Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses

NCT ID: NCT04379453

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2020-04-27

Brief Summary

Percutaneous cardiovascular intervention procedures (e.g. coronary angioplasty, peripheral artery angioplasty) must be performed in person, requiring the physical presence of one or more medical, nursing and technical professionals. The control of catheters and interventional materials is performed manually, with the operator positioned next to the patient. This context results in potential for reciprocal exposure to exhaled air, both for the professionals involved and for the patient, with an inherent risk of aerial contamination. It is important to note that interventional procedures are often performed on an urgent or emergency basis (e.g. myocardial infarction), without the possibility of postponement or postponement.

The recent robot-assisted cardiovascular intervention makes it possible to modify this scenario by allowing the procedure to be performed effectively and safely in a position far from the patient. In an environment with high potential for contamination, mainly related to the current pandemic caused by the COVID-19 virus, may prove to be a tactic to expand hospital security.

It is in this sense that the present pilot proposal is inserted, which, ultimately, aims to evaluate the potential of robotic intervention as a strategy to reduce exposure to exhaled air of patients and professionals during the intervention procedure.

Detailed Description

Percutaneous cardiovascular intervention procedures (e.g. coronary angioplasty, peripheral artery angioplasty) must be performed in person, requiring the physical presence of one or more medical, nursing and technical professionals. The control of catheters and interventional materials is performed manually, with the operator positioned next to the patient. This context results in potential for reciprocal exposure to exhaled air, both for the professionals involved and for the patient, with an inherent risk of aerial contamination. It is important to note that interventional procedures are often performed on an urgent or emergency basis (e.g. myocardial infarction), without the possibility of postponement or postponement.

The recent robot-assisted cardiovascular intervention makes it possible to modify this scenario by allowing the procedure to be performed effectively and safely in a position far from the patient. In an environment with high potential for contamination, mainly related to the current pandemic caused by the COVID-19 virus, may prove to be a tactic to expand hospital security.

It is in this sense that the present pilot proposal is inserted, which, ultimately, aims to evaluate the potential of robotic intervention as a strategy to reduce exposure to exhaled air of patients and professionals during the intervention procedure.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot Assisted Percutaneous Cardiovascular Intervention

Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses

Group Type: EXPERIMENTAL

Robot Assisted Percutaneous Cardiovascular Intervention

Intervention Type: PROCEDURE

Robot Assisted Percutaneous Cardiovascular Intervention

Interventions

Robot Assisted Percutaneous Cardiovascular Intervention

Robot Assisted Percutaneous Cardiovascular Intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age> = 18 years;
• Cardiovascular disease characterized by:
• Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions OR
• Symptomatic peripheral arterial disease and / or with objective evidence of the need for percutaneous intervention of one or more target lesions;
• The target lesion (s) must be obstructive and / or aneurysmatic (visual analysis);
• Interventionist planning for all target lesions should include robotic manipulation in at least one treatment period, according to the operator's judgment;
• The patient will be informed about the nature of the study, agree with its rules and will provide written informed consent, approved by the local Ethics Committee.

Exclusion Criteria

• Platelet count <50,000 cells / mm3 or> 700,000 cells / mm3;
• Total leukometry <3,000 cells / mm3;
• Suspected or documented active liver disease, with blood dyscrasia with INR <1.5;
• Heart transplant recipient;
• Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel;
• Patient with a life expectancy of less than 1 month;
• Any significant medical condition that in the investigator's opinion may interfere with the patient's ideal participation in this study;
• Participation in another research in the last 12 months, unless there can be direct benefit to the research subject;
• Any invasive cardiac or non-cardiac treatment scheduled in the first month after the index procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Lemos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Pedro Lemos, MD

Role: CONTACT

pedro.lemos@einstein.br

+55 (11)98317-5000

Facility Contacts

Pedro A Lemos, MD

Role: primary

pedro.lemos@einstein.br

+55 (11) 2151-0449

References

Lemos PA, Franken M, Mariani J Jr, Pitta FG, Oliveira FA, Cunha-Lima G, Caixeta AM, Almeida BO, Garcia RG. Use of robotic assistance to reduce proximity and air-sharing during percutaneous cardiovascular intervention. Future Cardiol. 2021 Aug;17(5):865-873. doi: 10.2217/fca-2021-0024. Epub 2021 Apr 9.

Reference Type: DERIVED

PMID: 33834847 (View on PubMed)

Other Identifiers

4094-20

Identifier Type: -

Identifier Source: org_study_id