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Data Collection Atrial Fibrillation Exploratory Study (CAFE Trial)
N/A
Waitlist Available
Led By Bruce Johnson, PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
To characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device. To evaluate the relationship of AFib/AFl symptom severity with various physiologic signals measured from the wearable cardiac monitor prototype device.
Eligible Conditions
- Atrial Flutter
- Atrial Fibrillation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physiologic Signal Detection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3 Wearable Cardiac MonitorExperimental Treatment1 Intervention
Patients diagnosed with, and currently in, atrial flutter at the time of enrollment and are scheduled for an ablation or cardioversion.
Group II: Group 2 Wearable Cardiac MonitorExperimental Treatment1 Intervention
Patients diagnosed with, and currently in, paroxysmal atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.
Group III: Group 1 Wearable Cardiac MonitorExperimental Treatment1 Intervention
Patients diagnosed with, and currently in, persistent atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Wearable cardiac monitor
2020
N/A
~100
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
745 Previous Clinical Trials
857,815 Total Patients Enrolled
10 Trials studying Atrial Flutter
1,419 Patients Enrolled for Atrial Flutter
Bruce Johnson, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
127 Total Patients Enrolled