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Older AS-patients invasive therapy study: oASis, a prospective study.


- candidate number14259
- NTR NumberNTR3831
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jan-2013
- Secondary IDs2011-489 METC Erasmus MC
- Public TitleOlder AS-patients invasive therapy study: oASis, a prospective study.
- Scientific TitleOlder AS-patients invasive therapy study: oASis, a prospective study.
- ACRONYMOASIS pros
- hypothesisWith the emergence of lesser invasive strategies to treat AS, it is expected that an increasing number of patients -who were previously not referred for invasive treatment for AS- will be referred to our center. Also, it is anticipated that with the expanding use of lesser invasive strategies to treat aortic valve disease, more and more selected patients who previously underwent AVR will be treated using lesser invasive strategies.
- Healt Condition(s) or Problem(s) studiedAortic valve stenosis, Aortic Valve Replacement
- Inclusion criteriaAge 18 years and older, severe aortic valve disease with or without coronary artery disease, severe aortic stenosis with non-severe mitral regurgitation that may or may not require mitral valve surgery.
- Exclusion criteriaSevere mitral regurgitation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 7-dec-2011
- planned closingdate1-jan-2015
- Target number of participants150
- InterventionsA systematic uniform registration of patient characteristic, procedural aspects, and follow-up for the purpose of:
1. Optimized multidisciplinary patient care;
2. Uniform scientific reporting;
3. Assessment of quality of care and referral trends over time.+ QoLSs*.
* QoLs : VAS, EQ5D, Katz ADL.

Given the anticipated expanding use of lesser invasive strategies to treat AS, the steadily growing elderly population with severe AS, and the increasing societal demand for highest quality at lowest cost care, there is an urgent need for systematic registration of this patient group and the effectiveness of the chosen treatment strategies.
- Primary outcomeOptimized multidisciplinary patient care.
- Secondary outcome1. Uniform scientific reporting;
2. Assessment of quality of care and referral trends over time.
- Timepoints1. Baseline;
2. Procedural;
3. 30 days;
4. 6 months;
5. 1 year.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.J.M. Takkenberg
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J.M. Takkenberg
- Sponsor/Initiator Erasmus Medical Center, Department of Cardio-thoracic Surgery
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Cardio-thoracic Surgery
- PublicationsN/A
- Brief summaryBackground and rationale:
With the aging, it is expected that the health burden of aortic stenosis will increase considerably. Traditionally the treatment of symptomatic severe AS is AVR. However, a considerable proportion of patients is not referred for surgery, especially older patients with multiple co morbidities. Minimal invasive catheter techniques have been developed to implant a biological valve substitute in patients with severe AS.
There is a new and rapidly growing group of elderly patients with severe AS for whom these lesser invasive treatment methods are currently becoming available. This group of patients has a relatively short life expectancy and the weighing of costs and benefits of invasive treatment becomes increasingly important as the main goal of the treatment is to provide a better quality of life. In addition, it is expected that in the future lesser invasive treatment methods will become available for younger patients with severe aortic valve disease of varying etiology.

Hypothesis:
With the emergence of lesser invasive strategies to treat AS, it is expected that an increasing number of patients will be referred to our center. Also, it is anticipated that more and more selected patients who previously underwent AVR will be treated using lesser invasive strategies.

Objectives:
It is proposed to initiate a prospective registry of all patients with severe aortic valve disease who are 18 years or older and are referred for invasive treatment of their aortic valve disease in order to ascertain a systematic uniform registration of patient characteristic, procedural aspects, and follow-up for the purpose of (1) optimized multidisciplinary patient care, (2) uniform scientific reporting, and (3) assessment of quality of care and referral trends over time.

Study design:
Prospective registry.

Study population:
Population: All patients with aortic valve disease age 18 years or older who are referred to Erasmus MC for the invasive treatment of aortic stenosis (AVR, TAVI, medical Tx).

Inclusion criteria:
Age 18 years and older, severe aortic valve disease with or without coronary artery disease, severe aortic stenosis with non-severe mitral regurgitation that may or may not require mitral valve surgery.

Exclusion criteria:
Severe mitral regurgitation.
- Main changes (audit trail)
- RECORD24-jan-2013 - 11-feb-2013


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