Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrilation:InsightPFA Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmias, Cardiac
- Sponsor
- Insight Medtech Co., Ltd.
- Enrollment
- 292
- Locations
- 10
- Primary Endpoint
- the 12-month treatment success rate
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
Detailed Description
The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 75 years, of either sex.
- •Patients with ECG-confirmed or clinically definite diagnosis of symptomatic paroxysmal atrial fibrillation (PAF).
- •Scheduled to undergo catheter ablation for atrial fibrillation
- •Willing to participate in this clinical trial, voluntarily sign the informed consent form, and commit to completing required examinations and follow-ups per protocol..
Exclusion Criteria
- •History of prior surgery or catheter ablation for atrial fibrillation (AF);
- •Clinical diagnosis of persistent or long-standing persistent AF;
- •Left ventricular ejection fraction (LVEF) \< 40% or New York Heart Association (NYHA) functional class III or IV;
- •Left atrial diameter (as measured by echocardiography) ≥ 50 mm;
- •Imaging findings suggestive of left atrial or left atrial appendage thrombus;
- •Contraindications to anticoagulation therapy, including a history of blood clotting disorders or abnormal bleeding;
- •Presence of acute or active systemic infection;
- •Significant lung disease, pulmonary hypertension, or any lung condition associated with severe dyspnea, such as abnormal blood gases;
- •Clinical diagnosis of hypertrophic cardiomyopatly, chronic obstructive pulmonary disease (COPD), or known/suspected atrial myxoma;
- •History of previous heart valve repair or replacement, implantation of a prosthetic valve, or previous cardiac interventions such as atrial septal defect closure or patent foramen ovale closure;
Outcomes
Primary Outcomes
the 12-month treatment success rate
Time Frame: during the 12-month follow-up period after a 90-day blank period.
12month treatment success, is defined as freedom from any episodes of AF/atrial flutter (AFL)/atrial tachycardia (AT) without the use of Class I or III antiarrhythmic drugs (AADs) during the 12-month follow-up period after a 90-day blank period. An electrocardiogram or 24 h Holter monitoring should be performed to confirm all episodes. The occurrence of AF/AFL/AT during a blank period is not considered a treatment failure and can be treated with AADs (other than amiodarone), electric cardioversion, or only a time of catheter ablation procedure (the devices used during the redo procedure should be the same as those used in the original procedure). After the blanking period, any documentation of AF, AFL, or AT ≥ 30 s is considered a failure concerning the primary effectiveness endpoint. Following the blanking period, any use of a Class I or III AAD constitutes a treatment failure.
Secondary Outcomes
- Total left atrium indwelling time(During the procedure)
- Total abaltion time(During the procedure)
- Total X-ray exposure time(During the procedure)
- Total X-ray exposure dose(During the procedure)
- Number of participants under general anesthesia(During the procedure)
- incidence of surgical complications(12 months after the ablation)
- Acute procedural success(after a 20 min observation period following the last ablation.)
- Total procedure time(During the procedure)
- Evaluation of the ablation system（questionnaire）(immediately post ablation)
- Evaluation of the ablation catheter（questionnaire）(immediately post ablation)
- Evaluation of the adjustable introducer sheath set（questionnaire）(immediately post ablation)
- incidence of composite safety endpoint(12 months after the ablation)
- Incidence of severe adverse events(12 months after the ablation)
- Incidence of device-related adverse events(12 months after the ablation)