COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital
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 increasing percentage of younger patients treated with TAVI, investigate whether a simpler procedure with random implantation of Navitor valve is not inferior in terms of coronary re-access, is required The key point of the project will be the evaluation of the feasibility of coronary re-engagement after a Navitor valve randomly implanted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Valve in Valve procedure
Hemodynamical instability
TAVR performed from other access (not femoral)
No-CT Planned TAVR
Trial population
Consecutive patients with severe aortic stenosis diagnosed according to ESC guidelines, undergoing transcatheters aortic valve replacement with Navitor valve randomly implanted or Acurate Neo with commisural alignment technique
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TAVR Aligned
Procedure/SurgeryInvestigate the feasibility of coronary re-engagement after commissural alignment technique in terms of success rate (%) and procedure complexity taking into account radiations, time and contrast used.
TAVR Random
Procedure/SurgeryTAVR Random Feasibility comparison of coronary re-engagement between the randomly implanted Navitor valve (unaligned) and the others implanted with the commissural alignment technique in terms of success rate (%) and complexity of the procedure, taking into account radiation, time and contrast used
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: TAVR performed with commissural alignment technique (Aligned Group)2 interventions
Group B: TAVR performed with random implantation of Navitor valve (Random Group)2 interventions
Trial outcomes
Primary outcomes
1
Coronary re-access after TAVR procedure
Re-engagement of LMCA and RCA after valve implantation is defined as selective cannulation and subsequent selective angiography. All others type of re-engagement will be classify as "non selective". We will stratify also the modality of re-cannulation in relation to the position of the valves' stent struts as "above", "across" and "behind".
Time frame
During procedureSecondary outcomes
1
Total Implant Time
Total time required for valve implantation. We count the time from the alignment in the aorta to the end of valve opening (Alignment Fluoroscopy time + Implantation Fluoroscopy time).
Time frame
During procedure2
Total Implant Fluoroscopy Time
Total Fluoroscopy time required for valve implantation. We count the time from the alignment in the aorta to the end of valve opening (Alignment time + Implantation time).
Time frame
During procedure3
Total Implant Radiations
Total Radiations required for valve implantation. We count the radiations used from the alignment in the aorta to the end of valve opening (Alignment time + Implantation time).
Time frame
During procedure4
Total Implant Contrast
Total Contrast required for valve implantation
Time frame
During procedureSponsors and contacts
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Source ClinicalTrials.gov