NCT07084467

A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure

Evaluation of First-Phase Ejection Fraction to Guide Cardiac Resynchronization Therapy - A Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiac resynchronization therapy (CRT) is a device treatment for patients with heart failure which cannot be managed by medications alone. CRT can help the heart contract more efficiently and improve the pumping function. However, many patients do not benefit from this treatment. Therefore, a better selection tool will help us to determine the most suitable patients to receive this treatment. A new measure of pumping function of the heart called: first-phase ejection fraction or EF1 has been shown a good tool to select suitable patients for CRT. EF1 is a sensitive measurement of heart function and can be easily measured by echocardiography (an ultrasound heart scan). The purpose of this study is to examine whether this new measurement (EF1) can predict outcomes and response to CRT treatment.

Conditions

• Cardiac Resynchronisation Therapy (CRT)
• Heart Failure

Interventions

Type	Name	Description
OTHER	EF1 guided CRT optimisation	In the EF1-guided optimisation group, the settings of the CRT device are adjusted to maximise early heart pumping efficiency, measured by a parameter called first-phase ejection fraction (EF1). Depending on the patient's heart rhythm, either the timing between heart chambers (AV or VV delay) is adjusted in small steps. The device setting that gives the best EF1 reading is chosen to help improve the heart's response to CRT.
OTHER	Standard of Care (SOC)	This group will receive standard of care for their health condition and CRT management.

Timeline

• Start date: 2025-08-01
• Primary completion: 2030-07-31
• Completion: 2030-07-31
• First posted: 2025-07-24
• Last updated: 2025-08-03

Locations

1 site across 1 country: United Kingdom