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

Study Overview
=================
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.

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.

Official Title
-----------------
BIO-AffectDX Clinical Study

Conditions
-----------------
Heart Failure, Atrial Fibrillation, Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Device: CRT-DX


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRT-DX System<br> | Device: CRT-DX<br>* Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Composite Score from baseline |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in Clinical Composite Score from baseline |  | 6 months | 
| Rate of major complications |  | 12 months | 
| Rate of conversion to sinus rhythm |  | 12 months |