A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure
NCT07084467 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2025-08-03
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
- 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.
Sponsors & Collaborators
-
Guy's and St Thomas' NHS Foundation Trust
collaborator OTHER -
The Leeds Teaching Hospitals NHS Trust
collaborator OTHER -
King's College Hospital NHS Trust
collaborator OTHER -
Barts Helth NHS Trust
collaborator UNKNOWN - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2030-07-31
- Completion
- 2030-07-31
Countries
- United Kingdom
Study Locations
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