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Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm

NCT03839121 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2025-04-09

No results posted yet for this study

Summary

The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO\|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.

Conditions

Interventions

DEVICE

Cardiac Resynchronization Therapy (CRT)

Observation and documentation of CRT patients

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Christof Kolb, Prof. · DHM, München

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-06-08
Completion
2023-06-08

Countries

  • Austria
  • Czechia
  • Germany
  • Hungary

Study Locations

More Related Trials

Entities

Diseases

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 NCT03839121 on ClinicalTrials.gov