GREEN CATHeter Lab Study

NCT07106437 | Completed

• 1 other identifier: kt25Boeddinghaus2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves the prospective quantification and classification of waste produced during interventional cardiology procedures. For each included case, the total waste generated will be measured in kilograms immediately after completion of the procedure. Waste will be physically sorted and recorded by category in accordance with four predefined waste types: (i) paper and cardboard, (ii) regular waste (i.e., municipal solid waste or general trash), (iii) regulated medical waste (requiring specialized incineration including sharpsafe), and (iv) recyclable plastic. Based on two models ("Basel Model" and "Standard Model"), the study will perform scenario-based calculations to compare the environmental and economic impact of both strategies.

Conditions

Waste, Medical; Waste, Procedural

Keywords

ecological footprint; Interventional cardiology procedures; environmental impact; CO₂ emissions; disposal costs; ReCiPe endpoint method; life cycle impact assessment

Outcome Measures

Primary Outcomes (4)

• Total amount of waste (kilogram) generated per cardiac intervention- procedure type

  The waste will be weighed using a certified, hospital-grade scale provided by the in-house hospital pharmacy (Beurer, Typ KS 59, max 20 kg).

  one time assessment immediately after cardiac intervention

• Composition of waste (by waste category) generated per cardiac intervention- procedure type

  Waste will be physically sorted and recorded by category in accordance with four predefined waste types: (i) paper and cardboard, (ii) regular waste (i.e., municipal solid waste or general trash), (iii) regulated medical waste (requiring specialized incineration including sharpsafe), and (iv) recyclable plastic.

  one time assessment immediately after cardiac intervention

• Relation of waste output to the average daily waste production of a Swiss resident (in kilogram)

  Relation of waste output generated per cardiac intervention- procedure type to the average daily waste production of a Swiss resident (in kilogram)

  one time assessment immediately after cardiac intervention

• Relation of waste output to the average daily waste production of a typical inhospital patient (in kilogram)

  Relation of waste output generated per cardiac intervention- procedure type to the average daily waste production of a typical inhospital patient (in kilogram)

  one time assessment immediately after cardiac intervention

Secondary Outcomes (3)

• Comparison of environmental impact by CO₂ emissions

  Postprocedural (one time assessment after cardiac intervention)

• Comparison of environmental impact by disposal costs (in Swiss Francs)

  Postprocedural (one time assessment after cardiac intervention)

• Ecological burden by ReCiPe score

  Postprocedural (one time assessment after cardiac intervention)

Study Arms (4)

Elective diagnostic coronary angiography

Elective diagnostic coronary angiography with or without simple PCI

Other: "Basel Model": Measure of total waste after completion of the procedure; Other: "Standard Model": Measure of total waste after completion of the procedure

Complex percutaneous coronary interventions (PCI) procedures

Complex PCI procedures, including CTO, CHIP, or patients in cardiogenic shock requiring temporary mechanical circulatory support with an Impella device

Other: "Basel Model": Measure of total waste after completion of the procedure; Other: "Standard Model": Measure of total waste after completion of the procedure

Structural heart intervention: transcatheter aortic valve implantation (TAVI)

Structural heart intervention: TAVI

Other: "Basel Model": Measure of total waste after completion of the procedure; Other: "Standard Model": Measure of total waste after completion of the procedure

Structural heart interventions: transcatheter edge-to-edge repair (TEER)

Structural heart interventions: TEER of the mitral or tricuspid valves (MitraClip or TriClip systems)

Other: "Basel Model": Measure of total waste after completion of the procedure; Other: "Standard Model": Measure of total waste after completion of the procedure

Interventions

"Basel Model": Measure of total waste after completion of the procedure OTHER

For each included case, the total waste generated will be measured in kilograms immediately after completion of the procedure and physically recorded by category in accordance with four predefined waste types: (i) paper and cardboard, (ii) regular waste (i.e., municipal solid waste or general trash), (iii) regulated medical waste (requiring specialized incineration including sharpsafe), and (iv) recyclable plastic

Complex percutaneous coronary interventions (PCI) procedures; Elective diagnostic coronary angiography; Structural heart intervention: transcatheter aortic valve implantation (TAVI); Structural heart interventions: transcatheter edge-to-edge repair (TEER)

"Standard Model": Measure of total waste after completion of the procedure OTHER

Simulation of a hypothetical but common practice in many hospitals, in which all waste generated during interventional procedures is disposed of as regulated medical waste, without separation.

Complex percutaneous coronary interventions (PCI) procedures; Elective diagnostic coronary angiography; Structural heart intervention: transcatheter aortic valve implantation (TAVI); Structural heart interventions: transcatheter edge-to-edge repair (TEER)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study "population" includes the following interventional procedures on scheduled audit days: (i) elective diagnostic coronary angiography with or without simple PCI, (ii) complex PCI procedures, including CTO, CHIP, or patients in cardiogenic shock requiring temporary mechanical circulatory support with an Impella device, (iii) TAVI, and (iv) TEER of the mitral or tricuspid valves, such as with MitraClip or TriClip systems. A minimum of ten cases per procedure type will be targeted to ensure adequate comparisons. All patients undergoing the above-listed procedures during the defined measurement days are eligible for inclusion

You may qualify if:

• All patients undergoing the following interventional procedures:
• o Elective diagnostic coronary angiography
• with PCI
• without PCI
• Complex percutaneous coronary interventions (CTO, CHIP, or patients with cardiogenic shock requiring Impella support)
• Structural heart intervention: TAVI
• Structural heart interventions: TEER of the mitral or tricuspid valve (MitraClip or TriClip)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Cardiology, University Heart Center Basel, University Hospital Basel

Basel, 4031, Switzerland

Location

Study Officials

• Jasper Boeddinghaus, PD Dr. med.

  Department of Cardiology, University Heart Center Basel, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start: May 1, 2025
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CH (1)