An observational study in Transcatheter Valve Implantation and TAVI, sponsored by San Luigi Gonzaga Hospital. Status unknown at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-14.
Sponsored by San Luigi Gonzaga Hospital · Observational
Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series.
Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.
Objectives
Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
Exclusion Criteria:
Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
Evaluate the incidence of PCI after TAVI
Evaluate the incidence of PCI after TAVI
Time frame: up to 5 year after TAVI implantation
Evaluate the clinical indications for PCI after TAVI
Clinical indication for PCI: stable angina; documented silent ischemia; acute coronary syndrome/non-ST elevation myocardial infarction; acute coronary syndrome/ST elevation myocardial infarction
Time frame: intraoperative
Evaluate the technical feasibility of PCI in patients with prior TAVI
Successful target coronary vessel revascularization
Time frame: intraoperative
Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI
outcome defined as MACE (Major Adverse Coronary Event) a composite of Death, Myocardial Infarction, Target Lesion Failure
Time frame: up to 5 year after TAVI implantation
Plan to share: Undecided
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
San Luigi Gonzaga Hospital