Heart Failure Clinical Trial
Official title:
His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation
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.
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Permanent pacemaker indication with expected high demand of right ventricular pacing (>40%) and left ventricular ejection fraction >40%. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of chronic His pacing success | Chronic His capture with clinically acceptable pacing threshold (<=3.5V) | Evaluated at 1 year follow up | |
Secondary | Rate of perioperative His pacing success | Perioperative his capture with clinically acceptable pacing threshold (<=3.5V) | The implant procedure duration i.e. incision to skin closure | |
Secondary | QRS duration (ms) | Comparing His pacing and RV pacing | Implantation to 1 year follow up | |
Secondary | Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters | Comparing left ventricular mechanical dyssynchrony during His pacing and RV pacing using echocardiographic two-dimensional longitudinal strain | Implant to 1 year follow up | |
Secondary | Changes in regional right and left ventricular electrical activation delay | Comparing electrical activation pattern during His pacing and RV pacing using non-invasive electroanatomical mapping. This is achieved using software that merges data from a 12-lead electrocardiogram (ECG), chest wall three-dimensional picture of ECG lead positions, and a cardiac computed tomography scan. | Implant to 1 year follow up |
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