Atrial FibrillationNCT04313296
Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients
A study testing Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA) in people with Atrial Fibrillation, run by Crystal Blake-Parlin at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most common heart rhythm disorder seen in clinical practice, with an estimated 2.7-6.1 million people in the U.S. affected by the disorder [1]. Previous studies have demonstrated that left atrial volume is a predictive measure of incident atrial fibrillation [2]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 6 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- • Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion.
- The patient would also need to have had an echocardiogram within six months pre-cardioversion (performed for any reason) with a well visualized atrial roof in order to perform the measurements accurately using the TOMTEC-ARENA software.
Who cannot join
- • Patients with a mitral regurgitation greater than moderate (effective regurgitant orifice >= .2 mm2)
- Patients with post-surgical valve repair or replacement, if the procedure was done with a thoracotomy
- Any patient how has had any cardiac surgery requiring a thoracotomy
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation (AF) is the most common heart rhythm disorder seen in clinical practice, with an estimated 2.7-6.1 million people in the U.S. affected by the disorder [1]. Previous studies have demonstrated that left atrial volume is a predictive measure of incident atrial fibrillation [2]. This study aims to add to the literature by investigating predictive measures of left atrial global longitudinal strain (LA GLS) that would be suggestive of maintenance of normal sinus rhythm post cardioversion. If the investigators could gain insight on the connection between LA GLS and cardioversion among patients with atrial fibrillation, the investigators could potentially help the clinical management of patients pre/post cardioversion, and potentially change poor outcomes.
Read the detailed description
Atrial fibrillation (AF) is a heart rhythm disorder in which the normal beating in the upper chambers of the heart is irregular, leading to poor blood flow to the lower chambers. Risk factors include older age, high blood pressure, obesity, European ancestry, diabetes, heart failure, ischemic heart disease, hyperthyroidism, chronic kidney disease, heavy alcohol use, and enlarged heart chambers on the left side [3]. AF increases a person's risk for stroke and contributes to an estimated 130,000 deaths each year [1]. Treatment generally includes medication, surgery, and/or healthy lifestyle changes [1]. Electrical cardioversion, in which the patient must undergo sedation or general anesthesia, is also used to convert patients with persistent AF to normal sinus rhythm. Electrical cardioversion has been associated with a high initial success rate of 68-98% [4], but long-term maintenance of sinus rhythm has proved challenging [5]. Due to the potential risks incurred to the patient, it is important to understand which patients are good candidates for cardioversion therapy. A review article describes that duration of AF, sex, age, weight smoking status, number of shocks at cardioversion, post-ablation procedure, medications, hypertension, diabetes, Chronic Obstructive Pulmonary Disease (COPD), obstructive sleep apnea, renal impairment, hyperthyroidism, coronary artery disease, congestive heart failure, left systolic dysfunction, left diastolic dysfunction, left ventricular hypertrophy, valvular heart disease, and left atrial size have each been found to be associated with maintenance of sinus rhythm [6].
Echocardiography has been increasing used in understanding the cardiac structure and risk of stroke among patients with AF, with left atrial size, left ventricular wall thickness, and left ventricular dysfunction recognized as independent predictors of AF [7]. Increasing evidence supports that the left atrial strain measurements can be a predictor of outcomes among AF patients, including stroke and AF recurrence after catheter ablation [8], [9]. The investigators aim to further explore left atrial strain measurements, including left atrial global longitudinal strain (LA GLS), as predictors of maintenance of normal sinus rhythm post- cardioversion. It is anticipated that a lower LA GLS will predict AF recurrence. To do this, the investigators will study patients with AF at Pen Bay Medical Center who have undergone cardioversion, measuring their LA GLS pre-cardioversion, and assess maintenance of sinus rhythm 6 months post-cardioversion. It is anticipated that this study will confirm LA GLS as a marker for maintenance of sinus rhythm post-cardioversion.
- Conditions
- Atrial Fibrillation
- Being tested
- Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA)Device
The historic echocardiograms from patients who meet the study inclusion criteria will be uploaded into this software, which was newly acquired by the PBMC Cardiology Department. MaineHealth Information Services are currently working with study staff to assure appropriate security compliance within the network. LA GLS has not been routinely collected previously from echocardiograms performed at PBMC because of a lack of such technology.
| Study group | Role | What they receive |
|---|---|---|
| Patients identified at PBMC with a documented diagnosis of AF | Experimental | Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion. Receives: Device: Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After Cardioversion
Left atrial global longitudinal strain as measured utilizing the TOMTECH - ARENA software program compared to duration of the maintenance of sinus rhythm following elective cardioversion.
Time, in months, sinus rhythm was maintained.
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 posted18 Mar 2020
- Study start1 May 2020
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Why it stopped: Staff shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a retrospective and prospective cohort study of patients with atrial fibrillation (AF) identified at Pen Bay Medical Center (PBMC). Patients will be identified for inclusion in the study based on a previous documented diagnosis of AF, have a documented echocardiogram, and have undergone electrical cardioversion, with a study enrollment goal of 150 patients.
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crystal Blake-Parlin
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth
- Responsible party
- Sponsor-investigator, Crystal Blake-Parlin, MaineHealth
- Investigators
- Crystal Blake-Parlin, Principal investigator, Pen Bay Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313296
- Sponsor's protocol ID
- Blake-ParlinTOMTEC
- Status last verified
- Jul 2023
- First submitted
- 29 Jan 2019
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT04313296
- Acronym / sponsor ID
- Blake-ParlinTOMTEC
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staff shortage
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Crystal Blake-ParlinUniversity, hospital or other
- Collaborators
- MaineHealth
- Study start
- 1 May 2020 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is the most common heart rhythm disorder seen in clinical practice, with an estimated 2.7-6.1 million people in the U.S. affected by the disorder [1]. Previous studies have demonstrated that left atrial volume is a predictive measure of incident atrial fibrillation [2]. This study aims to add to the literature by investigating predictive measures of left atrial global longitudinal strain (LA GLS) that would be suggestive of maintenance of normal sinus rhythm post cardioversion. If the investigators could gain insight on the connection between LA GLS and cardioversion among patients with atrial fibrillation, the investigators could potentially help the clinical management of patients pre/post cardioversion, and potentially change poor outcomes.
Detailed description
Atrial fibrillation (AF) is a heart rhythm disorder in which the normal beating in the upper chambers of the heart is irregular, leading to poor blood flow to the lower chambers. Risk factors include older age, high blood pressure, obesity, European ancestry, diabetes, heart failure, ischemic heart disease, hyperthyroidism, chronic kidney disease, heavy alcohol use, and enlarged heart chambers on the left side [3]. AF increases a person's risk for stroke and contributes to an estimated 130,000 deaths each year [1]. Treatment generally includes medication, surgery, and/or healthy lifestyle changes [1]. Electrical cardioversion, in which the patient must undergo sedation or general anesthesia, is also used to convert patients with persistent AF to normal sinus rhythm. Electrical cardioversion has been associated with a high initial success rate of 68-98% [4], but long-term maintenance of sinus rhythm has proved challenging [5]. Due to the potential risks incurred to the patient, it is important to understand which patients are good candidates for cardioversion therapy. A review article describes that duration of AF, sex, age, weight smoking status, number of shocks at cardioversion, post-ablation procedure, medications, hypertension, diabetes, Chronic Obstructive Pulmonary Disease (COPD), obstructive sleep apnea, renal impairment, hyperthyroidism, coronary artery disease, congestive heart failure, left systolic dysfunction, left diastolic dysfunction, left ventricular hypertrophy, valvular heart disease, and left atrial size have each been found to be associated with maintenance of sinus rhythm [6].
Echocardiography has been increasing used in understanding the cardiac structure and risk of stroke among patients with AF, with left atrial size, left ventricular wall thickness, and left ventricular dysfunction recognized as independent predictors of AF [7]. Increasing evidence supports that the left atrial strain measurements can be a predictor of outcomes among AF patients, including stroke and AF recurrence after catheter ablation [8], [9]. The investigators aim to further explore left atrial strain measurements, including left atrial global longitudinal strain (LA GLS), as predictors of maintenance of normal sinus rhythm post- cardioversion. It is anticipated that a lower LA GLS will predict AF recurrence. To do this, the investigators will study patients with AF at Pen Bay Medical Center who have undergone cardioversion, measuring their LA GLS pre-cardioversion, and assess maintenance of sinus rhythm 6 months post-cardioversion. It is anticipated that this study will confirm LA GLS as a marker for maintenance of sinus rhythm post-cardioversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a retrospective and prospective cohort study of patients with atrial fibrillation (AF) identified at Pen Bay Medical Center (PBMC). Patients will be identified for inclusion in the study based on a previous documented diagnosis of AF, have a documented echocardiogram, and have undergone electrical cardioversion, with a study enrollment goal of 150 patients.
| Arm | Type | Receives |
|---|---|---|
| Patients identified at PBMC with a documented diagnosis of AF | Experimental | Device: Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA)Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients identified at PBMC with a documented diagnosis of AF (at any point in time) and who have undergone any cardioversion.
Key exclusion criteria (3 listed)
- • Patients with a mitral regurgitation greater than moderate (effective regurgitant orifice >= .2 mm2)
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 |
|---|---|---|
| Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA)The historic echocardiograms from patients who meet the study inclusion criteria will be uploaded into this software, which was newly acquired by the PBMC Cardiology Department. MaineHealth Information Services are currently working with study staff to assure appropriate security compliance within the network. LA GLS has not been routinely collected previously from echocardiograms performed at PBMC because of a lack of such technology. | Device | Patients identified at PBMC with a documented diagnosis of AF |
Primary outcome
Number of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After Cardioversion
Time frame: 12 months
Left atrial global longitudinal strain as measured utilizing the TOMTECH - ARENA software program compared to duration of the maintenance of sinus rhythm following elective cardioversion. Time, in months, sinus rhythm was maintained.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Crystal Blake-Parlin principal investigator
Pen Bay Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA) in people with Atrial Fibrillation, run by Crystal Blake-Parlin 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: stopped early, as of the sponsor's last update on 14 Aug 2023. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With a Relationship Between Left Atrial Global Longitudinal Strain and the Maintenance of Sinus Rhythm After Cardioversion (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 14 Aug 2023.