Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

Launched by THOMAS ENGSTROM · Feb 15, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at how well a specific treatment works for patients who need a new aortic valve and also have heart artery disease. The study compares two approaches: one involves a procedure called PCI (which opens blocked arteries) guided by a special test to see how severe the blockages are, while the other approach is more conservative and involves monitoring without immediate treatment. The goal is to determine if the PCI method can improve heart health in patients undergoing a procedure called TAVI (Transcatheter Aortic Valve Implantation).

To be part of this trial, participants must be at least 18 years old, have severe narrowing of the aortic valve, and be chosen for TAVI by a team of heart specialists. They also need to have at least one blocked artery that is significant enough to require treatment. Those with certain serious health issues or specific heart conditions may not be eligible. If you join the trial, you'll be closely monitored and receive care based on the study’s guidelines, contributing to valuable research that could help future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
• • 3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis \> 90% in a coronary artery ≥ 2.5 mm in diameter
• Exclusion Criteria:
• • 1. Life expectancy \< 1 year due to other severe non-cardiac disease
• • 2. Severe renal failure with estimated glomerular filtration rate \< 20 ml/min
• • 3. No PCI-eligible coronary artery stenosis, but rotablation is allowed
• • 4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
• • 5. Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
• • 6. Only stenoses with thrombolysis in myocardial infarction grad \< 3
• • 7. Potential pregnancy
• • 8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
• • 9. More than one chronic total occlusion (CTO)