Evaluation of Hybrid Cardiac Procedures for Heart Disease
Prospective Evaluation for Hybrid Cardiac Procedures
This study is testing if new combined heart procedures can help people with different heart problems feel better and recover faster than traditional treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05143671 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of hybrid cardiac procedures in patients with various heart conditions, including coronary artery disease and valve disease. It employs a multidisciplinary team approach to provide personalized treatments using hybrid operative rooms, which combine surgical and transcatheter techniques. The study focuses on three patient subgroups: those undergoing hybrid coronary revascularization, hybrid valve and coronary disease correction, and hybrid treatment for coronary and carotid artery disease. The investigators aim to determine if these hybrid procedures can significantly reduce morbidity compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with coronary artery disease requiring revascularization and specific anatomical considerations.
Not a fit: Patients with conditions not requiring revascularization or those unable to tolerate dual antiplatelet therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients with complex heart diseases.
How similar studies have performed: Other studies have shown promise in hybrid approaches for cardiac procedures, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma
- IRCCS Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Piergiorgio Bruno, MD
- Study coordinator: Marialisa Nesta, MD
- Email: marialisa.nesta@policlinicogemelli.it
- Phone: +39 3495667812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.