Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing

NCT03452462 | Completed

• 1 other identifier: HisCRT_GVA
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Pacing, Artificial; Cardiac Resynchronization Therapy; Direct His Bundle Pacing

Outcome Measures

Primary Outcomes (1)

• Left ventricular activation time

  Duration of left ventricular electrical activation

  5 minutes

Secondary Outcomes (5)

• Right ventricular activation time

  5 minutes

• Total ventricular activation time

  5 minutes

• Systolic pressure

  5 minutes

• Cardiac output

  5 minutes

• Cardiac contractility

  5 minutes

Study Arms (2)

Direct His Bundle Pacing

EXPERIMENTAL

Pacing from the His bundle lead

Device: Pacing

Biventricular Pacing

ACTIVE COMPARATOR

Pacing from the right ventricular and coronary sinus leads

Device: Pacing

Interventions

Pacing DEVICE

Programming of either Direct His Bundle pacing or biventricular pacing

Biventricular Pacing; Direct His Bundle Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Swiss National Fund for Scientific Research: collaborator

Study Sites (1)

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33640346 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 2, 2018
• Study Start: April 1, 2019
• Primary Completion: August 30, 2020
• Study Completion: November 26, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)