Status:
TERMINATED
Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure
Lead Sponsor:
Region Skane
Conditions:
Heart Failure, Systolic
Left Bundle Branch Block
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for patients with low ejection fraction and persistent symptoms of heart failure despite medical therapy and a wide...
Detailed Description
Primary hypothesis: His-bundle pacing will lead to a better stroke volume at rest compared to biventricular pacing. Primary outcome measure: Stroke-volume (ml) at rest assessed by invasive hemodyna...
Eligibility Criteria
Inclusion
- Age \>18 years
- Native QRS-duration \>130 ms and a left bundle branch block or previous His-ablation
- Heart failure in New York Heart Association functional class II-IV
- Echocardiographic non-responder to ongoing CRT defined as \<15% reduction in LVESV compared to pre-CRT examination
- Clinical non-responder to ongoing CRT, defined as lack of subjective improvement after CRT
- Signed informed consent
Exclusion
- Known access site problems in vena jugularis interna dx or sin
- Not able to perform supine cycling
- Presence of severe tricuspid regurgitation
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04701112
Start Date
September 1 2021
End Date
February 27 2025
Last Update
February 28 2025
Active Locations (1)
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1
Skane University Hospital
Lund, Sweden