Atrial FibrillationCAFENCT03647085
Data Collection Atrial Fibrillation Exploratory Study
An observational study of Atrial Fibrillation and Atrial Flutter, run by Boston Scientific Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Wearable cardiac monitor
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 10 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with paroxysmal AFib or persistent AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Wearable cardiac monitor
- Keywords
- atrial fibrillation, atrial flutter, arrhythmia
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable cardiac monitorDevice
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Wearable cardiac monitor | |
| 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. Receives: Device: Wearable cardiac monitor | |
| 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. Receives: Device: Wearable cardiac monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Signal Detection
Characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start29 Aug 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Why it stopped: Due to COVID-19 and resourcing challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Johnson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647085
- Sponsor's protocol ID
- C2106
- Acronym
- CAFE
- Status last verified
- May 2022
- First submitted
- 23 Aug 2018
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection Atrial Fibrillation Exploratory Study
- ClinicalTrials.gov ID
- NCT03647085
- Acronym / sponsor ID
- CAFE / C2106
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- atrial fibrillation, atrial flutter, arrhythmia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 and resourcing challenges
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Wearable Cardiac Monitor | – | Device: Wearable cardiac monitorPatients diagnosed with, and currently in, persistent atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion. |
| Group 2 Wearable Cardiac Monitor | – | Device: Wearable cardiac monitorPatients diagnosed with, and currently in, paroxysmal atrial fibrillation at the time of enrollment and are scheduled for an ablation or cardioversion. |
| Group 3 Wearable Cardiac Monitor | – | Device: Wearable cardiac monitorPatients diagnosed with, and currently in, atrial flutter at the time of enrollment and are scheduled for an ablation or cardioversion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with paroxysmal AFib or persistent AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable cardiac monitorParticipants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals. | Device | Group 1 Wearable Cardiac Monitor, Group 2 Wearable Cardiac Monitor, Group 3 Wearable Cardiac Monitor |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Due to COVID-19 and resourcing challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Johnson, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 and resourcing challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic Signal Detection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022; AzTrials last refreshed its copy on 28 Oct 2026.