MedTrace Logo

Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System

NCT04870281 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2022-01-28

No results posted yet for this study

Summary

The purpose of the BIO-AffectDX Study is to prospectively evaluate improvement from baseline in heart failure subjects with atrial fibrillation (AF) implanted with a two-lead CRT-DX system, with emphasis on a comparison of patient outcomes between AF subtypes.

Conditions

Interventions

DEVICE

CRT-DX

Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexandru Costea, MD · University of Cincinnati Heart

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2021-12-29
Completion
2021-12-29
FDA Device
Yes

Countries

  • United States

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 NCT04870281 on ClinicalTrials.gov