Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System
NCT ID: NCT04870281
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
13 participants
OBSERVATIONAL
2021-05-28
2021-12-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
NCT01774357
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
NCT06989580
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
NCT04869527
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
NCT00559988
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
NCT02323503
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CRT-DX System
CRT-DX
Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CRT-DX
Evaluation of overall health, including heart failure and atrial fibrillation improvement, changes in physical fitness, and general quality of life.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandru Costea, MD
Role: STUDY_CHAIR
University of Cincinnati Heart
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Diego - La Jolla
La Jolla, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Orlando Health Heart Institute
Orlando, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky - Gill Heart and Vascular Institute
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Glacier View Research Institute Cardiology
Kalispell, Montana, United States
Weill Cornell Medicine
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Heart Rhythm Associates
Greenville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
ProMedica Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Upstate Cardiology
Greenville, South Carolina, United States
Erlanger Institute for Clinical Research
Chattanooga, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIO-AffectDX
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.