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Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead

NCT03891329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-09-27

Study results available
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Summary

Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.

Conditions

Interventions

DEVICE

Acticor/Rivacor ICDs/CRT-Ds

pre-defined device programming, measurements and follow-up schedule

DEVICE

Plexa S DX

Implantation, measurements and follow-up schedule

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Jan Steffel, MD · Universitätsspital Zürich

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-12-21
Completion
2021-09-24

Countries

  • Austria
  • Germany
  • Hungary
  • Latvia
  • Netherlands
  • Slovakia
  • Switzerland

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 NCT03891329 on ClinicalTrials.gov