Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB (HISalternative)

July 16, 2021 updated by: Michael Vinther, Rigshospitalet, Denmark

Direct HIS-pacing as an Alternative to Biventricular Pacing in Symptomatic Heart Failure Patients With Severely Reduced LVEF and a True Left Bundle Branch Block

The present study will randomize 50 symptomatic heart failure patients with severely reduced left ventricular ejection fraction (LVEF) and a true left bundle branch block to either direct HIS-pacing or biventricular pacing and follow them for at least six months. The outcome is how often it is possible to achieve HIS-pacing at implant and during follow-up and if HIS-pacing leads to differences in symptoms or measurable clinical parameters as compared to biventricular pacing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Biventricular (BiV) pacing is an established treatment of symptomatic heart failure patients with severely reduced left ventricular ejection fraction (HFrEF) and wide QRS due to bundle branch block (BBB) on a 12-lead ECG. BiV pacing is normally achieved with an endocardial pacing lead in the right ventricle and an epicardial lead over the left ventricle situated in a coronary vein. BiV pacing does not correct the BBB but corrects the mechanical dyssynchrony that is a consequence of the BBB. It has been shown to work best on patients with "true" left bundle branch block (LBBB) where the block is due to disease within the conduction system (and not for example left ventricular hypertrophy or scars). Even if the patient is an ideal candidate for BiV pacing it can sometimes be difficult to achieve the best mechanical resynchronization because of anatomic difficulties, high pacing thresholds or phrenic nerve capture.

In recent years it has been demonstrated that the level of block in true LBBB is often within the bundle of HIS and it is possible in many cases to place a pacing lead distally to the site of block and get capture of both right and left bundles thereby "correcting" the BBB and achieve a normal or near-normal QRS complex. If the conduction system is intact distal to the block this mode of pacing leads to complete resynchronization of the ventricles. HIS-pacing can be achieved as either selective HIS-capture where it is only the conduction system that is paced leading to a narrow QRS complex. However, mostly it is achieved with non-selective HIS-capture where both the septal myocardium close to the pacing site and the His-bundle is captured. This leads to a QRS resembling the QRS achieved by selective HIS-capture but preceded by a delta-wave-like deflection which broadens the QRS complex. Since it is only a small part of the septum that is captured early this does not influence the resynchronization of the heart. In some patients HIS-pacing cannot be achieved due to anatomical difficulties that hinders reaching the HIS bundle with the present tools available. In others it is not possible to come distal to the block and recruiting both the left and the right bundle branch.

There is to date no randomized studies between HIS-bundle pacing and BiV pacing in HFrEF patients with LBBB but there are several case reports and retrospective data on successful HIS-bundle pacing in these patients. The present study will randomize 50 patients in a single centre to HIS-pacing or BiV pacing to determine to which extent it is possible to achieve normalization or near-normalization of the QRS with HIS-bundle pacing and what this translates to with regard to symptom relieve, walking distance, echocardiographic measures and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels as compared to BiV pacing.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Patients with ischaemic or non-ischaemic cardiomyopathy
  • LVEF ≤ 35 % as assessed by echocardiography
  • New York Heart Association (NYHA) class II-IV despite optimal medical therapy
  • Either found eligible for cardiac resynchronization therapy (CRT-P or CRT-D) because of sinus rhythm and "true" LBBB according to Strauss criteria on a 12-lead ECG
  • or found eligible for upgrade of an existing pacing system to cardiac resynchronization therapy (CRT-P or CRT-D) because of sinus rhythm and "true" LBBB according to Strauss criteria on a 12-lead ECG or at least 90 % right ventricular pacing in the preceding two months.
  • Signed informed consent

Exclusion Criteria:

  • Existing biventricular pacing system
  • Permanent atrial fibrillation
  • Severe kidney failure (eGFR < 30 ml/min)
  • Acute myocardial infarction or Coronary By-pass Grafting within the preceding three months
  • unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct HIS-pacing
In this arm a right ventricular (RV) lead or implantable cardioverter defibrillator (ICD) lead is placed first and then implantation of a HIS-pacing lead is attempted. If it is not possible to find and pace HIS or it is not possible to correct the LBBB, a left ventricular (LV) lead is implanted instead.
Procedure: Implantation of a HIS-pacing lead
This intervention is attempted first
Active Comparator: Biventricular pacing
In this arm an RV-lead or ICD-lead is placed first and then implantation of a LV-pacing lead is attempted. If this is not possible due to anatomical difficulties (no coronary sinus (CS) access, no available branches other than v cordis anterior or v cordis media) or electrical difficulties (no capture below 4 V at 1.0 msec or phrenic nerve stimulation < 2x pacing threshold)
Procedure: Implantation of a LV-pacing lead
This intervention is attempted first

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of obtaining capture of HIS-bundle with narrowing of the QRS-duration
Time Frame: 6 months
What is the success rate of implanting a pacing lead to the HIS bundle with narrowing of the QRS duration and maintaining this effect during the course of the study
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall in end-systolic volume > 15%
Time Frame: 6 months
How many HIS-paced patients as opposed to BiV paced patients have a fall in end-systolic volume > 15 % of the initial value?
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2018

Primary Completion (Actual)

November 10, 2020

Study Completion (Actual)

December 10, 2020

Study Registration Dates

First Submitted

July 29, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIS-alternative

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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