Data Collection - Atrial Fibrillation Exploratory Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-001186
Sponsor Protocol Number: 92224609
About this study
The purpose of this study is to characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable Insertable Cardiac Monitor (ICM) prototype device.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Able to understand and willing to provide written informed consent to participate in the trial.
- Age 18 years old or greater.
- Willing and able to participate in study visits and the required testing.
- Primary diagnosis of AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure.
- Confirmed not in a normal heart rhythm at the time of enrollment.
Exclusion Criteria:
- Currently enrolled in another clinical trial that may interfere with the placement of study system or include the usage of unapproved drugs.
- Participant is pregnant or planning to become pregnant during the study.
- Diagnosed with permanent AFib.
- Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
- Known allergy to materials used in the study (adhesive tape, ECG electrodes).
- Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available