Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap

Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43320

Enrollment

Registered

2017-02-03

Start date

2017-10-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

Interventions

Aortic Valve/Surgery

Bioprosthesis

Tissue Scaffolds

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Indication for aortic valve replacement according to current medical guidelines in valvular heart disease. 2. Informed consent of legal guardians or patients, assent of patients.

Exclusion criteria

Exclusion criteria: 1. The patient has not provided surveillance informed consent. 2. The patient shall not suffer from a. generalized connective tissue disorders (e.g. Marfan syndrome), or b. active rheumatic disorders, or c. severe asymmetric calcification of the valve ring. 3. The coronary arteries of the patient shall not be in abnormal position or heavily calcified. 4. Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.

Design outcomes

Primary

Measure	Time frame
Primary safety endpoints: 1. Cardiovascular Adverse Reactions, e.g. all-cause mortality, major stroke, life-threatening (or disabling) bleeding, acute kidney injury-stage 3 (including renal replacement therapy), peri-procedural myocardial infarction, major vascular complication, repeat procedure for valve-related dysfunction (surgical or interventional therapy). 2. Serious Adverse Reactions, e.g. infections, immunological reactions, etc. Primary efficacy endpoint: Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.	—

Measure

Time frame

Primary safety endpoints: 1. Cardiovascular Adverse Reactions, e.g. all-cause mortality, major stroke, life-threatening (or disabling) bleeding, acute kidney injury-stage 3 (including renal replacement therapy), peri-procedural myocardial infarction, major vascular complication, repeat procedure for valve-related dysfunction (surgical or interventional therapy). 2. Serious Adverse Reactions, e.g. infections, immunological reactions, etc. Primary efficacy endpoint: Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.

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Secondary

Measure	Time frame
Secondary safety endpoints: 1. Blood parameters as additional safety data to support presence/absence of adverse reactions. 2. Time to reoperation, explantation and/or death. Secondary efficacy endpoints (i.e. at end of the study in comparison to at implantation): 1. Diameters of the ARISE AV. 2. Transvalvular gradients. 3. Valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging.	—

Measure

Time frame

Secondary safety endpoints: 1. Blood parameters as additional safety data to support presence/absence of adverse reactions. 2. Time to reoperation, explantation and/or death. Secondary efficacy endpoints (i.e. at end of the study in comparison to at implantation): 1. Diameters of the ARISE AV. 2. Transvalvular gradients. 3. Valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)