A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System (DISCOVER)
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System for the Treatment of Patients With Severe Aortic Stenosis
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial indications. Procedures and assessments required by this registry are generally considered standard of care for Transcatheter Aortic Valve Replacement patients.
Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and angiographic imaging.
調査の概要
詳細な説明
The patient population will include patients who are candidates for transcatheter aortic valve replacement (TAVR). According to routine practice, the heart team (interventional cardiologist and cardiothoracic surgeon) makes a choice to use the Direct Flow Medical Aortic Valve System, compared to other available TAVR prostheses, on the basis of clinical and surgical considerations. Therefore, the valve is implanted when the heart team decides that this product is best suited to the specific patient.
In order to be enrolled in this Registry, the patient must be a candidate for the implantation of the Direct Flow Medical Transcatheter Aortic Valve System, based on the commercial indications as stated in the Instructions for Use.
Therefore, candidates for this study must meet the following criteria (Indications for Use):
- Age > 70 years old
Severe aortic valve stenosis determined by echocardiogram and Doppler:
- mean gradient >40 mmHg or peak jet velocity >4.0 m/s AND
- aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
- Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional Class ≥ II, or syncope).
- Patient is an extreme risk candidate for open surgical aortic valve repair such that the site Investigators (interventional cardiologist and cardiothoracic surgeon) agree that medical factors preclude operation, based on the conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement due to the patient's co-morbidities (such as, but not limited to, severe COPD, porcelain aorta, previous thorax irradiation) or logistic EuroSCORE ≥ 20.
All the Registry clinical evaluations and tests performed are generally considered standard of care for TAVR patients. When these recommendations conflict with the standard of care at the Registry site, the standard of care should prevail. In addition to the standard of care, the Sponsor recommends one brief additional evaluation (the EQ-5D quality of life measure) be conducted. Failure to perform this evaluation shall not be considered a protocol deviation.
Baseline Clinical Evaluation
- Medical History and Physical Exam
- 12 lead ECG and Arrhythmia Assessment
- Logistic EuroSCORE/STS Score
- New York Heart Association (NYHA) functional status
- Modified Rankin Score Assessment (mRS)
- Current Cardiac Medications Baseline Imaging Studies
- Transthoracic Echo (TTE)
- CT Scan (ECG triggered, contrast enhanced)
Aorto-Iliac Angiogram:
- Peripheral Evaluation
- Coronary Evaluation
All patients will have clinical follow-up at hospital discharge, 30 days, 12 months and annually to 3 years and undergo the following evaluations:
- Physical Exam
- 12 lead ECG and Arrhythmia Assessment
- New York Heart Association (NYHA) functional status
- Modified Rankin Score Assessment (mRS) if symptomatic for stroke
- Current Cardiac Medications
- Transthoracic echo (TTE) Patients in whom the heart team has planned to use the Direct Flow Medical Transcatheter Aortic Valve System valve, are informed of the DISCOVER Registry and their consent to participate is required. This study intends to monitor the clinical condition of the patient for a period of 3 years after the operation. By agreeing to participate, the patient agrees to undergo clinical assessments and specific tests at certain intervals (prior to the procedure; during the implantation; at hospital discharge, at 30 days after the procedure, and at 1 year, 2 and 3 years later); the patient also agrees to the collection of these daThe purpose of this Registry is to monitor outcomes data for the Direct Flow Medical Transcatheter Aortic Valve System in the Post Market phase. The primary outcome of interest is freedom from all-cause mortality at 30 days. The results from the pivotal CE mark study (IP 010) yielded a 30 day freedom from all-cause mortality rate of 97%. Should the "true" rate be 97%, then N=250 patients would provide an estimate of the rate with a margin of error of 2%, with 95% confidence.
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:Christopher Naber, MD
- 電話番号:+49201897 0
- メール:c.naber@contilia.de
研究連絡先のバックアップ
- 名前:Mary Edwards
- 電話番号:462 7075760420
- メール:medwards@directflowmedical.com
研究場所
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Milan、イタリア、20162
- 募集
- Ospedale Niguarda Ca' Granda
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主任研究者:
- Federico DeMarco, MD
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コンタクト:
- Federico DeMarco, MD
- 電話番号:+390264442585
- メール:federico.demarco@gmail.com
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Essen、ドイツ、45138
- 募集
- Elisabeth Krankenhaus
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コンタクト:
- Christopher Naber, MD
- 電話番号:+492018970
- メール:c.naber@contilia.de
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コンタクト:
- Elisabeth Blank, RN
- 電話番号:+49 201 8973218
- メール:e.blank@contilia.de
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主任研究者:
- Christopher Naber, MD
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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
Candidates for this study must meet all of the Indications criteria and none of the Contraindications.
Inclusion Criteria (Indications):
- Age > 70 years old
Severe aortic valve stenosis determined by echocardiogram and Doppler:
- mean gradient >40 mmHg or peak jet velocity >4.0 m/s
- aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
- Symptomatic aortic valve stenosis (angina, congestive heart failure, NYHA Functional Class ≥ II, or syncope).
- Patient is an extreme risk candidate for open surgical aortic valve repair such that the site Investigators (interventional cardiologist and cardiothoracic surgeon) agree that medical factors preclude operation, based on the conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement due to the patient's co-morbidities (such as, but not limited to, severe COPD, porcelain aorta, previous thorax irradiation) or logistic EuroSCORE ≥ 20.
Exclusion Criteria (Contraindications):
The Direct Flow Medical device is contraindicated for post implant balloon valvuloplasty.
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
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
aortic valve disease
aortic valve replacement
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Transthoracic Echo (TTE),CT Scan (ECG triggered, contrast enhanced),Aorto-Iliac Angiogram,Peripheral Evaluation,Coronary Evaluation,12 lead ECG,Arrhythmia Assessment, New York Heart Association (NYHA) functional status, Modified Rankin Score Assessment (mRS) if symptomatic for stroke, Current Cardiac Medications, Transthoracic echo (TTE)
他の名前:
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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 |
時間枠 |
---|---|
Freedom from all-cause mortality at 30 days
時間枠:30 days
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30 days
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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 |
---|---|---|
Device Success (VARC defined)
時間枠:30 days
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30 days
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Early Safety
時間枠:30 days
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30 days
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Clinical efficacy
時間枠:30 days through 5 years
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30 days through 5 years
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Clinical efficacy
時間枠:30 days through 5 years
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• NYHA Class III or IV
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30 days through 5 years
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Clinical efficacy
時間枠:30 days through 5 years
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• Prosthetic heart valve dysfunction (mean aortic valve gradient ≥20mm Hg, EOA ≤0.9-1.1cm2
[depending on body surface area] and/or DVI <0.35, AND/OR moderate or severe prosthetic valve regurgitation)
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30 days through 5 years
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Time-related Valve Safety
時間枠:5 years
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• Structural valve deterioration:
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5 years
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Time-related Valve Safety
時間枠:5 years
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5 years
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協力者と研究者
捜査官
- 主任研究者:Christopher Naber, MD、Elisabeth Krankenhaus Essen GmbH
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
- RP 001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。
Aortic Valve Replacementの臨床試験
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Institut für Pharmakologie und Präventive MedizinEdwards Lifesciences積極的、募集していない
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Caisson Interventional LLC積極的、募集していない僧帽弁閉鎖不全症 | 心臓弁膜症 | 弁膜症 | 僧帽弁疾患 | 僧帽弁不全 | 僧帽弁疾患アメリカ
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Symetis SA完了大動脈弁狭窄症ドイツ, デンマーク, スイス
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Symetis SA完了症候性大動脈弁狭窄症ドイツ, イタリア, アルゼンチン, スイス
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Medtronic Cardiovascular利用できない
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Chinese Academy of Medical Sciences, Fuwai Hospitalまだ募集していません
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Symetis SA完了