Trials / Completed

CompletedNCT05143671

Prospective Evaluation for Hybrid Cardiac Procedures

Status: Completed
Phase: —
Study type: Observational
Enrollment: 134 (actual)

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream in cardiovascular medicine. "Hybrid operative rooms" allow to offer selected heart-disease patients truly "tailored" operations. This study wants to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients in three subgroups of patients: * Hybrid coronary revascularization strategy (coronary by-pass + PCI); * Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI); * Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting). The investigators hypothesize that morbidity might be reduced by 50% in hybrid procedures group as compared with predicted Society of Thoracic Surgery (STS) score.

Detailed description

Cardiovascular medicine is actually evolving fast and multidisciplinary team-approach in order to offer personalized treatments represents the emerging mainstream. The possibility to realize combinations of treatments traditionally available only in the catheterization laboratory and in the operating room represent the rationale for "hybrid operative rooms" facilities allowing to offer selected heart-disease patients truly "tailored" operations. Such "Hybrid" management strategies usually combine transcatheter techniques and surgery (often minimally invasive) in order to combine the reduced invasiveness of the former with the effectiveness of the latter. Common examples of surgical and transcatheter combinations are: hybrid revascularization performed with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI); combined heart valve and coronary disease treated with valve surgery and PCI; combined endo- and epicardial ablation of atrial fibrillation; thoracic aneurysms treated with endovascular stenting and surgical debranching of the arch; carotid artery stenting along with CABG. Given the relatively recent development of these techniques, indications and patient selection are yet to be defined and a productive collaboration between surgeons and interventional cardiologists is of paramount importance. Aim of the study is to evaluate the effectiveness and safety of Hybrid Procedures in cardiac patients. Specifically, three subgroups will be analysed: * Hybrid coronary revascularization strategy (HCR, coronary by-pass + PCI); * Hybrid valve and coronary disease correction (combination of surgical valve replacement and PCI); * Hybrid coronary and carotid artery disease treatment (combination of coronary by-pass and carotid stenting). The local Heart Team (cardiac surgeon, interventional cardiologist, clinical cardiologist and anaesthetist) will decide which patients will be referred for hybrid treatment. Typically, this happens when the Heart Team feels that hybrid treatment could reduce the overall risk of a combined procedure. The patient population consists of adult patients with: * Multi-vessel coronary artery disease (CAD) involving the left main and/or the left anterior descending artery with indication for revascularization; * Severe, symptomatic valvular disease and CAD with indication for revascularization; * Significant unilateral carotid stenosis and CAD with indication for revascularization. In a previous data review board on the Heart Team activity, we recognized that 10% of discussed patients are referred for hybrid procedures (HP) and that observed operative mortality was strongly lower than that predicted by STS and EuroSCORE (2.5% versus 10.1% and 5.9%, respectively). Morbidity was not prospectively investigated. For sample size estimation, the investigators hypothesized that Morbidity might be reduced by 50% in HP group as compared with predicted STS. The mean expected STS morbidity estimated in the study population is 32.57%. Accordingly, a total number of 111 patients with an alpha error of 5% and a beta error of 20% has been calculated to be needed to test this hypothesis.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Coronary artery bypass grafting	Coronary artery bypass grafting in coronary revascularization.
PROCEDURE	Percutaneous coronary intervention	Percutaneous coronary intervention in coronary revascularization.
PROCEDURE	Surgical valve replacement	Surgical mitral and / or aortic valve replacement.
PROCEDURE	Carotid artery stenting	Carotid artery stenting.

Timeline

Start date: 2021-05-13
Primary completion: 2025-07-30
Completion: 2025-07-30
First posted: 2021-12-03
Last updated: 2025-08-14

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05143671. Inclusion in this directory is not an endorsement.