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BIO-AffectDX: Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System

Sponsor
Biotronik, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04870281
Collaborator
(none)
13
Enrollment
23
Locations
7.1
Actual Duration (Months)
0.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CRT-DX

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

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
BIO-AffectDX Clinical Study
Actual Study Start Date :
May 28, 2021
Actual Primary Completion Date :
Dec 29, 2021
Actual Study Completion Date :
Dec 29, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Clinical Composite Score from baseline [12 months]

Secondary Outcome Measures

  1. Rate of composite all-cause death and heart failure [12 months]

  2. Change in quality of life questionnaires from baseline for all patients and by atrial fibrillation sub-type [6 and 12 months]

  3. Change in New York Heart Association class from baseline for all patients and by atrial fibrillation sub-type [6 and 12 months]

  4. Change in six-minute walk distance from baseline for all patients and by atrial fibrillation sub-type [6 and 12 months]

  5. Change in atrial fibrillation burden from baseline for all patients and by atrial fibrillation sub-type [6 and 12 months]

  6. Change in Clinical Composite Score from baseline [6 months]

  7. Rate of major complications [12 months]

  8. Rate of conversion to sinus rhythm [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
6 University of Kansas Medical Center Kansas City Kansas United States 66160
7 Kansas City Heart Rhythm Institute Overland Park Kansas United States 66211
8 Baptist Health Lexington Lexington Kentucky United States 40503
9 University of Kentucky - Gill Heart and Vascular Institute Lexington Kentucky United States 40536
10 Massachusetts General Hospital Boston Massachusetts United States 02114
11 University of Michigan Ann Arbor Michigan United States 48109
12 Michigan Heart Ypsilanti Michigan United States 48197
13 Cardiology Associates of North Mississippi Tupelo Mississippi United States 38801
14 Mercy Hospital Springfield Springfield Missouri United States 65804
15 Glacier View Research Institute Cardiology Kalispell Montana United States 59901
16 Weill Cornell Medicine New York New York United States 10021
17 Lenox Hill Hospital New York New York United States 10075
18 Heart Rhythm Associates Greenville North Carolina United States 27834
19 University of Cincinnati Cincinnati Ohio United States 45267
20 ProMedica Northwest Ohio Cardiology Consultants Toledo Ohio United States 43615
21 Medical University of South Carolina Charleston South Carolina United States 29425
22 Upstate Cardiology Greenville South Carolina United States 29607
23 Erlanger Institute for Clinical Research Chattanooga Tennessee United States 37403

Sponsors and Collaborators

  • Biotronik, Inc.

Investigators

  • Study Chair: Alexandru Costea, MD, University of Cincinnati Heart

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT04870281
Other Study ID Numbers:
  • BIO-AffectDX
First Posted:
May 3, 2021
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation

Study Results

No Results Posted as of Jan 28, 2022