NCT04870281

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

BIO-AffectDX Clinical Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Biotronik, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is a need for more evidence about the benefits of Cardiac Resynchronization Therapy (CRT) in a patient population with heart failure and atrial fibrillation. The BIO-AffectDX Study will gather information about adults with heart failure and atrial fibrillation who are treated with a CRT-DX device from many locations across the United States. The BIO-AffectDX Study will look at the results of treatment in participants with the primary goal to evaluate the improvement in overall health prior to device implant through 12 months. Overall health will be measured by your study doctor for AF improvement, physical fitness, and general quality of life.

Conditions

• Heart Failure
• Atrial Fibrillation
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	CRT-DX	Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.

Timeline

• Start date: 2021-05-28
• Primary completion: 2021-12-29
• Completion: 2021-12-29
• First posted: 2021-05-03
• Last updated: 2022-01-28

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study