NCT03614169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

July 29, 2018

Last Update Submit

July 16, 2021

Conditions

Heart Failure With Reduced Ejection FractionLeft Bundle-Branch Block

Keywords

HIS-pacingBiventricular pacing

Outcome Measures

Primary Outcomes (1)

  • Success rate of obtaining capture of HIS-bundle with narrowing of the QRS-duration

    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 Outcomes (1)

  • Fall in end-systolic volume > 15%

    6 months

Study Arms (2)

Direct HIS-pacing

EXPERIMENTAL

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

Biventricular pacing

ACTIVE COMPARATOR

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

Interventions

Implantation of a HIS-pacing leadPROCEDURE

This intervention is attempted first

Direct HIS-pacing
Implantation of a LV-pacing leadPROCEDURE

This intervention is attempted first

Biventricular pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Related Publications (1)

  • Vinther M, Risum N, Svendsen JH, Mogelvang R, Philbert BT. A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block (His-Alternative). JACC Clin Electrophysiol. 2021 Nov;7(11):1422-1432. doi: 10.1016/j.jacep.2021.04.003. Epub 2021 Apr 25.

    PMID: 34167929RESULT

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2018

First Posted

August 3, 2018

Study Start

September 9, 2018

Primary Completion

November 10, 2020

Study Completion

December 10, 2020

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

DK(1)