Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems (MICROPFA)
Cerebral Microembolization During Pulmonary Vein Isolation: a Randomized Comparison of Different Pulsed Field Ablation Systems
연구 개요
상태
정황
상세 설명
This study is designed as a prospective, randomized, parallel-group interventional trial conducted at Clinical Hospital Dubrava, Zagreb, Croatia and University Hospital Center Sisters of Charity, Zagreb, Croatia. The study will include adult patients with paroxysmal or persistent atrial fibrillation who have a clinical indication for catheter ablation with pulmonary vein isolation.
Eligible patients will be randomized using a computer-generated randomization sequence to undergo pulmonary vein isolation with one of the following pulsed field ablation systems: PulseSelect, Varipulse, Farapulse, Sphere-9, or Sphere-360. All procedures will be performed according to standard clinical practice, with continuous periprocedural anticoagulation in accordance with current guidelines.
Cerebral microembolization will be assessed using transcranial Doppler. The examination will be performed immediately before the ablation procedure and repeated after the procedure. The presence and number of microembolic signals will be recorded. This will allow assessment of changes in microembolic signal burden within each group and comparison of these changes between different pulsed field ablation systems.
Demographic, clinical, and procedural data will be collected, including age, sex, type of atrial fibrillation, comorbidities, procedure duration, number of ablation applications, and procedural complications. The study will also record procedure-related clinical neurological events.
The primary outcome will be the difference in the change in the number of microembolic signals before and after the procedure, expressed as ΔMES, between the different pulsed field ablation systems. Secondary outcomes will include within-group changes in microembolic signal burden, incidence of new microembolic signals after the procedure, association between procedural parameters and ΔMES, and occurrence of procedure-related neurological events.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ivan Zeljković, PhD,MD
- 전화번호: +385917823289
- 이메일: ivanzeljkov@gmail.com
연구 연락처 백업
- 이름: Mihovil Santini, MD
- 전화번호: +385958101778
- 이메일: 023miho@gmail.com
연구 장소
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Zagreb, 크로아티아, 10000
- UH Dubrava
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수석 연구원:
- Ivan Zeljković, MD, Phd
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부수사관:
- Mihovil Santini, MD
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Zagreb, 크로아티아, 10000
- University Hospital Center Sisters of Charity, Zagreb, Croatia
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 years or older
- Paroxysmal or persistent atrial fibrillation
- Indication for catheter ablation with pulmonary vein isolation
- Feasibility of transcranial Doppler assessment
- Signed informed consent
Exclusion Criteria:
- Recent stroke or transient ischemic attack
- Significant cerebrovascular disease preventing reliable transcranial Doppler assessment
- Severe valvular or structural heart disease
- Pregnancy or breastfeeding
- Inability to receive anticoagulation
공부 계획
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 |
|---|---|
|
활성 비교기: PulseSelect PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the PulseSelect pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
Pulmonary vein isolation will be performed using the PulseSelect pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
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활성 비교기: Varipulse PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Varipulse pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
Pulmonary vein isolation will be performed using the Varipulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
|
활성 비교기: Farapulse PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Farapulse pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
Pulmonary vein isolation will be performed using the Farapulse pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedu
|
|
활성 비교기: Sphere-9 PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-9 pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
Pulmonary vein isolation will be performed using the Sphere-9 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure.
|
|
활성 비교기: Sphere-360 PFA
Participants randomized to this arm will undergo clinically indicated pulmonary vein isolation using the Sphere-360 pulsed field ablation system.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure
|
Pulmonary vein isolation will be performed using the Sphere-360 pulsed field ablation system in patients with paroxysmal or persistent atrial fibrillation undergoing clinically indicated catheter ablation.
Cerebral microembolic signals will be assessed by transcranial Doppler before and after the procedure
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in microembolic signal burden after pulmonary vein isolation
기간: During procedure
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Difference in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation, expressed as ΔMES, compared between the different pulsed field ablation systems.
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During procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Within-group change in microembolic signal burden
기간: During procedure
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Change in the number of cerebral microembolic signals detected by transcranial Doppler before and after pulmonary vein isolation within each pulsed field ablation system group.
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During procedure
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Incidence of new microembolic signals after ablation
기간: Immediately after the ablation procedure
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Proportion of participants with newly detected cerebral microembolic signals on transcranial Doppler after pulmonary vein isolation.
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Immediately after the ablation procedure
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Procedure-related clinical neurological events
기간: From the start of the ablation procedure through 72 hours after the procedure
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Occurrence of clinically evident neurological events related to the ablation procedure, including stroke or transient ischemic attack.
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From the start of the ablation procedure through 72 hours after the procedure
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Association between procedure duration and ΔMES
기간: During procedure
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Association between total procedure duration and the change in cerebral microembolic signal burden before and after pulmonary vein isolation.
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During procedure
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Association between number of ablation applications and ΔMES
기간: During procedure
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Association between the number of pulsed field ablation applications delivered during pulmonary vein isolation and the change in cerebral microembolic signal burden before and after the procedure.
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During procedure
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026/0423-11
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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