- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870281
Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System (BIO-AffectDX)
January 13, 2022 updated by: Biotronik, Inc.
BIO-AffectDX Clinical Study
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.
Study Overview
Status
Terminated
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- University of California San Diego - La Jolla
-
Ventura, California, United States, 93003
- Cardiology Associates Medical Group
-
-
Florida
-
Orlando, Florida, United States, 38806
- Orlando Health Heart Institute
-
Tampa, Florida, United States, 33613
- AdventHealth Tampa
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
Overland Park, Kansas, United States, 66211
- Kansas City Heart Rhythm Institute
-
-
Kentucky
-
Lexington, Kentucky, United States, 40503
- Baptist Health Lexington
-
Lexington, Kentucky, United States, 40536
- University of Kentucky - Gill Heart and Vascular Institute
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
Ypsilanti, Michigan, United States, 48197
- Michigan Heart
-
-
Mississippi
-
Tupelo, Mississippi, United States, 38801
- Cardiology Associates of North Mississippi
-
-
Missouri
-
Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
-
-
Montana
-
Kalispell, Montana, United States, 59901
- Glacier View Research Institute Cardiology
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medicine
-
New York, New York, United States, 10075
- Lenox Hill Hospital
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- Heart Rhythm Associates
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati
-
Toledo, Ohio, United States, 43615
- ProMedica Northwest Ohio Cardiology Consultants
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
Greenville, South Carolina, United States, 29607
- Upstate Cardiology
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- Erlanger Institute for Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CRT-DX System
|
Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Clinical Composite Score from baseline
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of composite all-cause death and heart failure
Time Frame: 12 months
|
12 months
|
Change in quality of life questionnaires from baseline for all patients and by atrial fibrillation sub-type
Time Frame: 6 and 12 months
|
6 and 12 months
|
Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type
Time Frame: 6 and 12 months
|
6 and 12 months
|
Change in six-minute walk distance from baseline for all patients and by atrial fibrillation sub-type
Time Frame: 6 and 12 months
|
6 and 12 months
|
Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type
Time Frame: 6 and 12 months
|
6 and 12 months
|
Change in Clinical Composite Score from baseline
Time Frame: 6 months
|
6 months
|
Rate of major complications
Time Frame: 12 months
|
12 months
|
Rate of conversion to sinus rhythm
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Alexandru Costea, MD, University of Cincinnati Heart
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2021
Primary Completion (Actual)
December 29, 2021
Study Completion (Actual)
December 29, 2021
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
May 3, 2021
Study Record Updates
Last Update Posted (Actual)
January 28, 2022
Last Update Submitted That Met QC Criteria
January 13, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-AffectDX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Applicable de-identified individual participant data will be made available to achieve aims in approved proposals, including but not limited to sub-analysis or meta-analysis that are not specifically pre-planned within the protocol.
IPD Sharing Time Frame
Beginning no later than 12 months and ending no earlier than 3 years following study closure.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
US Department of Veterans AffairsCompleted
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Duke University; St. Paul's Hospital... and other collaboratorsActive, not recruitingHeart Diseases | Heart Failure | Transplant; Failure, Heart | Heart Transplant Failure and Rejection | Heart Failure,Congestive | Transplant FailureCanada, United States
Clinical Trials on CRT-DX
-
Biotronik SE & Co. KGCompletedHeart Failure | TachyarrhythmiaNetherlands, Switzerland, Latvia, Germany, Austria, Hungary, Slovakia
-
AudibleHealth AI, Inc.University of South Florida; Analytical Solutions Group, Inc.; R. P. Chiacchierini... and other collaboratorsCompleted
-
Children's Hospital of PhiladelphiaWithdrawnLaryngopharyngeal RefluxUnited States
-
Cognoa, Inc.University of Missouri-ColumbiaCompletedChildren18-72 Months With a Suspicion Autistic DisorderUnited States
-
Genomic Health®, Inc.Registrat-MapiCompletedBreast CancerFrance
-
Boston Children's HospitalRecruitingUniventricular HeartUnited States
-
Sunnybrook Health Sciences CentreGenomic Health®, Inc.CompletedHormone Receptor Positive Malignant Neoplasm of BreastCanada
-
CardioDynamicsUnknownHeart Failure, CongestiveUnited States
-
Peking University Third HospitalRecruitingColorectal AdenomaChina
-
PreDxion Bio, Inc.UnknownMultiple Organ Failure