A Prospective, Randomized, Blind, Controlled Multicenter Clinical Study Comparing the Effectiveness of Preventive Ventricular Arrhythmia Ablation on the Prognosis After Left Ventricular Assist Device (LVAD) Surgery. (PAVA-LVAD)
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Anhui
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Hefei、Anhui、中国
- 5thBuilding, 9thFloor, High-tech Campus of the First Affiliated Hospital of Anhui Medical University
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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:
- 1.voluntary and with the provision of an informed consent form 2.males or females aged 18 years or older 3.all patients with acute and critical or chronic advanced heart failure who have failed to respond to standardized oral medication and are scheduled to undergo artificial heart implantation surgery
Exclusion Criteria:
1.The left ventricular assist system is prohibited for patients who cannot tolerate anticoagulant therapy or who are allergic to anticoagulant treatment.
2.Doctors with sufficient experience will make a comprehensive judgment based on the patient's physical condition, body surface area, and the anatomical-related conditions of the planned implantation site, and determine those who are not suitable for the implantation procedure.
3.Pregnant women. 4.Systemic active infection. 5.Patients in a state of brain death. 6.Irreversible severe liver or kidney dysfunction. 7.Having a history of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease.
8.primary pulmonary hypertension. 9.Having a confirmed and untreated history of abdominal or thoracic aortic aneurysm with a diameter greater than 5 cm.
10.Patients with severe atherosclerotic plaques in the aorta. 11.Having mental disorders/impairments, irreversible cognitive dysfunction, or social-psychological problems, which makes it possible for the patient to fail to comply with the application management regulations of the implanted left ventricular assist device.
12.Preoperative conditions included end-stage organ failure, such as renal failure (requiring hemodialysis), liver failure, respiratory failure; and concurrent malignant tumors or any severe accompanying diseases with an expected lifespan of less than 3 years.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：preventive ablation group
for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
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for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
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介入なし：the control group without any treatment
no intervention measures
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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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persistent ventricular tachycardia / ventricular fibrillation
時間枠：Continuous electrocardiogram monitoring for 30 days after surgery
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Electrocardiogram monitoring was conducted daily for the patients 30 days after the surgery.
Data were uploaded daily and the frequency of arrhythmia occurrences was statistically analyzed.
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Continuous electrocardiogram monitoring for 30 days after surgery
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all-cause mortality
時間枠：Within 30 days after the operation
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Conduct a 30-day follow-up visit for the patients, and collect the time and cause of death.
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Within 30 days after the operation
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mechanical thrombus
時間枠：Within 30 days after the operation
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Electrocardiogram monitoring was performed daily on the patients 30 days after the surgery.
When thrombosis occurred, the left heart assist device would give an alarm to alert.
In some cases, autopsy could be conducted to obtain the results.
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Within 30 days after the operation
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right heart failure
時間枠：Within 30 days after the operation
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Conduct a 30-day follow-up visit for the patients, and collect the time and cause of right heart failure.
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Within 30 days after the operation
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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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all-cause mortality
時間枠：semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months to collect death-related records such as death certificates and discharge summaries.
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semi-annually, for a total of three years
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mechanical thrombus
時間枠：semi-annually, for a total of three years
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The artificial heart device implanted in the patient will continuously monitor.
When a thrombosis occurs, the left heart assist device will alert and remotely contact the medical team.
In some cases, this information can be obtained through autopsy after death.
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semi-annually, for a total of three years
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stroke
時間枠：semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records, imaging reports (such as head CT or MRI), and other original materials are collected.
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semi-annually, for a total of three years
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Hospitalization or emergency visit due to heart failure
時間枠：semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected, including symptoms such as shortness of breath and signs such as lower extremity edema, measurement of brain natriuretic peptide levels, and treatment with diuretics, etc.
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semi-annually, for a total of three years
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heart transplantation
時間枠：semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected.
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semi-annually, for a total of three years
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協力者と研究者
協力者
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。