Prospective Evaluation for Hybrid Cardiac Procedures

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Nov 20, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment options for patients with various heart conditions, including serious issues with the coronary arteries and heart valves. The study is looking at “hybrid procedures,” which combine different types of heart surgeries and non-surgical treatments in a specialized operating room. The goal is to see if these combined approaches can make heart procedures safer and reduce complications by up to 50% compared to traditional methods.

To participate in this trial, individuals must be at least 18 years old and have specific heart conditions that require treatment, such as coronary artery disease or severe valve problems. They should be able to tolerate certain medications and be willing to follow the study’s requirements for follow-up care. However, some people may not qualify, such as those who have had previous heart surgeries or serious health issues that could affect their recovery. If you or a loved one is considered for this trial, you can expect careful monitoring and a personalized approach to treatment, designed to improve heart health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent, inclusive of release of medical information
• • Age ≥ 18 years
• • CAD with indication for revascularization
• * Coronary anatomy as follows:
• • Multivessel-CAD involving the left anterior descending (LAD) (proximal or mid) and/or the left main (LM) (ostial, mid-shaft or distal) with at least one further epicardial coronary artery requiring treatment (LCX or RCA), OR
• • Single vessel disease involving the LAD and a major diagonal, both requiring independent revascularization with at least one stent
• • Severe aortic stenosis/insufficiency and/or mitral stenosis/insufficiency requiring surgery, with CAD (involving one or more vessels), suitable for PCI
• • CAD with indication for revascularization with severe unilateral carotid stenosis (\>85%)
• * Ability to tolerate, and no plans to interrupt dual antiplatelet therapy (DAPT) for:
• • At least 6 months in presentation was stable CAD,
• • At least 12 months if presentation was a biomarker-positive acute coronary syndrome (ACS)
• • Willing to comply with the follow-up required by the protocol.
• Exclusion Criteria:
• • Previous cardiac surgery of any kind
• • Previous thoracic surgery involving the left pleural space (if a left thoracotomy approach is planned)
• • Complicated or unsuccessful PCI within 30 days prior
• • Total occlusion (TIMI 0 or 1 flow) of the LM or LAD
• • Cardiogenic shock at time of screening
• • Any prior lung resection
• • End-stage renal disease on dialysis
• • Extra-cardiac illness that is expected to limit survival to less then 5 years
• • Allergy or hypersensitivity to any of the study drugs or devices used in protocol
• • Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgement of the investigator
• • Pregnant at time of screening, or unwilling to use effective birth control measures while dual antiplatelet therapy is required.