Atrial FibrillationNCT00915720
Implanted Loop Recorder Post Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation, run by Thoracic & Cardiovascular Healthcare Foundation at 1 site in United States.
Trial summary
This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2012
- 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 undergoing surgical atrial fibrillation
Who may be able to join
- Patients undergoing surgical atrial fibrillation ablation
- Patients must be 18 years or older
Who cannot join
- Patients unwilling to comply with the follow up schedule
- Pregnant or breastfeeding patients
- Patients currently participating in another study
Trial locations and contacts
1 site in 1 country.
United States1 site
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
About this study
Official title: Implanted Loop Recorder Surveillance of Recurrent Atrial Fibrillation After Atrial Fibrillation Ablation
This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.
Read the detailed description
Atrial Fibrillation (AF)is the most common arrhythmia and causes significant morbidity and mortality. Treatment for AF consists of medical therapy and ablation therapy. Medical therapies can help approximately 50% of patients, the rest must resort to ablation procedures.
Ablation procedures aim to isolate the pulmonary vein from the atrial tissue electrically and can be performed either endocardially through catheters inserted through the femoral veins or epicardially through a minimal lateral thoracotomy. Both procedures are accepted as standard of care.
Recurrent AF after ablation therapy can be common and occurs in 50% of patients and could be in a form of short periods of AF or persistent AF with less or minimal symptoms. This is of significant clinical relevance as most of these AF episodes are not recognized and can lead to thromboembolic events such as stroke. However, techniques of surveillance of AF post ablation have been suboptimal. Physicians could use holter monitoring but this is limited to a short period of 24 - 48 hours. Event recorders which are external can be used but patients need to experience symptoms associated with the AF episodes in order to record the episodes.
Better AF monitoring techniques especially after AF ablation are necessary so that recognition of AF recurrence in these patient could be possible and timely anticoagulation therapy initiated may prevent strokes.
This pilot study involves implanting a loop recorder just under the skin to record cardiac rhythms 24 hours per day without any interaction by the patient. These devices are currently approved by the FDA for monitoring of syncope and will be implanted during the patients AF ablation surgery.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Surgical Ablation, Implanted loop recorder, Atrial Fibrillation Ablation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence/Duration of atrial and tachyarrhythmias post AF ablation
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
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.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thoracic & Cardiovascular Healthcare Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, AtriCure, Inc.
- Investigators
- John H Ip, MD, Principal investigator, Thoracic & Cardiovascular Healthcare Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915720
- Sponsor's protocol ID
- ILR 1208
- Status last verified
- Jul 2010
- First submitted
- 4 Jun 2009
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implanted Loop Recorder Surveillance of Recurrent Atrial Fibrillation After Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT00915720
- Acronym / sponsor ID
- ILR 1208
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Surgical Ablation, Implanted loop recorder, Atrial Fibrillation Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Thoracic & Cardiovascular Healthcare FoundationUniversity, hospital or other
- Collaborators
- Medtronic, AtriCure, Inc.
- Study start
- Aug 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Jun 2009 (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.
This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.
Detailed description
Atrial Fibrillation (AF)is the most common arrhythmia and causes significant morbidity and mortality. Treatment for AF consists of medical therapy and ablation therapy. Medical therapies can help approximately 50% of patients, the rest must resort to ablation procedures.
Ablation procedures aim to isolate the pulmonary vein from the atrial tissue electrically and can be performed either endocardially through catheters inserted through the femoral veins or epicardially through a minimal lateral thoracotomy. Both procedures are accepted as standard of care.
Recurrent AF after ablation therapy can be common and occurs in 50% of patients and could be in a form of short periods of AF or persistent AF with less or minimal symptoms. This is of significant clinical relevance as most of these AF episodes are not recognized and can lead to thromboembolic events such as stroke. However, techniques of surveillance of AF post ablation have been suboptimal. Physicians could use holter monitoring but this is limited to a short period of 24 - 48 hours. Event recorders which are external can be used but patients need to experience symptoms associated with the AF episodes in order to record the episodes.
Better AF monitoring techniques especially after AF ablation are necessary so that recognition of AF recurrence in these patient could be possible and timely anticoagulation therapy initiated may prevent strokes.
This pilot study involves implanting a loop recorder just under the skin to record cardiac rhythms 24 hours per day without any interaction by the patient. These devices are currently approved by the FDA for monitoring of syncope and will be implanted during the patients AF ablation surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical atrial fibrillation
Key inclusion criteria (2 listed)
- Patients undergoing surgical atrial fibrillation ablation
- Patients must be 18 years or older
Key exclusion criteria (3 listed)
- Patients unwilling to comply with the follow up schedule
- Pregnant or breastfeeding patients
- Patients currently participating in another study
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
Incidence/Duration of atrial and tachyarrhythmias post AF ablation
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
Related trials for Atrial Fibrillation
Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruiting
Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
Atrial Fibrillation (AF), Heart Failure
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.
John H Ip, MD principal investigator
Thoracic & Cardiovascular Healthcare Foundation
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, run by Thoracic & Cardiovascular Healthcare Foundation 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jul 2011. 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?
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?
Incidence/Duration of atrial and tachyarrhythmias post AF ablation (time frame: 14 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 20 Jul 2011.