His Pacing Feasibility and Cardiac Electrical Activation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; AV Block; Pacing-Induced Cardiomyopathy
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna M Thøgersen, MD DMSc; Phone Number: +4597664427; Email: anmat@rn.dk
• Study Contact Backup: Name: Jacob M Larsen, MD PhD; Phone Number: +4597664456; Email: jaml@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: His Pacing; Implant of a supplementary His pacing lead in addition to a traditional RV pacing lead.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of chronic His pacing success	Chronic His capture with clinically acceptable pacing threshold (<=3.5V)	Evaluated at 1 year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
QRS duration (ms)	Comparing His pacing and RV pacing	Implantation to 1 year follow up
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
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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Study Director: Sam Riahi, MD PhD, Aalborg University Hospital; Study Director: Peter Søgaard, MD DMSc, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: N-20200032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes