Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation (SAVE-AF)
2026년 7월 23일 업데이트: Qiang Hu
Efficacy and Safety of Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation by Pulsed Field Ablation for Treatment of Atrial Fibrillation
Atrial fibrillation (AF) is one of the most concerning diseases in the field of cardiac arrhythmias.
It is a type of rapid supraventricular arrhythmia characterized by rapid and disorganized contraction of the atria, which leads to ventricular rate disturbance, impaired cardiac function, and an increased risk of atrial mural thrombus formation.
AF severely reduces patients' quality of life and can cause complications such as heart failure, stroke, and sudden death.
Currently, the vast majority of AF episodes are triggered by pulmonary vein (PV) ectopic foci.
Therefore, catheter ablation is the preferred treatment strategy, with pulmonary vein isolation (PVI) being the cornerstone procedure.
However, a small proportion of patients may have non-PV triggers, particularly originating from the superior vena cava (SVC).
Conventional radiofrequency ablation (RFA) for SVC isolation carries unpredictable risks, including damage to the sinus node and the phrenic nerve.
Therefore, this study aims to investigate the impact of empirical SVC electrical isolation in addition to PVI on the success rate of AF ablation, using pulsed field ablation (PFA)-a non-thermal ablation modality with tissue selectivity and a favorable safety profile.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Qiang Hu, Doctor
- 전화번호: +8602886590223
- 이메일: huqiang071@foxmail.com
연구 장소
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Sichuan
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Chengdu, Sichuan, 중국, 610000
- 모병
- Qiang Hu
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연락하다:
- Qiang Hu, Doctor
- 전화번호: +8602886590223
- 이메일: huqiang071@foxmail.com
-
-
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
아니
설명
Inclusion Criteria:
- Age ≥ 18 years;
- Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months;
- Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China;
- Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy;
- Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.
Exclusion Criteria:
- Prior surgical or catheter ablation for any type of cardiac arrhythmia;
- AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
- Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
- Sinus node dysfunction or other indications for permanent pacemaker implantation;
- Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
- Left atrial anteroposterior diameter ≥ 50 mm;
- Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure;
- Serum creatinine > 2 times the upper limit of normal, or currently on dialysis;
- History of prior cardiothoracic surgery;
- History of permanent pacemaker implantation;
- History of malignancy;
- Long-term use of a central venous catheter;
- Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
- History of allergy to contrast;
- Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period;
- Subjects or their legally authorized representatives who are unwilling to provide written informed consent;
- Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits;
- Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: superior vena cava isolation plus pulmonary vein isolation
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Eligible patients with atrial fibrillation who are randomized to the experimental group will undergo superior vena cava (SVC) electrical isolation in addition to pulmonary vein isolation (PVI) during the pulsed field ablation procedure
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활성 비교기: pulmonary vein isolation
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Eligible patients with atrial fibrillation who are randomized to the control group will undergo pulmonary vein isolation (PVI) during the pulsed field ablation procedure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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the success rate of atrial fibrillation ablation
기간: at 3 month
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it is assessed by 7-day Holter monitoring
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at 3 month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
the success rate of atrial fibrillation ablation
기간: at 6 month and 12 month
|
it is assessed by 7-day Holter monitoring
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at 6 month and 12 month
|
|
left ventricular end-systolic diameter
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
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at 3 month, 6 month and 12 month
|
|
left ventricular end-diastolic diameter
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
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at 3 month, 6 month and 12 month
|
|
left ventricular posterior wall thickness
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
interventricular septal thickness
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular ejection fraction
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
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at 3 month, 6 month and 12 month
|
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E/A
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/e'
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
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at 3 month, 6 month and 12 month
|
|
left atrial volume index
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
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at 3 month, 6 month and 12 month
|
|
left atrial anteroposterior diameter
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
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at 3 month, 6 month and 12 month
|
|
left atrial strain
기간: at 3 month, 6 month and 12 month
|
it is measured by echocardiography
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at 3 month, 6 month and 12 month
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New York Heart Association class
기간: at 3 month, 6 month and 12 month
|
The NYHA is measured by Classification of NYHA heart function
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at 3 month, 6 month and 12 month
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Major adverse events
기간: at 3 month, 6 month and 12 month
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Major adverse events is a composite endpoint of death, stroke, and myocardial infarction.
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at 3 month, 6 month and 12 month
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|
6-min walk distance
기간: at 3 month, 6 month and 12 month
|
During the test, patients were asked to walk for 6 minutes on a long corridor with a length of 37.5 meters between the 2 marks
|
at 3 month, 6 month and 12 month
|
|
red blood cell count
기간: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
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hemoglobin
기간: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
white blood cell count
기간: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
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platelet count
기간: at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
alanine aminotransferase
기간: at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
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at 3 month, 6 month and 12 month
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aspartate aminotransferase
기간: at 3 month, 6 month and 12 month
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It is obtained from the liver function test.
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at 3 month, 6 month and 12 month
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creatinine
기간: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
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at 3 month, 6 month and 12 month
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urea
기간: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
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at 3 month, 6 month and 12 month
|
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estimated glomerular filtration rate
기간: at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
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activated partial thromboplastin time
기간: at 3 month, 6 month and 12 month
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It is obtained from the coagulation function test
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at 3 month, 6 month and 12 month
|
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prothrombin time
기간: at 3 month, 6 month and 12 month
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It is obtained from the coagulation function test
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at 3 month, 6 month and 12 month
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international normalized ratio
기간: at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
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at 3 month, 6 month and 12 month
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B-type natriuretic peptide
기간: at 3 month, 6 month and 12 month
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It is obtained from a blood sample.
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at 3 month, 6 month and 12 month
|
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Atrial Fibrillation Effect on Quality of Life Questionnaire
기간: at 3 month, 6 month and 12 month
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AFEQT questionnaire was used to assess the quality of life of patients with atrial fibrillation.
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at 3 month, 6 month and 12 month
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readmission
기간: at 3 month, 6 month and 12 month
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Rehospitalization was indicated for atrial fibrillation.
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at 3 month, 6 month and 12 month
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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 (실제)
2026년 7월 20일
기본 완료 (추정된)
2029년 3월 31일
연구 완료 (추정된)
2029년 3월 31일
연구 등록 날짜
최초 제출
2026년 7월 21일
QC 기준을 충족하는 최초 제출
2026년 7월 21일
처음 게시됨 (실제)
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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