Heart FailureBIO-AffectDXNCT04870281
Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System
An observational study of Heart Failure and Atrial Fibrillation, run by Biotronik, Inc. at 23 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation, Cardiac Resynchronization Therapy
- What is being tested?
- CRT-DX
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 23 sitesUnited States
- Study dates
- 28 May 2021to 29 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Erlanger Institute for Clinical Research
Chattanooga, Tennessee, 37403
University of Cincinnati
Cincinnati, Ohio, 45267
Heart Rhythm Associates
Greenville, North Carolina, 27834
Upstate Cardiology
Greenville, South Carolina, 29607
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Glacier View Research Institute Cardiology
Kalispell, Montana, 59901
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California San Diego - La Jolla
La Jolla, California, 92037
Baptist Health Lexington
Lexington, Kentucky, 40503
University of Kentucky - Gill Heart and Vascular Institute
Lexington, Kentucky, 40536
Weill Cornell Medicine
New York, New York, 10021
Lenox Hill Hospital
New York, New York, 10075
Orlando Health Heart Institute
Orlando, Florida, 38806
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Mercy Hospital Springfield
Springfield, Missouri, 65804
AdventHealth Tampa
Tampa, Florida, 33613
ProMedica Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43615
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
Cardiology Associates Medical Group
Ventura, California, 93003
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
Official title: 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.
Read the 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.
- Being tested
- CRT-DX
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-DXDevice
Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.
| Study group | Role | What they receive |
|---|---|---|
| CRT-DX System | Not described Receives: Device: CRT-DX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Composite Score from baseline
Measured: 12 months
Secondary outcomes (8)
Rate of composite all-cause death and heart failure
Measured: 12 months
Change in quality of life questionnaires from baseline for all patients and by atrial fibrillation sub-type
Measured: 6 and 12 months
Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type
Measured: 6 and 12 months
Change in six-minute walk distance from baseline for all patients and by atrial fibrillation sub-type
Measured: 6 and 12 months
Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type
Measured: 6 and 12 months
Change in Clinical Composite Score from baseline
Measured: 6 months
Rate of major complications
Measured: 12 months
Rate of conversion to sinus rhythm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start28 May 2021
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Why it stopped: The study terminated due to significant delays in site start-up activities and enrollment in the setting of the ongoing COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandru Costea, MD, Study chair, University of Cincinnati Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870281
- Sponsor's protocol ID
- BIO-AffectDX
- Acronym
- BIO-AffectDX
- Status last verified
- Jan 2022
- First submitted
- 26 Apr 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO-AffectDX Clinical Study
- ClinicalTrials.gov ID
- NCT04870281
- Acronym / sponsor ID
- BIO-AffectDX / BIO-AffectDX
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study terminated due to significant delays in site start-up activities and enrollment in the setting of the ongoing COVID-19 pandemic.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT-DX System | – | Device: CRT-DX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-DXEvaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life. | Device | CRT-DX System |
Primary outcome
Change in Clinical Composite Score from baseline
Time frame: 12 months
8 secondary outcomes
Rate of composite all-cause death and heart failure
Time frame: 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
Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type
Time frame: 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
Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type
Time frame: 6 and 12 months
Change in Clinical Composite Score from baseline
Time frame: 6 months
Rate of major complications
Time frame: 12 months
Rate of conversion to sinus rhythm
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The study terminated due to significant delays in site start-up activities and enrollment in the setting of the ongoing COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandru Costea, MD study chair
University of Cincinnati Heart
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Atrial Fibrillation, run by Biotronik, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study terminated due to significant delays in site start-up activities and enrollment in the setting of the ongoing COVID-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Composite Score from baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.