The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial
<p>Abstract</p> <p>Background</p> <p>Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis....
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2013-01-01
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| Series: | Trials |
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| Online Access: | http://www.trialsjournal.com/content/14/1/11 |
| _version_ | 1828554971377827840 |
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| author | Thyregod Hans Gustav Søndergaard Lars Ihlemann Nikolaj Franzen Olaf Andersen Lars Willy Hansen Peter Bo Olsen Peter Skov Nissen Henrik Winkel Per Gluud Christian Steinbrüchel Daniel Andreas |
| author_facet | Thyregod Hans Gustav Søndergaard Lars Ihlemann Nikolaj Franzen Olaf Andersen Lars Willy Hansen Peter Bo Olsen Peter Skov Nissen Henrik Winkel Per Gluud Christian Steinbrüchel Daniel Andreas |
| author_sort | Thyregod Hans Gustav |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting.</p> <p>Methods/Design</p> <p>This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012.</p> <p>Discussion</p> <p>The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: NCT01057173</p> |
| first_indexed | 2024-12-12T05:46:18Z |
| format | Article |
| id | doaj.art-ad41fa27c15f4b928e957caff19bb45a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T05:46:18Z |
| publishDate | 2013-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ad41fa27c15f4b928e957caff19bb45a2022-12-22T00:35:48ZengBMCTrials1745-62152013-01-011411110.1186/1745-6215-14-11The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trialThyregod Hans GustavSøndergaard LarsIhlemann NikolajFranzen OlafAndersen Lars WillyHansen Peter BoOlsen Peter SkovNissen HenrikWinkel PerGluud ChristianSteinbrüchel Daniel Andreas<p>Abstract</p> <p>Background</p> <p>Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting.</p> <p>Methods/Design</p> <p>This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012.</p> <p>Discussion</p> <p>The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: NCT01057173</p>http://www.trialsjournal.com/content/14/1/11Aortic valve stenosisAortic valve prosthesisTranscatheter aortic valve implantationSurgical aortic valve replacementRandomised clinical trial design |
| spellingShingle | Thyregod Hans Gustav Søndergaard Lars Ihlemann Nikolaj Franzen Olaf Andersen Lars Willy Hansen Peter Bo Olsen Peter Skov Nissen Henrik Winkel Per Gluud Christian Steinbrüchel Daniel Andreas The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial Trials Aortic valve stenosis Aortic valve prosthesis Transcatheter aortic valve implantation Surgical aortic valve replacement Randomised clinical trial design |
| title | The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial |
| title_full | The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial |
| title_fullStr | The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial |
| title_full_unstemmed | The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial |
| title_short | The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial |
| title_sort | nordic aortic valve intervention notion trial comparing transcatheter versus surgical valve implantation study protocol for a randomised controlled trial |
| topic | Aortic valve stenosis Aortic valve prosthesis Transcatheter aortic valve implantation Surgical aortic valve replacement Randomised clinical trial design |
| url | http://www.trialsjournal.com/content/14/1/11 |
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