High-risk coronary intervention with a heart pump
Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
This study tests whether a heart pump can help people with severe heart problems have safer and more successful procedures like stent placements.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05003817 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a percutaneous left ventricular unloading device during coronary interventions for patients at high risk of heart failure. The device is inserted through a blood vessel in the leg and supports the heart's pumping function during procedures like stent placements. The study aims to assess the safety and efficacy of this technology in patients with severe coronary artery disease and left ventricular dysfunction. By providing additional support to the heart, the trial seeks to reduce the risk of complications during high-risk cardiac procedures.
Who should consider this trial
Good fit: Ideal candidates include patients with extensive coronary disease and severe left ventricular dysfunction who are undergoing complex percutaneous coronary interventions.
Not a fit: Patients with mild coronary artery disease or those without significant left ventricular dysfunction may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of heart failure and improve outcomes for patients undergoing high-risk coronary interventions.
How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8\*
2. Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)#
3. Complex PCI defined by the presence of at least one of the following criteria:
* Unprotected left main intervention in the presence of
* an occluded dominant right coronary artery, or
* a left dominant circulation, or
* disease involving the entire bifurcation (Medina1,1,1 or 0,1,1)
* Intended calcium modification (by rotational or orbital atherectomy, lithotripsy or laser)
* in multiple vessels or
* in the left main stem, or
* in a final patent conduit, or
* where the anatomic SYNTAX score is ≥32
* Target vessel is a chronic total occlusion with planned retrograde approach \* In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium.
* Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF.
Exclusion Criteria:
1. Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device)
2. Contraindication to pLVAD insertion
3. Inability to give informed consent
4. Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes
Where this trial is running
London
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Divaka Perera — Kcl, Gstt
- Study coordinator: Trial Manager
- Email: CHIP-BCIS3@LSHTM.ac.uk
- Phone: 020 7927 2723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.