Clinical trial NCT05779787: COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Official title: COronary Re-EngageMent aFter RandOm NavitoR Alignment (COMFORT STUDY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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.

Detailed description: Transcatheter Aortic Valve Implantation (TAVI) is recommended by European and American guidelines to treat patients with aortic stenosis regardless of procedural risk (1, 2). In the last decades the increasing percentage of younger patients treated with TAVI, reflect the extensive indications in lower risk setting, highlighting the importance of easy coronary re-engagement after valve implantation. Considering the prevalence and the progression of a pre-existing coronary artery disease (CAD), the timing of coronary intervention should be accurate selected (3) addressing the percentage of unplanned percutaneous coronary intervention (PCI) after TAVI (4). In fact, while PCI before TAVR was previously recommend despite the uncertain prognostic role (5), recent data remarks the possibility of a postponed coronary intervention using a commissural alignment technique (6) that allows a predictable stent frame position in the sinus of Valsalva (7). Moreover, following the emerging concept of easy re-access, only a few types of prostheses have been shown to have an high degree of stent position predictability after implantation, leading to a limited option in terms of prosthesis choice. Furthermore, to achieve the best results with commissural alignment technique, accurate procedure planning and operator's expertise are required in order to properly manage the valve specific orientation in the aorta with consequent increase in time, radiation and procedure complexity.

However, geometry of the stent frame (height and size) and the anatomical characteristics of patients have to be enlisted as contributory factors to difficult coronary re-engagement and need to be evaluate in order to establish the feasibility of the re-access after TAVR.

The investigators' findings could provide data regarding the non-inferiority rate of coronary cannulation after a simpler procedure with Navitor implantation without alignment technique. Due to these results, the valves portfolio available in patients with coronary artery disease that needed PCI after TAVR, could be larger and various allowing the best protheses choice according to the patient's anatomy and operator's expertise. Finally, knowing the predictors of difficult re-engagement for both types of valves, regardless of implantation technique, could be interesting for an even more valve tailored approach.

The purpose of this study is to investigate the feasibility of coronary re-engagement after randomly (not aligned) Navitor implantation, as already perform in current clinical practice, due to a lower predictable orientation of this type of valve.

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. Hemodynamical instability
3. TAVR performed from other access (not femoral)
4. No-CT Planned TAVR
5. TAVR performed with Chimney Technique

Primary outcomes:
measure: Coronary re-access after TAVR procedure
timeFrame: During procedure
Secondary outcomes:
measure: Total Implant Time
timeFrame: During procedure
measure: Total Implant Fluoroscopy Time
timeFrame: During procedure
measure: Total Implant Radiations
timeFrame: During procedure
measure: Total Implant Contrast
timeFrame: During procedure
measure: Alignment Radiation
timeFrame: During procedure
measure: Alignment Fluoroscopy Time
timeFrame: During procedure
measure: Implant Radiation
timeFrame: During procedure
measure: Implant Fluoroscopy Time
timeFrame: During procedure
measure: Implant Contrast
timeFrame: During procedure
measure: Re-Engagement Radiation
timeFrame: During procedure
measure: Re-Engagement Fluoroscopy Time
timeFrame: During procedure
measure: Re-Engagement Contrast used
timeFrame: During procedure
measure: Re-Engagement Time
timeFrame: During procedure
Other outcomes:
Locations:
city: MIlano
country: Italy
facility: ASST GOM Niguarda
state: Lombardia
Study officials:
References: