PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study (PULSE)
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"
調査の概要
詳細な説明
Atrial fibrillation (AF) is a progressive arrhythmia associated with significant morbidity and mortality and burden for our health care system. Early rhythm-control therapy was beneficial regarding cardiovascular outcomes in patients with symptomatic and asymptomatic AF. Recent studies introducing first line Cryo Balloon based catheter ablation EARLY-AF and STOP -AF provided strong evidence supporting early catheter ablation over pharmacologic rhythm control in the paroxysmal setting of AF. Ongoing studies are challenging the current concept investigating the expansion of early rhythm control also to all types of clinically diagnosed AF using cryo ablation. With the advent of pulsed field ablation (PFA), a third energy source-alongside cryothermal and radiofrequency (RF) ablation-has been established for the effective treatment of atrial fibrillation (AF). PFA induces so-called irreversible electroporation, thereby enabling successful ablation of myocardial tissue. Different cell types exhibit varying susceptibility and threshold levels for irreversible electroporation when exposed to PFA. Carefully tailored PFA pulse trains deliver sufficient energy to induce irreversible electroporation while avoiding excessive thermal effects on the surrounding tissue. Consequently, PFA enables selective targeting of myocardial tissue while minimizing collateral injury. This characteristic may translate into improved safety and efficacy in the treatment of AF. In contrast, thermal ablation techniques such as cryoablation and RF ablation inherently rely on substantial temperature changes, either cooling or heating, which may adversely affect adjacent anatomical structures including nerves (e.g., resulting in phrenic nerve palsy), vascular structures, and extracardiac tissues such as the esophagus. The occurrence of these potentially life-threatening complications may be reduced or possibly avoided using PFA. Over recent years, various PFA catheter designs as well as different PFA energy delivery settings have been introduced to enable effective and safe pulmonary vein isolation (PVI). A broad spectrum of catheter configurations-including focal single-tip catheters, pentaspline multielectrode systems, and balloon-based technologies-has been incorporated into clinical practice. Substantial comparative data evaluating PFA against conventional thermal ablation modalities (cryoablation and RF ablation) are now available. To date, no significant differences in acute procedural success rates, procedural parameters, or clinical outcome measures have been consistently observed, although one randomized trial demonstrated a trend toward improved outcomes with PFA. Across these studies, procedure duration was significantly shorter with PFA compared with conventional thermal ablation, representing an additional potential advantage of this treatment modality. More recent studies suggest that catheter ablation-particularly PFA-based ablation-for AF patients without documented recurrence during follow-up may be associated with a reduction in overall ischemic stroke events. These findings indicate that catheter ablation of AF may confer additional benefits in preventing adverse cardiovascular outcomes compared with medical therapy alone. Even in cases of AF recurrence, catheter ablation has been shown not only to significantly reduce AF burden but also to slow the progression from paroxysmal to persistent AF, the latter generally being associated with less favorable clinical outcomes compared with ablation performed during earlier disease stages. Despite the availability of effective antiarrhythmic drug therapy for AF, long-term pharmacological treatment is frequently limited by intolerance, side effects, or insufficient efficacy in a substantial proportion of patients. Nevertheless, large, randomized trials directly comparing PFA-based AF ablation with optimized medical therapy remain scarce.
Therefore, the PULSE study aims to evaluate the impact of PFA using a balloon-based catheter system for the treatment of AF on the maintenance of sinus rhythm compared with optimized medical therapy. In addition, the study will assess AF disease progression in patients with early-stage atrial fibrillation, including both symptomatic and asymptomatic individuals with paroxysmal or early persistent AF.
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：Kathrin Heitmann
- 電話番号：5406 +49 40 181885
- メール：ka.heitmann@asklepios.com
研究連絡先のバックアップ
- 名前：Nele Gessler, MD
- 電話番号：5406 +49 40 181885
- メール：n.gessler@asklepios.com
研究場所
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Bad Oeynhausen、ドイツ
- まだ募集していません
- HZD Bad Oeynhausen
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コンタクト：
- Philipp Sommer, MD
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Cologne、ドイツ
- まだ募集していません
- Uniklinik Köln
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コンタクト：
- Daniel Steven, MD
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Düsseldorf、ドイツ
- まだ募集していません
- Uniklinik Düsseldorf
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コンタクト：
- Obaida Rana, MD
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Frankfurt、ドイツ
- まだ募集していません
- CCB Frankfurt
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コンタクト：
- Melanie Gunawardene, MD
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Giessen、ドイツ
- まだ募集していません
- Uniklinik Gießen
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コンタクト：
- Borislav Dinov, MD
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Hamburg、ドイツ、20099
- 募集
- Arian Sultan
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コンタクト：
- Kathrin Heitmann
- 電話番号：5406 +49 40181885
- メール：ka.heitmann@asklepios.com
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Herne、ドイツ
- まだ募集していません
- Marien Hospital Herne
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コンタクト：
- Christian Ukena, MD
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Leipzig、ドイツ
- まだ募集していません
- Leipzig Herzzentrum HZL
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コンタクト：
- Kerstin Bode, MD
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Neuss、ドイツ
- まだ募集していません
- Lukas Krankenhaus Neuss
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コンタクト：
- Torsten Becker, MD
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Nuremberg、ドイツ
- まだ募集していません
- Klinikum Nürnberg
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コンタクト：
- Thomas Deneke, MD
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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:
- Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation
- First diagnosis of AF within the last 36 months
- At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device
- No prior catheter ablation for AF
Exclusion Criteria:
- Persistent AF >3 years or longstanding persistent AF
- Previous AF-Ablation
- Ongoing continuous AAD therapy with Amiodarone at baseline
- History of failed continuous AAD therapy with > 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy
- Left Atrial Volume Index (LAVI) > 50mL/m2
- Severe mitral regurgitation
- Contraindications to anticoagulation therapy
- Severe pulmonary or renal disease
- Pregnancy, active cancer disease
- Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD)
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Group1: Pulsed Field-Ablation
Patients randomized in the intervention group should receive the PFA ablation within 21 days.
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PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation
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介入なし：Group 2: Usual care
Patients randomized in the control group / usual care group will undergo optimal medical treatment (OMT), defined as antiarrhythmic drug therapy (AAD).
Within 21 days patients in the control group should start or maintain on AAD therapy based on decision of the investigator and according to current ESC Guidelines.
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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 |
|---|---|---|
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Freedom from any Atrial Tachyarrhythmia
時間枠：through 9 weeks to 12 months follow-up
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Arrhythmia-free survival, defined as freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting >30 seconds through 9 weeks to 12 months follow-up on ILR monitoring via blinded core lab or any 12 lead ECG on visits, ECG Holter monitoring, or on symptom driven event monitoring after a 8 week Blanking period (reviewed by a blinded endpoint review committee).
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through 9 weeks to 12 months follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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AF Burden
時間枠：through 9 weeks to 12 months follow-up
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Freedom from atrial fibrillation (AF) (>30 s) through 9 weeks to 12 months follow-up
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through 9 weeks to 12 months follow-up
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Burden of Atrial Tachycardia and Atrial Flutter
時間枠：through 9 weeks to 12 months follow-up
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Freedom from atrial tachycardia and atrial flutter (AFL) (>30 s) through 9 weeks to 12 months follow-up
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through 9 weeks to 12 months follow-up
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Re-hospitalization rate
時間枠：up to 12 months follow-up
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Re-hospitalization rate due to cardiovascular disease (e.g.
AF, worsening of heart failure)
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up to 12 months follow-up
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AF Progression Timeline
時間枠：through 9 weeks to 12 months follow-up
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Progression from paroxysmal to persistent AF trough 9 weeks to 12 months follow-up.
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through 9 weeks to 12 months follow-up
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Symptom Burden assessed by quality of life
時間枠：QoL will be measured at baseline and at 12 months of follow up evaluating the improvement of QoL within one year.
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Symptom Burden, detected by Patient Questionnaires: Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and MOCA. The Montreal Cognitive Assessment (MoCA) is used as screening instrument for cognitive dysfunction. The AFEQT questionnaire is used because it is specific to AF and validated in that subject population. From each AFEQT questionnaire, a single score will be calculated in line with AFEQT scoring guidelines and post-procedure values will be compared between the randomized arms. |
QoL will be measured at baseline and at 12 months of follow up evaluating the improvement of QoL within one year.
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Procedure-related complications
時間枠：up to 12 months follow-up
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Procedure-related complications, including phrenic nerve injury, pulmonary vein stenosis, esophageal injury and stroke.
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up to 12 months follow-up
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HF Progression Markers
時間枠：up to 12 months follow-up
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Progression of heart failure defined as trend in LV-EF and trend in BNP
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up to 12 months follow-up
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Arian Sultan, MD、Asklepios Klinik St. Georg
- 主任研究者：Stephan Willems, MD、Asklepios Klinik St. Georg
出版物と役立つリンク
一般刊行物
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- Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.
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研究記録日
主要日程の研究
研究開始 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。