His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• AV block II or III with high expected pacing need
• Left ventricular ejection fraction between 40% and 55% (inclusive)
• Willing to participate and sign informed consent
Locations
Other Locations
Sweden
Skane University Hospital
RECRUITING
Lund
Norrland University Hospital
RECRUITING
Umeå
Region Hallands Sjukhus Varberg
RECRUITING
Varberg
Contact Information
Primary
Maiwand Farouq, MD, PhD
maiwand.farouq@skane.se
+ 46 40 336415
Backup
Rasmus Borgquist, MD
rasmus.borgquist@med.lu.se
+46 46 171010
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 40
Treatments
Experimental: His-bundle pacing first
Patients are allocated to receive His-bundle pacing for a period of 6 months. Then the patients will cross over to traditional right ventricular (RV) apical pacing for 6 months.
Experimental: RV apical pacing first
Patients are allocated to receive traditional RV apical pacing for a period of 6 months. Then the patients will cross over to His-bundle pacing for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Region Skane