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

NCT03614169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-07-23

No results posted yet for this study

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.

Conditions

  • Heart Failure With Reduced Ejection Fraction
  • Left Bundle-Branch Block

Interventions

PROCEDURE

Implantation of a HIS-pacing lead

This intervention is attempted first

PROCEDURE

Implantation of a LV-pacing lead

This intervention is attempted first

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-09
Primary Completion
2020-11-10
Completion
2020-12-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614169 on ClinicalTrials.gov