A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.
2026년 5월 12일 업데이트: Hangzhou Dinova EP Technology Co., Ltd
Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.
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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
No other detailed description.
연구 유형
중재적
등록 (추정된)
350
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: GUODONG NIU
- 전화번호: +86 0871-68279999
- 이메일: guodniu@163.com
연구 장소
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Yunnan
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Kunming, Yunnan, 중국
- Fuwai Yunnan Hospital
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연락하다:
- Guodong Niu, PhD
- 전화번호: +860871-68279999
- 이메일: guodniu@163.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Older than 18 years.
- Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days.
- Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Exclusion Criteria:
- Atrial fibrillation is secondary to thyroid disease or other reversible factors.
- Evidence of left atrial or left atrial appendage thrombus on imaging examination.
- Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
- Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
- Left atrial anteroposterior diameter >55 mm.
- Unstable angina.
- Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
- Previous catheter ablation or surgical ablation for atrial fibrillation.
- History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
- Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
- Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
- Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
- Active systemic infection.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
- Severe hepatic dysfunction.
- Pregnancy or breastfeeding.
- Life expectancy <12 months (e.g., advanced malignancy).
- Current or anticipated participation in other drug or device clinical trials.
- Any other condition or abnormality deemed by the investigator to warrant exclusion.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: superior vena cava isolation
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.
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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.
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활성 비교기: superior vena cava and left atrial posterior wall 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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12 개월의 심방 세동 (AF) 절제 성공률
기간: 시술 후 12 개월
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블랭킹 기간 후 동적 심전도 (ECG) 모니터링 (ECG) 모니터링에서 AF, 심방 플러터 (AFL) 또는 심방 빈맥 (AT) 에피소드의 부재로 정의됩니다 (카테터 후 90 일).
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시술 후 12 개월
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
기간: Immediately post-procedure
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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).
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Immediately post-procedure
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Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
기간: Immediately post-procedure
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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.
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Immediately post-procedure
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Procedure-related time
기간: Immediately post-procedure
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Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.
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Immediately post-procedure
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Early recurrence rate of atrial arrhythmia (within the blanking period)
기간: Within 3 months post-procedure
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Early recurrence rate of atrial arrhythmia (within the blanking period)
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Within 3 months post-procedure
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Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.
기간: Within 12 months post-procedure
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Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period
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Within 12 months post-procedure
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Incidence of repeat ablation after the blanking period
기간: Within 12 months post-procedure
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Incidence of repeat ablation after the blanking period
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Within 12 months post-procedure
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Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
기간: Within 12 months post-fist procedure.
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Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
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Within 12 months post-fist procedure.
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Improvement in Atrial fibrillation burden.
기간: 3、6 and 12 months post-procedure.
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Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography.
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3、6 and 12 months post-procedure.
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Cardiac function assessment by NYHA
기간: within 12 months post-procedure
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Cardiac function was assessed relative to baseline using the NYHA classification.
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within 12 months post-procedure
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The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.
기간: Within 12 months post-procedure
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Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score.
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Within 12 months post-procedure
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 4월 30일
기본 완료 (추정된)
2029년 2월 1일
연구 완료 (추정된)
2029년 2월 1일
연구 등록 날짜
최초 제출
2026년 4월 20일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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