Clinical trial NCT04739553: His Pacing Feasibility and Cardiac Electrical Activation
Official title: His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacing-Induced Cardiomyopathy
AV Block
Heart Failure
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: After being informed about the study and potential risks, all eligible patients giving written consent will be included. The study is a clinical single-center interventional study. The patients (n = 25) need to have an expected high demand for ventricular pacing and no established class I indication for cardiac resynchronization therapy. They 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. Postoperatively, the baseline examinations will include: transthoracic echocardiography, 12-lead ECG with a 3D photography of the chest wall to document ECG electrode location, and a contrast-enhanced cardiac CT scan. The echocardiography and ECG will be performed during traditional right ventricular pacing only and His pacing only. His pacing will be used as the permanent programming of choice if feasible during follow up. The CT scan is used for documenting the final positions of the pacing leads and to create a patient-specific 3D model of the cardiac electrical activation using a software which enables merging of a CT scan and ECG and a CT chest photography. During follow up (1-3 and 12 months), transthoracic echocardiography, 12-lead ECG and 3D chest photography are repeated for assessment of mechanical and electrical function during pacing. The performance of all implanted pacing lead will be evaluated at each follow up visit.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of chronic His pacing success
timeFrame: Evaluated at 1 year follow up
Secondary outcomes:
measure: Rate of perioperative His pacing success
timeFrame: The implant procedure duration i.e. incision to skin closure
measure: QRS duration (ms)
timeFrame: Implantation to 1 year follow up
measure: Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters
timeFrame: Implant to 1 year follow up
measure: Changes in regional right and left ventricular electrical activation delay
timeFrame: Implant to 1 year follow up
Other outcomes:
Locations:
Study officials:
affiliation: Aalborg University Hospital
name: Sam Riahi, MD PhD
role: STUDY_DIRECTOR
affiliation: Aalborg University Hospital
name: Peter Søgaard, MD DMSc
role: STUDY_DIRECTOR
References: