Ningbo First Hospital
Hangzhou, China
Location status: Recruiting
NCT Number: NCT07036965
Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.
Interested in participating?
Request Info118 year and older
All sexes
Interventional
Not applicable
Hangzhou, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
abc
bcd
Time frame: 12 months post-procedure
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
Time frame: Immediately post-procedure
Defined as maintained bidirectional block across the ablation line 20 minutes after ablation
Time frame: Within 7 days post-procedure
Including stroke/transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve paralysis, systemic embolism, pericarditis, pericardial effusion/cardiac tamponade, atrioesophageal fistula, myocardial infarction, or severe vascular access complications
Time frame: Within 12 months post-procedure
Summary ncidence of repeat ablation after the blanking period
Time frame: 6 and 12 months post-procedure
Record AF burden at 6 and 12 months post-procedure
Time frame: Within 12 months post-procedure
Incidence of thromboembolic events (including stroke/TIA), cardiovascular-related rehospitalization, or cardiovascular mortality within 12 months post-procedure
Time frame: Immediately post-procedure
Defined as successful LAA occlusion without residual shunt >3 mm and no device-related complications
Time frame: 3 and 6 months post-procedure
Defined as imaging-confirmed residual shunt ≤3 mm at the device edges.
Time frame: 3 and 6 months post-procedure
Defined as any increase in residual shunt (post-procedure shunt volume - intraoperative shunt volume >0 mm)
Time frame: Within 12 months post-procedure.
Record device-related thrombus events during follow-up
Time frame: Within 12 months post-procedure
Record drugs history during follow up
Contact information is provided by the study sponsor or research team.
Hangzhou Dinova EP Technology Co., Ltd
Industry
Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial
Acronym: COMBINATION 2P
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.
Published trials that share one or more normalized conditions with this study.
NCT07298473
Arrhythmias, Cardiac, Atrial Fibrillation
Birmingham, Alabama, United States
View Trial DetailsNCT07738523
Arrhythmias, Cardiac, Atrial Fibrillation
Getafe, Madrid, Spain
View Trial DetailsNCT07728539
Acute Cerebrovascular Accident, Arrhythmias, Cardiac
Moscow, Russia
View Trial DetailsNCT07726056
Arrhythmias, Cardiac, Atrial Fibrillation
Melbourne, Australia
View Trial Details