Status:
TERMINATED
Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System
Lead Sponsor:
Biotronik, Inc.
Conditions:
Heart Failure
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 empha...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04870281
Start Date
May 28 2021
End Date
December 29 2021
Last Update
January 28 2022
Active Locations (23)
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1
University of California San Diego - La Jolla
La Jolla, California, United States, 92037
2
Cardiology Associates Medical Group
Ventura, California, United States, 93003
3
Orlando Health Heart Institute
Orlando, Florida, United States, 38806
4
AdventHealth Tampa
Tampa, Florida, United States, 33613