Clinical trial NCT04870281: Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System
Official title: BIO-AffectDX Clinical Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Atrial Fibrillation
Cardiac Resynchronization Therapy
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Clinical Composite Score from baseline
timeFrame: 12 months
Secondary outcomes:
measure: Rate of composite all-cause death and heart failure
timeFrame: 12 months
measure: Change in quality of life questionnaires from baseline for all patients and by atrial fibrillation sub-type
timeFrame: 6 and 12 months
measure: Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type
timeFrame: 6 and 12 months
measure: Change in six-minute walk distance from baseline for all patients and by atrial fibrillation sub-type
timeFrame: 6 and 12 months
measure: Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type
timeFrame: 6 and 12 months
measure: Change in Clinical Composite Score from baseline
timeFrame: 6 months
measure: Rate of major complications
timeFrame: 12 months
measure: Rate of conversion to sinus rhythm
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego - La Jolla
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Orlando
country: United States
facility: Orlando Health Heart Institute
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky - Gill Heart and Vascular Institute
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute Cardiology
state: Montana
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Greenville
country: United States
facility: Heart Rhythm Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Toledo
country: United States
facility: ProMedica Northwest Ohio Cardiology Consultants
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Institute for Clinical Research
state: Tennessee
Study officials:
affiliation: University of Cincinnati Heart
name: Alexandru Costea, MD
role: STUDY_CHAIR
References: