Data Collection Atrial Fibrillation Exploratory Study

Atrial Fibrillation Clinical Trial

— CAFE  

Official title:

Data Collection Atrial Fibrillation Exploratory Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03647085
• Other study ID #: C2106
• Status: Terminated
• Start date: August 29, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: May 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Device:
• Wearable cardiac monitor
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Locations

Country	Name	City	State
United States	Mayo Clinic Foundation	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiologic Signal Detection	Characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device.	12 months