TAVI Clinical Trial
Official title:
Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
The method of transcatheter aortic valve implantation (TAVI) which was introduced in 2002 by
Alain Cribier et al. has offered new prospects for patients with severe aortic stenosis and
multiple comorbidities, for whom surgical procedures are associated with exceedingly high
operative risk (1,2).
The randomized multicenter PARTNER trial (Placement of Aortic Transcatheter valve Trial)
proved that TAVI is an alternative for surgical aortic valve replacement (SAVR) for high-risk
patients.TAVI is characterized by similar mortality and results in terms of reducing the
symptoms of stenosis (3).
Current recommendations by the European Society of Cardiology in the Guidelines on the
management of valvular heart disease (4) are that TAVI should be carried out in patients with
a life expectancy >1 year, who deemed inoperable or high-risk by a cardiac surgeon and who
are likely to gain improvement in quality of life. (5).
One of the complications based on the consensus of experts (the Valve Academic Research
Consortium-2 (VARC-2 criteria)) is Conduction defect (6).
The mechanical interaction of the prosthesis stent frame with the conduction system and left
bundle branch may lead to a high degree of or complete AV block and to left bundle branch
block (LBBB) after TAVI.(7)
The pathophysiology of new conduction abnormalities has not yet been elucidated. A number of
studies indicate that both patient and procedure related factors such as septal wall
thickness, non-coronary cusp thickness, pre-existing RBBB, depth of valve implantation within
the LVOT, post implant prosthesis expansion, and the type of prosthesis play a role , LVOT/
annulus ratio, LVOT/Prosethesis diameter..(8)(9)(10)(11)(12)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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||
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| Completed |
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| Completed |
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||
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| Completed |
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|
Phase 3 | |
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|
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| Active, not recruiting |
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| Recruiting |
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|
N/A |