His Pacing Feasibility and Cardiac Electrical Activation

Heart Failure Clinical Trial

Official title:

His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04739553
• Other study ID #: N-20200032
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: January 2024

Study information

• Verified date: February 2021
• Source: Aalborg University Hospital
• Contact: Anna M Thøgersen, MD DMSc
• Phone: +4597664427
• Email: anmat[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• AV Block
• Cardiomyopathies
• Heart Failure
• Pacing-Induced Cardiomyopathy

Intervention

Device:
• His Pacing
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Outcome

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