NCT03283501

Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)

A Multicenter Observational Registry on Coronary Revascularization After Implantation of Transcatheter Aortic Valve Bioprosthesis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: San Luigi Gonzaga Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Detailed description

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 1. Evaluate the incidence of PCI after TAVI 2. Evaluate the clinical indications for PCI after TAVI 3. Evaluate the technical feasibility of PCI in patients with prior TAVI 4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI

Conditions

• Transcatheter Valve Implantation
• TAVI

Interventions

Type	Name	Description
PROCEDURE	PCI after TAVI	Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI

Timeline

• Start date: 2017-04-20
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2017-09-14
• Last updated: 2017-09-14

Locations

3 sites across 2 countries: Italy, Spain