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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ivan Zeljković, PhD,MD
- 電話番号：+385917823289
- メール：ivanzeljkov@gmail.com
研究連絡先のバックアップ
- 名前：Mihovil Santini, MD
- 電話番号：+385958101778
- メール：023miho@gmail.com
研究場所
-
-
-
Zagreb、クロアチア、10000
- UH Dubrava
-
主任研究者：
- Ivan Zeljković, MD, Phd
-
副調査官：
- Mihovil Santini, MD
-
Zagreb、クロアチア、10000
- University Hospital Center Sisters of Charity, Zagreb, Croatia
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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
|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in microembolic signal burden after pulmonary vein isolation
時間枠：During procedure
|
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.
|
During procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Within-group change in microembolic signal burden
時間枠：During procedure
|
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.
|
During procedure
|
|
Incidence of new microembolic signals after ablation
時間枠：Immediately after the ablation procedure
|
Proportion of participants with newly detected cerebral microembolic signals on transcranial Doppler after pulmonary vein isolation.
|
Immediately after the ablation procedure
|
|
Procedure-related clinical neurological events
時間枠：From the start of the ablation procedure through 72 hours after the procedure
|
Occurrence of clinically evident neurological events related to the ablation procedure, including stroke or transient ischemic attack.
|
From the start of the ablation procedure through 72 hours after the procedure
|
|
Association between procedure duration and ΔMES
時間枠：During procedure
|
Association between total procedure duration and the change in cerebral microembolic signal burden before and after pulmonary vein isolation.
|
During procedure
|
|
Association between number of ablation applications and ΔMES
時間枠：During procedure
|
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.
|
During procedure
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026/0423-11
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