ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Zarina Habibi, MD
- 電話番号:+31-43-3881200
- メール:ablatie.onderzoek@gmail.com
研究連絡先のバックアップ
- 名前:Dominique Verhaert, MD
- メール:ablatie.onderzoek@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 18 years of age or older;
- Documented atrial fibrillation;
- Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Conditions preventing the patient from adhering from the study protocol;
- Emergency procedures.
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:
- Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
- Severe allergic reaction against body surface electrodes
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:
• Status after esophageal or gastric surgery
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:
• Contraindication to MRI
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:
• Prior catheter or surgical AF ablation.
Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):
- Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
- Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
- Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.
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
- 観測モデル:コホート
- 時間の展望:見込みのある
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 |
---|---|---|
Ablation success
時間枠:12 months
|
Freedom from documented recurrence of atrial arrhythmia after 12 months.
Recurrences in the first 3 months after the index procedure (blanking period) are exempted.
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time to recurrence of AF or other atrial arrhythmia after the blanking period.
時間枠:3 to 24 months
|
Time to recurrence of AF or other atrial arrhythmia after the blanking period of 3 months.
|
3 to 24 months
|
Early recurrences of AF or other atrial arrhythmia
時間枠:0 to 3 months
|
Defined as any episode of documented arrhythmia during the blanking period, defined as within 3 months
|
0 to 3 months
|
Number of participants with disease progression to persistent or permanent AF.
時間枠:0 to 24 months
|
Disease progression to persistent or permanent AF.
Persistent AF is defined as AF that lasts longer than 7 days.
Permanent AF can't be corrected with treatments.
|
0 to 24 months
|
Use of antiarrhythmic drugs (AADs) one year after ablation.
時間枠:0 to 24 months
|
Use of antiarrhythmic drugs (AADs) one year after ablation
|
0 to 24 months
|
Interleukin 6 (IL-6) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Pro-brain natriuretic peptide 2 (pro-BNP2) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Fibroblast growth factor 23 (FGF-23) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Dickkopf-related protein 3 (DKK-3) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Angiopoietin 2 (ANG-2) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Endothelial cell-specific molecule 1 (ESM-1) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Insulin-like growth factor-binding protein 7 (IGFBP-7) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Bone morphogenetic protein 10 (BMP-10) level
時間枠:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Redo procedures
時間枠:0 to 24 months
|
Defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal.
|
0 to 24 months
|
Number of veins with pulmonary vein reconnection at redo procedure.
時間枠:0 to 24 months
|
Number of veins with pulmonary vein reconnection at redo procedure.
|
0 to 24 months
|
Major adverse cardiovascular events (MACE).
時間枠:0 to 24 months
|
Major adverse cardiovascular events (MACE).
|
0 to 24 months
|
Procedure time
時間枠:Intraoperative
|
Defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths).
|
Intraoperative
|
協力者と研究者
捜査官
- 主任研究者:Kevin Vernooy, MD. PhD、Maastricht UMC+ & Radboudumc
- 主任研究者:Dominik Linz, MD, PhD、Maastricht UMC+ & Radboudumc & University of Adelaide and Royal Adelaide Hospital & University of Copenhagen
- 主任研究者:Ulrich Schotten, MD, PhD、Maastricht University & Cardiovascular Research Institute Maastricht
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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。