-term success rates and adverse events.
Follow-up visits as required over 1 year
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
Actively Recruiting
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Research Team
C
Caijie Shen, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Outcomes of Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia.
Caijie Shen, Xianfeng Du, Jiating Dai...
https://pubmed.ncbi.nlm.nih.gov/38242530