His Pacing Feasibility and Cardiac Electrical Activation
His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
This study will examine the clinical feasibility of His pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. Secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and His pacing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFebruary 4, 2021
February 1, 2021
2.9 years
January 19, 2021
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of chronic His pacing success
Chronic His capture with clinically acceptable pacing threshold (\<=3.5V)
Evaluated at 1 year follow up
Secondary Outcomes (4)
Rate of perioperative His pacing success
The implant procedure duration i.e. incision to skin closure
QRS duration (ms)
Implantation to 1 year follow up
Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters
Implant to 1 year follow up
Changes in regional right and left ventricular electrical activation delay
Implant to 1 year follow up
Study Arms (1)
His Pacing
EXPERIMENTALImplant of a supplementary His pacing lead in addition to a traditional RV pacing lead.
Interventions
The patients will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port.
Eligibility Criteria
You may qualify if:
- Permanent pacemaker indication with expected high demand of right ventricular pacing (\>40%) and left ventricular ejection fraction \>40%.
You may not qualify if:
- No class I indication for CRT pacemaker (HRS 2018 Pacing Guidelines)
- Hemodynamically unstable patients
- Severely reduced kidney function
- Former serious adverse reactions to contrast media
- Pregnant or lactating
- Severe psychiatric disorder which can compromise compliance with protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sam Riahi, MD PhD
Aalborg University Hospital
- STUDY DIRECTOR
Peter Søgaard, MD DMSc
Aalborg University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
January 19, 2021
First Posted
February 4, 2021
Study Start
February 15, 2021
Primary Completion
January 1, 2024
Study Completion
January 1, 2024
Last Updated
February 4, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share