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

No results posted yet for this study

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

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
  • King's College London

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084467 on ClinicalTrials.gov