Prospective Evaluation for Hybrid Cardiac Procedures (PERHAPS)

August 11, 2025 updated by: Dr. Bruno, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with:

  • Multi-vessel CAD involving the laft main (LM) and/or the left anterior descending (LAD) 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hybrid coronary revascularization strategy (HCR)
Patients who undergo a combination of coronary artery bypass grafting and PCI.
Procedure: Coronary artery bypass grafting
Coronary artery bypass grafting in coronary revascularization.
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention in coronary revascularization.
Hybrid valve and coronary disease correction
Patients who undergo a combination of surgical valve replacement and PCI.
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention in coronary revascularization.
Procedure: Surgical valve replacement
Surgical mitral and / or aortic valve replacement.
Hybrid coronary and carotid artery disease treatment
Patients who undergo a combination of coronary artery bypass grafting and carotid stenting.
Procedure: Coronary artery bypass grafting
Coronary artery bypass grafting in coronary revascularization.
Procedure: Carotid artery stenting
Carotid artery stenting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with stroke
Time Frame: 6 days after operation
Rapid onset of a new neurological deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection) that i) persists beyond 24 hours, or ii) less than 24 hours if: a) associated with infarction or hemorrhage on an imaging study, or b) treated with pharmacologic or mechanical intervention, or c) results in death.
6 days after operation
Number of participants with renal failure
Time Frame: 6 days after operation
Acute or worsening renal failure resulting in one or more of the following: 1. Increase of serum creatinine to ≥ 4.0 with an increase of at least 0.5mg/dl or 3x most recent preoperative creatinine level. 2. A new requirement for dialysis postoperatively.
6 days after operation
Number of participants with prolonged ventilation > 24 hours
Time Frame: 25 hours after operative room exit.
Prolonged postoperative pulmonary ventilation > 24.0 hours.
25 hours after operative room exit.
Number of participants with deep sternal wound infection
Time Frame: Diagnosis within 30 days of the operation or >30 days after procedure but during hospital stay for surgery.
Deep sternal wound infection or mediastinitis (according to Centers for Disease Control (CDC) definition)
Diagnosis within 30 days of the operation or >30 days after procedure but during hospital stay for surgery.
Number of participants who undergo reoperation
Time Frame: 6 days after operation
Reoperation for bleeding/tamponade, valvular dysfunction, graft failure, aortic reintervention, or other cardiac reason.
6 days after operation
Number of participants with major morbidity or operative mortality
Time Frame: 6 days after operation
A composite endpoint defined as any of the outcomes listed in the first six rows of this list
6 days after operation
Number of participants with short stay
Time Frame: 6 days after operation
Patient length of stay < 6 days. Discharged alive and within 5 days of surgery
6 days after operation
Number of participants with long stay
Time Frame: 15 days after operation
Patient length of stay > 14 days. Failure to be discharged within 14 days of surgery
15 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: 30 days post procedure and 12 months
Cardiovascular events include: individual components of major adverse cardiac and cerebrovascular events (MACCE) (all-cause mortality, ischemic stroke, miocardial infarction, unplanned revascularization), ischemia-driven revascularization, cardiovascular and non-cardiovascular mortality, stent thrombosis, symptomatic graft stenosis or occlusion, re-hospitalization and othe medical encounters (all-cause and cardiovascular).
30 days post procedure and 12 months
Bleeding
Time Frame: 30 days post procedure and 12 months
Site assessed bleeding complications will be reported using the Bleeding Academic Research Consortium Scale. This scale ranges from Type 0 bleeding to Type 5 b bleeding. The higher the score is, the worse the outcome is.
30 days post procedure and 12 months
Rate of one or more additional adverse event.
Time Frame: 30 days post procedure and 12 months

Rate of one or more additional adverse event among this list:

  • Acute renal failure or worsening renal function resulting in one or both of the following: increase in serum creatinine by ≥0.5 mg/dL or ≥25% from baseline, or need for dialysis.
  • Atrial fibrillation requiring treatment (including drug therapy, cardioversion or ablation procedures).
  • Major arrhythmia (any supraventricular tachycardia requiring cardioversion, ventricular tachycardia or fibrillation requiring treatment, or bradyarrhythmia requiring temporary or permanent pacemaker).
  • Sternal wound dehiscence.
  • Infection requiring intravenous antibiotics for treatment.
  • Intubation lenght >48 hours.
  • Respiratory failure defined as continued mechanical ventilation required for greater than 48 hours post operatively.
  • Post-pericardiotomy syndrome: an inflammatory response to cardiothoracic surgery.
30 days post procedure and 12 months
Health Status through angina assessment.
Time Frame: 30 days post procedure and 12 months
Angina class measured by the Canadian Cardiovascular Society class. This class ranges from class I to class IV. The higher the class is, the worse the outcome is.
30 days post procedure and 12 months
Health Status through quality of life assessment.
Time Frame: 30 days post procedure and 12 months
Quality of Life will be measured, using the Short Form-12 (SF-12) general health status questionnaire and EuroQoL 5-D (EuroQoL) questionnaire, which measures health state preference from the individual and societal perspective.
30 days post procedure and 12 months
Cost-effectiveness
Time Frame: 12 months post procedure
Overall costs of hospitalization and quality-adjusted life expectancy.
12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Piergiorgio Bruno, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2021

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 20, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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