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Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2). Giving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events. Despite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of less is more (only SAPT or only OAC) regardless the risk level (5-6). The keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All patients with severe aortic stenosis undergoing TAVR.

• Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.

Locations
Other Locations
Belgium
OLV Hospital
RECRUITING
Aalst
Chile
Complejo Asistencial Dr. Sótero del Río
RECRUITING
Santiago
Italy
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
ASST GOM Niguarda
RECRUITING
Milan
Ospedale Galeazzi Sant'Ambrogio
RECRUITING
Milan
San Carlo Hospital
RECRUITING
Potenza
Azienda Ospedaliera Sant'Andrea
RECRUITING
Roma
Humanitas Research Hospital
RECRUITING
Rozzano
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
A.O.U. Città della Salute e della Scienza di Torino
RECRUITING
Torino
Spain
Puerto Real University Hospital, Puerto Real
RECRUITING
Cadiz
Contact Information
Primary
Giuseppe Esposito, MD
giuseppe.esposito@yahoo.com
+393278393131
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 2500
Treatments
Lower Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
Intermediate Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
High Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
Sponsors
Leads: Niguarda Hospital

This content was sourced from clinicaltrials.gov

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