NCT03839121

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

BIO|REDUCE: Cardiac REsynchronization Therapy With Two Ventricular Leads and Right Atrial Floating Diagnostic Dipole Installed in the Right ventricUlar Lead in Patients With CRT-D indiCation and no Sinus nodE Dysfunction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Heart Failure
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	Cardiac Resynchronization Therapy (CRT)	Observation and documentation of CRT patients

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2019-02-15
• Last updated: 2025-04-09

Locations

21 sites across 4 countries: Austria, Czechia, Germany, Hungary