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Data Collection Atrial Fibrillation Exploratory Study (CAFE)

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ClinicalTrials.gov Identifier: NCT03647085
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief 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.


Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Flutter Device: Wearable cardiac monitor

Detailed Description:

The is a non-randomized feasibility study that will enroll up to 50 participants with an ongoing episode of AFib/AFl and are referred for a cardiac ablation or electrical cardioversion procedure. A maximum of 20 persistent AFib, 20 paroxysmal AFib, and 20 AFl participants will be enrolled, not to exceed 50 total. There will be up to three data collection visits.

Visit 1 will occur on the same day as enrollment and prior to the cardiac ablation or electrical cardioversion procedure. This allows collection of physiologic signals while the patient is in AFib or AFI.

Visit 2 will occur after the cardiac ablation or electrical cardioversion procedure; no earlier than the day after the cardiac ablation or electrical cardioversion procedure and no more than 4 months after the day of the procedure.

Visit 3 is optional, and may be scheduled upon sponsor's request, which will take place at least 5 months after the previous (second) data collection visit.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Collection Atrial Fibrillation Exploratory Study
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 Wearable Cardiac Monitor
Patients diagnosed with, and currently in, persistent atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.
Device: Wearable cardiac monitor
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Group 2 Wearable Cardiac Monitor
Patients diagnosed with, and currently in, paroxysmal atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion.
Device: Wearable cardiac monitor
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Group 3 Wearable Cardiac Monitor
Patients diagnosed with, and currently in, atrial flutter at the time of enrollment and are scheduled for an ablation or cardioversion.
Device: Wearable cardiac monitor
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.




Primary Outcome Measures :
  1. Physiologic Signal Detection [ Time Frame: 12 months ]
    Characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with paroxysmal AFib or persistent AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure.
Criteria

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
  • Diagnosed with paroxysmal AFib or persistent AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure
  • Confirmed AFib/AFl 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647085


Contacts
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Contact: Ashley Jensen, MS 651.582.4908 ashley.jensen@bsci.com
Contact: Stephen Ruble, PhD 651.582.4397 stephen.ruble@bsci.com

Locations
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United States, Minnesota
Mayo Clinic Foundation Recruiting
Rochester, Minnesota, United States, 55905
Contact: Bruce Johnson, PhD    507-284-2511    johnson.bruce@mayo.edu   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Bruce Johnson, PhD Mayo Clinic

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03647085     History of Changes
Other Study ID Numbers: C2106
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Scientific Corporation:
atrial fibrillation
atrial flutter
arrhythmia

Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes