Status:
RECRUITING
The Effect of CRT on the Frank Starling Mechanism
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Pacemaker
Heartfailure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators are examining a scientific principle called the Frank Starling Mechanism and how it relates to Cardiac Resynchronisation Therapy (CRT), a form of pacemaker therapy used in the treatm...
Detailed Description
The primary research investigation in this study is a non-invasive test of the Frank Starling mechanism, which involves performing a transthoracic echocardiogram (ultrasound scan of the heart) whilst ...
Eligibility Criteria
Inclusion
- • Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
- Existing dual chamber pacemaker or ICD including atrial lead and RV lead.
- RV pacing percentage \>40%.
- CRT group - Severe left ventricular systolic impairment (LVEF≤35%). Clinical symptoms of heart failure despite optimum medical therapy (NYHA class II-IV).
- Control group - LVEF \>50%.
Exclusion
- • Previous treated with CRT (existing LV lead/His-Bundle lead/Left Bundle Branch Area lead).
- Persistent atrial fibrillation
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Participation in other studies with active treatment / investigational arm
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 2 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05993585
Start Date
January 15 2024
End Date
June 2 2025
Last Update
March 26 2024
Active Locations (1)
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1
Guy's and St Thomas' NHS Trust
London, United Kingdom, SE1 7EH