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NCT Number: NCT06573853

Outcomes of PFA Vs. RFA for Patients with PSVT: 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.

1. Recieved PFA or RFA 1 year ago 2. Finish the visit to the clinic at 1, 3, 6, 12 months for examinations and blood testings 3. Patients recieved PFA and PFA under propensity matched comparison according to differen variety of PSVT

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Key information

Conditions

Paroxysmal Supraventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Location status: Recruiting

Location contact

Chu HuiMin

CONTACT

[email protected]

0574-87085588

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Focal Pulsed Field Ablation (PFA)

Procedure

Patients in the PFA group underwent ablation procedures utilizing a force-sensing PFA catheter for the treatment of PSVT.

Focal Radiofrequecy Ablation (RFA)

Procedure

Patients in the PFA group underwent ablation procedures utilizing force-sensing RFA catheters for the treatment of PSVT.

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. Non-serious adverse events

    Time frame: 24 hours post ablation for intraoperative serious adverse events and 1 year for follow-up 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caijie Shen, MD,PhD

CONTACT

[email protected]

8615258258126

Sponsors and collaborators

Lead sponsor

Caijie Shen

Other

Collaborators

  • Shanghai MicroPort EP MedTech Co., Ltd.

Registry information

Official study 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

Acronym: PFA*RFA*PSVT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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