Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation (HYSPANIA)
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system.
The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.
調査の概要
詳細な説明
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system.
The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：FUNDACION EPIC
- 電話番号：0034987876135
- メール：iepic@fundacionepic.org
研究連絡先のバックアップ
- 名前：RAUL MORENO GOMEZ, MD, PhD
- 電話番号：0034917277000
- メール：raulmorenog@hotmail.com
研究場所
-
-
-
Fuencarral-El Pardo、スペイン、28046
- 募集
- Hospital Universitario La Paz
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Santiago de Compostela、スペイン、15706
- 募集
- Hospital Clínico Universitario de Santiago
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
Participants who meet ALL of the following conditions will be included:
- Age ≥ 18 years and;
- Severe aortic stenosis with indication for aortic valve replacement in which a Hydra THV device is implanted according to the instructions for use; and
- Signed informed consent.
Exclusion Criteria:
Patients who do NOT meet ANY of the following conditions will be included:
- Express refusal by the participant to participate in the study.
- Aortic stenosis patients who are not candidates for Hydra THV device implantation or in whom implantation of this device is performed for an indication other than aortic stenosis (especially pure native aortic valve insufficiency). Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses may be included in the study.
- Participants in randomised clinical trials who have not reached the research endpoint.
- Pregnant and/or breastfeeding women.
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 |
|---|---|
|
Hydra Transcatheter Heart Valve (THV)
|
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
|
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 |
|---|---|---|
|
Assessment of the success rate of implantation
時間枠：7 days
|
Assessment of the success rate of implantation defined by:
|
7 days
|
|
Success of the procedure
時間枠：7 days
|
Composite outcome measures defined as a the absence of intra-procedural mortality or complications during implantation, such as: failure to implant the valve at the annulus level, the need to implant more than one valve (valve-in-valve implantation or implantation of a second valve due to embolisation of the first) or surgical intervention on the aortic valve due to severe aortic insufficiency or complications of the procedure.
|
7 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
心血管死亡率
時間枠：12ヶ月
|
心血管死亡率
|
12ヶ月
|
|
All cause mortality
時間枠：7 days
|
Incidence of all cause mortality
|
7 days
|
|
All cause mortality
時間枠：30 days
|
Incidence of all cause mortality
|
30 days
|
|
All cause mortality
時間枠：12 months
|
Incidence of all cause mortality
|
12 months
|
|
Cardiovascular mortality
時間枠：7 days
|
Incidence of cardiovascular mortality
|
7 days
|
|
Cardiovascular mortality
時間枠：30 days
|
Incidence of cardiovascular mortality
|
30 days
|
|
Stroke
時間枠：7 days
|
Incidence of Stroke
|
7 days
|
|
Stroke
時間枠：30 days
|
Incidence of Stroke
|
30 days
|
|
Stroke
時間枠：12 months
|
Incidence of Stroke
|
12 months
|
|
Stroke with disabling
時間枠：7 days
|
Incidence of Stroke with disabling
|
7 days
|
|
Stroke with disabling
時間枠：30 days
|
Incidence of Stroke with disabling
|
30 days
|
|
Stroke with disabling
時間枠：12 months
|
Incidence of Stroke with disabling
|
12 months
|
|
Stroke with non disabling
時間枠：7 days
|
Incidence of Stroke with non disabling
|
7 days
|
|
Stroke with non disabling
時間枠：30 days
|
Incidence of Stroke with non disabling
|
30 days
|
|
Stroke with non disabling
時間枠：12 months
|
Incidence of Stroke with non disabling
|
12 months
|
|
Acute myocardial infarction
時間枠：7 days
|
Incidence of acute myocardial infarction
|
7 days
|
|
Acute myocardial infarction
時間枠：30 days
|
Incidence of acute myocardial infarction
|
30 days
|
|
Acute myocardial infarction
時間枠：12 months
|
Incidence of acute myocardial infarction
|
12 months
|
|
Coronary occlusion
時間枠：7days
|
Incidence of coronary occlusion
|
7days
|
|
Coronary occlusion
時間枠：30 days
|
Incidence of coronary occlusion
|
30 days
|
|
Coronary occlusion
時間枠：12 months
|
Incidence of coronary occlusion
|
12 months
|
|
Haemorrhagic complications
時間枠：7 days
|
Incidence of haemorrhagic complications
|
7 days
|
|
Haemorrhagic complications
時間枠：30 days
|
Incidence of haemorrhagic complications
|
30 days
|
|
Haemorrhagic complications
時間枠：12 months
|
Incidence of haemorrhagic complications
|
12 months
|
|
Vascular complications
時間枠：7 days
|
Incidence of vascular complications
|
7 days
|
|
Vascular complications
時間枠：30 days
|
Incidence of vascular complications
|
30 days
|
|
Vascular complications
時間枠：12 Months
|
Incidence of vascular complications
|
12 Months
|
|
Acute renal failure
時間枠：7 days
|
Incidence of Acute renal failure
|
7 days
|
|
Acute renal failure
時間枠：30 days
|
Incidence of Acute renal failure
|
30 days
|
|
Acute renal failure
時間枠：12 months
|
Incidence of Acute renal failure
|
12 months
|
|
Conduction disturbances
時間枠：7 days
|
Incidence of conduction disturbances
|
7 days
|
|
Conduction disturbances
時間枠：30 days
|
Incidence of conduction disturbances
|
30 days
|
|
Conduction disturbances
時間枠：12 months
|
Incidence of conduction disturbances
|
12 months
|
|
Arrhythmias
時間枠：7 days
|
Incidence of Arrhythmias
|
7 days
|
|
Arrhythmias
時間枠：30 days
|
Incidence of Arrhythmias
|
30 days
|
|
Arrhythmias
時間枠：12 months
|
Incidence of Arrhythmias
|
12 months
|
|
Implantation of a new permanent pacemaker
時間枠：7 days
|
Incidence of Implantation of a new permanent pacemaker
|
7 days
|
|
Implantation of a new permanent pacemaker
時間枠：30 days
|
Incidence of Implantation of a new permanent pacemaker
|
30 days
|
|
Implantation of a new permanent pacemaker
時間枠：12 months
|
Incidence of Implantation of a new permanent pacemaker
|
12 months
|
|
Combined safety event at 30 days defined by Valve Academic Research Consortium 3 (VARC-3) criteria
時間枠：30 days
|
Proportion of patients with freedom from: all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device.
|
30 days
|
|
New York Heart Association (NYHA)
時間枠：7 days
|
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
|
7 days
|
|
New York Heart Association (NYHA)
時間枠：30 days
|
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
|
30 days
|
|
New York Heart Association (NYHA)
時間枠：12 months
|
Proportion of patients with modification of NYHA before the procedure and its modification after the procedure
|
12 months
|
|
Echocardiographic Valve Dysfunction Assessment
時間枠：7 days
|
Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction: Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency |
7 days
|
|
Echocardiographic Valve Dysfunction Assessment
時間枠：30 days
|
Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction: Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency |
30 days
|
|
Echocardiographic Valve Dysfunction Assessment
時間枠：12 months
|
Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction: Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency |
12 months
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.
- Senguttuvan NB, Jose J, Sonawane A, Bansal S, Gupta R, Chandra P. Clinical evaluation of the Hydra self-expanding THV: 30-day results from the GENESIS-II study. AsiaIntervention. 2025 Oct 10;11(3):155-163. doi: 10.4244/AIJ-D-24-00075. eCollection 2025 Oct.
- Aidietis A, Srimahachota S, Dabrowski M, Bilkis V, Buddhari W, Cheung GSH, Nair RK, Mussayev AA, Mattummal S, Chandra P, Mahajan AU, Chmielak Z, Govindan SC, Jose J, Hiremath MS, Chandra S, Shetty R, Mohanan S, John JF, Mehrotra S, Sondergaard L. 30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):93-104. doi: 10.1016/j.jcin.2021.09.004.
- Sonawane A, Chandra P, Jose J, Bansal S, Gupta R, Sudhir K, Senguttuvan NB. Safety and performance of the Hydra self-expanding THV: 6 months outcomes from the GENESIS-II study. Indian Heart J. 2026 Mar 10:S0019-4832(26)00035-0. doi: 10.1016/j.ihj.2026.03.004. Online ahead of print.
- Marin-Cuartas M, Kawczynski MJ, de Waha S, Kiefer P, Falk V, Siepe M, Bowdish ME, Akowuah E, Verbrugghe P, Oosterlinck W, Klautz RJM, Lorusso R, Bidar E, Rahouma MM, Redfors B, Biondi-Zoccai G, Bhatt DL, Gaudino M, Borger MA, Heuts S. Updated 5-year outcomes of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low- to intermediate-surgical risk. Heart. 2026 Feb 11:heartjnl-2025-327092. doi: 10.1136/heartjnl-2025-327092. Online ahead of print.
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。