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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CRT-DX System
Device: CRT-DX
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Clinical Composite Score from baseline
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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