Atrial Fibrillation, Heart Diseases
Conditions
Brief summary
This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups.
Interventions
DEVICEAThrough radiofrequency transseptal puncture system
Utilizing AThrough radiofrequency transseptal puncture system for left atrial access
DEVICETraditional mechanical transseptal puncture needle
Utilizing Traditional mechanical transseptal puncture needle for left atrial access
Sponsors
Hangzhou NOYA MedTech Co. Ltm.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient age ≥ 18 years; 2. Subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route; 3. Subjects have been informed about the nature of the study, understand the purpose of the clinical trial, and voluntarily participate and sign the informed consent form.
Exclusion criteria
1. Echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma; 2. Subjects with an atrial septal defect occluder or atrial septal patch implant; 3. Hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment; 4. Acute myocardial infarction occurred within the last 4 weeks; 5. End-stage heart failure (ACC/AHA stage D); post-heart transplant; or awaiting heart transplant; 6. Pregnant or breastfeeding women; 7. Acute systemic infection or sepsis; 8. Participation in any drug and/or medical device clinical trial within the last month; 9. Researchers judge the patient's compliance to be poor, unable to complete the study as required; or other situations deemed by the researchers as making the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transseptal puncture success rate. | Intraprocedural assessment | Defined as successfully completing the puncture in the atrial septum and establishing a pathway from the right atrium to the left atrium (with the sheath entering the left atrium) using the transseptal puncture system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial transseptal puncture success rate. | Intraprocedural assessment | Defined as the period from the introduction of the transseptal puncture system into the femoral vein to the entry of transseptal sheath into the left atrium. |
| Time required to successfully complete the transseptal puncture. | Intraprocedural assessment | Defined as the time from when the transseptal puncture system is introduced into the femoral vein to when the transseptal sheath enters the left atrium. |
| Number of attempts needed to successfully complete the transseptal puncture. | Intraprocedural assessment | During the transseptal puncture process, if the transseptal puncture system needs to be readjusted upwards and repositioned for oval fossa puncture, each readjustment should count as an additional attempt. |
| Ratio of atrial septal puncture failures that cross over to the opposite group. | Intraprocedural assessment | Ratio of atrial septal puncture failures that cross over to the opposite group; |
Countries
China
Outcome results
None listed