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

Stopped early

Conditions studied: Heart Failure, Atrial Fibrillation, Cardiac Resynchronization Therapy

In brief

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.

Key facts

Study ID

NCT04870281

Run by

Biotronik, Inc.

People needed

13

Starts

2021-05-28

Expected to finish

2021-12-29

Last updated by the study team

2022-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Standard CRT-D indication according to current guidelines
• Patient has documented history of paroxysmal, persistent, or long-standing persistent atrial fibrillation
• De novo implant or upgrade from a DX implantable cardioverter-defibrillator (ICD) system
• Implant planned to occur within 30 days of consent
• Patient is able to understand English or Spanish
• Patient is able to understand the nature of the study and provide informed consent
• Patient is willing and able to complete all routine study visits at the investigational site for up to 12 months of follow-up
• Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
• Patient age is greater than or equal to 18 years
• After consent has been signed, additional inclusion criteria must be fulfilled for study participation:
• Baseline subject assessment is evaluated as New York Heart Association class II, III or ambulatory IV heart failure at study Enrollment Visit
• Baseline subject assessment of six-minute walk test is completed at study Enrollment Visit and walk distance ≤ 450 meters (1,476 feet)

You may not qualify if…

• Contraindication to CRT-D/CRT-DX
• Patient has current or previous atrial pacing need
• Patient is considered for a His Bundle Pacing system
• Patient has current or previous pacemaker, non-DX ICD implant, or bi-ventricular pacing system prior to enrolling
• Patient is currently planned for a pulmonary vein isolation catheter ablation procedure within 3 months of consent
• Patient life expectancy is less than 1 year
• Patient is expected to receive heart transplantation or ventricular assist device within 1 year after implant
• Patient is expected to have a cardiac surgical procedure, such as coronary artery bypass graft or valve transcatheter replacement/repair or surgery, planned to occur within 6-months after implant (excludes atrioventricular node ablation procedures)
• Patient is currently on dialysis, or is expected to receive dialysis within 1 year of implant
• Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
• Any condition (e.g. severe arthritis, wheelchair bound, etc.) preventing the patient from performing the required six-minute walk test
• Conditions that prohibit placement of any of the system leads
• Patient reports pregnancy at the time of consent

Where it is running

• University of California San Diego - La Jolla — La Jolla, California, United States
• Cardiology Associates Medical Group — Ventura, California, United States
• Orlando Health Heart Institute — Orlando, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• University of Kentucky - Gill Heart and Vascular Institute — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Cardiology Associates of North Mississippi — Tupelo, Mississippi, United States
• Mercy Hospital Springfield — Springfield, Missouri, United States
• Glacier View Research Institute Cardiology — Kalispell, Montana, United States
• Weill Cornell Medicine — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Heart Rhythm Associates — Greenville, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• ProMedica Northwest Ohio Cardiology Consultants — Toledo, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Upstate Cardiology — Greenville, South Carolina, United States
• Erlanger Institute for Clinical Research — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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