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NCT05143671Completed

Prospective Evaluation for Hybrid Cardiac Procedures

Source: ClinicalTrials.gov · Last updated 14 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
134 (actual)
First submitted
5 Nov 2021
Start date
13 May 2021
Primary completion date
30 Jul 2025
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT05143671

What you commit to

  • Study type: Observational
  • Participants enrolled: 134
  • From 13 May 2021 to the primary completion date, 30 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Any prior lung resection
  • Pregnant at time of screening, or unwilling to use effective birth control measures while dual antiplatelet therapy is required.

Other illness

  • 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

Other

  • Total occlusion (TIMI 0 or 1 flow) of the LM or LAD
  • Cardiogenic shock at time of screening
  • Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgement of the investigator

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Coordinator of this site? Confirm its status
RomaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.