COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Recruiting
Observational Study
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- Niguarda Hospital · Other
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About This Trial
Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role, recent data underline the possibility of a postponed coronary intervention using a commissural alignment technique. This approach allows easy coronary re-engagement through the valve stent frame with a trade off paid of procedure complexity.
Considering the prevalence of coronary artery disease (CAD) and the…
Trial Locations
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Eligibility Criteria
Patients to be included in this registry should have all the following criteria:
1\. Severe, symptomatic aortic stenosis with an indication to TAVI
Exclusion criteria and definition
Patients excluded in this registry should have all the following criteria:
1. Valve in Valve procedure
2. Hemodyna…
Contacts