An interventional study of superior vena cava isolation and Abnormal left atrial substrate in Persistent Atrial Fibrillation, sponsored by Hangzhou Dinova EP Technology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Hangzhou Dinova EP Technology Co., Ltd · Not applicable, Interventional, and Treatment
This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.
No other detailed description.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 350 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hangzhou Dinova EP Technology Co., Ltd is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation and left atrial posterior wall isolation will be conducted in the experimental group.
Procedure: superior vena cava isolation
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava and left atrial posterior wall isolation will be carried out in the control group.
Procedure: superior vena cava isolation · Procedure: Abnormal left atrial substrate
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group.
12-month atrial fibrillation (AF) ablation success rate
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: 12 months post-procedure
Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage \< 0.1 mV). Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block).
Time frame: Immediately post-procedure
Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage \< 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing.
Time frame: Immediately post-procedure
Procedure-related time
Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.
Time frame: Immediately post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)
Early recurrence rate of atrial arrhythmia (within the blanking period)
Time frame: Within 3 months post-procedure
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period
Time frame: Within 12 months post-procedure
Incidence of repeat ablation after the blanking period
Incidence of repeat ablation after the blanking period
Time frame: Within 12 months post-procedure
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
Time frame: Within 12 months post-fist procedure.
Improvement in Atrial fibrillation burden.
Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography.
Time frame: 3、6 and 12 months post-procedure.
Cardiac function assessment by NYHA
Cardiac function was assessed relative to baseline using the NYHA classification.
Time frame: within 12 months post-procedure
The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.
Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score.
Time frame: Within 12 months post-procedure
Plan to share: No
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Hangzhou Dinova EP Technology Co., Ltd