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

Heart Failure Clinical Trial

— BIO-AffectDX  

Official title:

BIO-AffectDX Clinical Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04870281
• Other study ID #: BIO-AffectDX
• Status: Terminated
• Start date: May 28, 2021
• Est. completion date: December 29, 2021

Study information

• Verified date: January 2022
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 29, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

Device:
• CRT-DX
Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Composite Score from baseline		12 months
Secondary	Rate of composite all-cause death and heart failure		12 months
Secondary	Change in quality of life questionnaires from baseline for all patients and by atrial fibrillation sub-type		6 and 12 months
Secondary	Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type		6 and 12 months
Secondary	Change in six-minute walk distance from baseline for all patients and by atrial fibrillation sub-type		6 and 12 months
Secondary	Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type		6 and 12 months
Secondary	Change in Clinical Composite Score from baseline		6 months
Secondary	Rate of major complications		12 months
Secondary	Rate of conversion to sinus rhythm		12 months