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His Pacing Feasibility and Cardiac Electrical Activation

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ClinicalTrials.gov Identifier: NCT04739553
Recruitment Status : Not yet recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Anna Margrethe Thoegersen, Aalborg University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pacing-Induced Cardiomyopathy AV Block Heart Failure Device: His Pacing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of chronic His pacing success [ Time Frame: Evaluated at 1 year follow up ]
    Chronic His capture with clinically acceptable pacing threshold (<=3.5V)


Secondary Outcome Measures :
  1. Rate of perioperative His pacing success [ Time Frame: The implant procedure duration i.e. incision to skin closure ]
    Perioperative his capture with clinically acceptable pacing threshold (<=3.5V)

  2. QRS duration (ms) [ Time Frame: Implantation to 1 year follow up ]
    Comparing His pacing and RV pacing

  3. Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters [ Time Frame: Implant to 1 year follow up ]
    Comparing left ventricular mechanical dyssynchrony during His pacing and RV pacing using echocardiographic two-dimensional longitudinal strain

  4. Changes in regional right and left ventricular electrical activation delay [ Time Frame: Implant to 1 year follow up ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739553


Contacts
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Contact: Anna M Thøgersen, MD DMSc +4597664427 anmat@rn.dk
Contact: Jacob M Larsen, MD PhD +4597664456 jaml@rn.dk

Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Study Director: Sam Riahi, MD PhD Aalborg University Hospital
Study Director: Peter Søgaard, MD DMSc Aalborg University Hospital
More Information
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Responsible Party: Anna Margrethe Thoegersen, Medical Doctor, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04739553    
Other Study ID Numbers: N-20200032
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases