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

NCT04870281 | Terminated FDA Device

• 1 other identifier: BIO-AffectDX
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 23

Brief 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

Heart Failure; Atrial Fibrillation; Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Composite Score from baseline

  12 months

Secondary Outcomes (8)

• Rate of composite all-cause death and heart failure

  12 months

• Change in quality of life questionnaires from baseline for all patients and by atrial fibrillation sub-type

  6 and 12 months

• Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type

  6 and 12 months

• Change in six-minute walk distance from baseline for all patients and by atrial fibrillation sub-type

  6 and 12 months

• Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type

  6 and 12 months

Study Arms (1)

CRT-DX System

Device: CRT-DX

Interventions

CRT-DX DEVICE

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

CRT-DX System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients selected for participation should be from the investigator's general patient population with standard CRT-D indication and according to the inclusion and exclusion criteria.

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
• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (23)

University of California San Diego - La Jolla

La Jolla, California, 92037, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Orlando Health Heart Institute

Orlando, Florida, 38806, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky - Gill Heart and Vascular Institute

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Glacier View Research Institute Cardiology

Kalispell, Montana, 59901, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Heart Rhythm Associates

Greenville, North Carolina, 27834, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

ProMedica Northwest Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Upstate Cardiology

Greenville, South Carolina, 29607, United States

Location

Erlanger Institute for Clinical Research

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandru Costea, MD

  University of Cincinnati Heart

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 3, 2021
• Study Start: May 28, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning no later than 12 months and ending no earlier than 3 years following study closure.
• Access Criteria: Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR 97035; 1-800-547-0394). BIOTRONIK, in consultation with the BIO-AffectDX Steering Committee, will review and evaluate proposals for scientific merit, fiscal feasibility, and logistical feasibility. They will additionally consider if the proposed publication fits into the overall BIO-AffectDX publication plan. If approved, the data requestors will need to sign a data use/access agreement prior to obtaining the data and agree to review and input from the BIO-AffectDX Steering Committee members.

Locations

US (23)