Clinical trial NCT03452462: Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing
Official title: Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Pacing, Artificial
Cardiac Resynchronization Therapy
Direct His Bundle Pacing
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Fund for Scientific Research
First posted: 2018-03-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The study will be a randomized crossover design with acute measurements.

Detailed description: By recruiting native conducting tissue to relay electrical activation of the ventricles via the Purkinje fibre network, DHBP may potentially achieve greater electrical resynchronization and hemodynamic benefit compared to BiV where the electrical activation wavefronts propagate from two discrete pacing sites. Electrical synchrony achieved by these pacing modes have however never been compared. Furthermore, the acute hemodynamic effect of DHBP has been compared to BiV only in a small single study to date. The aims are to compare DHBP with BiV in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The primary endpoint will be left ventricular activation time, with secondary endpoints including various electrical (right ventricular activation time, total ventricular activation time etc) and hemodynamic parameters (systolic pressure, cardiac output, cardiac contractility). It is expected that DHBP offers shorter left ventricular activation time (i.e. better synchrony) and hemodynamic benefit compared to BiV.

Eligibility criteria: Inclusion Criteria:

* Treatment of heart failure with a standard indication for CRT (NYHA III-IV, LVEF \< 35% and QRS \> 130ms; or LVEF\< 40% and requirement for frequent ventricular pacing, irrespective of baseline QRS duration) and optimal medical treatment.

  * Permanent atrial fibrillation (allowing connection of the DHBP lead to the atrial port).
  * Patients implanted with 1) a CRT pacemaker or CRT defibrillator 2) a His lead with selective or non-selective DHBP, connected to the atrial port of the generator 3) a functional right ventricular lead and 4) a functional coronary sinus lead.
  * DHBP with selective or non-selective His capture

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Inability to undergo CT or an MRI (e.g. due to severe claustrophobia)
* Inability or refusal to sign the patient informed consent form.

Primary outcomes:
measure: Left ventricular activation time
timeFrame: 5 minutes
Secondary outcomes:
measure: Right ventricular activation time
timeFrame: 5 minutes
measure: Total ventricular activation time
timeFrame: 5 minutes
measure: Systolic pressure
timeFrame: 5 minutes
measure: Cardiac output
timeFrame: 5 minutes
measure: Cardiac contractility
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
state: GE
Study officials:
References:
citation: Zweerink A, Zubarev S, Bakelants E, Potyagaylo D, Stettler C, Chmelevsky M, Lozeron ED, Hachulla AL, Vallee JP, Burri H. His-Optimized Cardiac Resynchronization Therapy With Ventricular Fusion Pacing for Electrical Resynchronization in Heart Failure. JACC Clin Electrophysiol. 2021 Jul;7(7):881-892. doi: 10.1016/j.jacep.2020.11.029. Epub 2021 Feb 24.