Persistent Atrial FibrillationiTransmitNCT01912911
Evaluating the Efficacy and Feasibility of a Novel Wireless ECG Recording System in Monitoring Patients After Atrial Fibrillation Ablation Procedure
An observational study of Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators goal in this study is to examine the feasibility and efficacy of AliveCor iphone case monitoring device in monitoring patients after AF ablation by comparing transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor (TTM). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing A-fib ablations.
Who may be able to join
- Male or female between > 18 and < 75 years of age
- Paroxysmal or persistent atrial fibrillation
- Scheduled to undergo an AF ablation procedure
- Already has iPhone 4 or iPhone 4S with data plan
- Willing to use the iPhone Alive Cor case
- Written informed consent
Who cannot join
- Unable or unwilling to use the Alive Cor case for their iPhone or iPhone 4S
- Residing outside the United States
Trial locations and contacts
1 site in 1 country.
About this study
The investigators goal in this study is to examine the feasibility and efficacy of AliveCor iphone case monitoring device in monitoring patients after AF ablation by comparing transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor (TTM).
A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM system from the patient's perspective
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of AF/flutter events detected by the AliveCor device will be compared to events detected by the TTM for each episode.
Measured: 3 months
Secondary outcomes (1)
Amount of transmissions from smartphone in comparison with traditional TTM method
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaldoun Tarakji, The Cleveland Clinic
- Investigators
- Khaldoun Tarajki, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912911
- Sponsor's protocol ID
- 13-521
- Acronym
- iTransmit
- Status last verified
- Aug 2014
- First submitted
- 7 Jun 2013
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Feasibility of a Novel Wireless ECG Recording System in Monitoring Patients After Atrial Fibrillation Ablation Procedure
- ClinicalTrials.gov ID
- NCT01912911
- Acronym / sponsor ID
- iTransmit / 13-521
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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.
The investigators goal in this study is to examine the feasibility and efficacy of AliveCor iphone case monitoring device in monitoring patients after AF ablation by comparing transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor (TTM).
A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM system from the patient's perspective
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing A-fib ablations.
Key inclusion criteria (6 listed)
- Male or female between > 18 and < 75 years of age
- Paroxysmal or persistent atrial fibrillation
- Scheduled to undergo an AF ablation procedure
- Already has iPhone 4 or iPhone 4S with data plan
- Willing to use the iPhone Alive Cor case
Key exclusion criteria (2 listed)
- Unable or unwilling to use the Alive Cor case for their iPhone or iPhone 4S
- Residing outside the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of AF/flutter events detected by the AliveCor device will be compared to events detected by the TTM for each episode.
Time frame: 3 months
1 secondary outcome
Amount of transmissions from smartphone in comparison with traditional TTM method
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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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.
Khaldoun Tarajki, MD principal investigator
The Cleveland 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 Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, run by The Cleveland Clinic 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 7 Aug 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of AF/flutter events detected by the AliveCor device will be compared to events detected by the TTM for each episode. (time frame: 3 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 7 Aug 2014.