Atrial FibrillationNCT00871390
Organization of Excitation in People With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University of Michigan at 2 sites in United States.
Trial summary
Atrial fibrillation (AF) is a condition in which the upper chambers of the heart, the atria, undergo an irregular beating rhythm. Despite the fact that AF is the most common type of sustained cardiac rhythm disturbance the investigators still do not understand it entirely and its current therapies are only marginally… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Aug 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with paroxysmal and chronic atrial fibrilation (AF).
Who may be able to join
- Clinical indication for curative ablation of AF
- Patients will be enrolled as they are referred for the ablation therapy or post open heart surgery
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Complex Electrograms in Atrial Fibrillation: Spatiotemporal Organization and Mechanistic Insights and Organization in Acute Atrial Fibrillation Post Open Heart Surgery
Atrial fibrillation (AF) is a condition in which the upper chambers of the heart, the atria, undergo an irregular beating rhythm. Despite the fact that AF is the most common type of sustained cardiac rhythm disturbance the investigators still do not understand it entirely and its current therapies are only marginally effective. The overall goal of our project is to determine the organization and mechanisms of electrical activation patterns during AF in humans.
Read the detailed description
Experiments in animal hearts demonstrated that some cases of atrial fibrillation (AF) may be maintained by a small number of drivers in the form of self-sustained, reentrant, electrical impulses located in the posterior left atrium (LA) wall, near the pulmonary veins (PV/LA junction). In those experiments, the fastest rotors acted as the highest frequency drivers that maintained the overall activity. This resulted in a hierarchy of local excitation frequencies throughout both atria. More recently, clinical studies have confirmed the existence of a hierarchical organization in the rate of activation of different regions in the atria of patients with paroxysmal and chronic atrial fibrillation. However, the mechanisms underlying such a hierarchical distribution of frequencies in human AF has not been explored. Our project will try to demonstrate the general hypothesis that both local activation frequency and degree of regularity, while different in different parts of the atrium, are distributed non-randomly, with different patterns of distribution in paroxysmal versus chronic AF patients. We further surmise that such patterns are the result of interrupted propagation of impulses emanating from the drivers localized at the site of highest frequency and organization activity, with a gradual reduction of activation frequency as the distance from the driver increases. To test our hypotheses we will use a combination of clinical and numerical studies. For the clinical part we will gather patients data in a collaborative site at Rochester, NY. The data obtained in that site will be analyzed and interpreted at the Institute for Cardiovascular Research in SUNY Upstate Medical University. For the numerical part, simulations on computer models of AF will be performed solely in the Institute for Cardiovascular Research. Our Specific Aims are: 1. Characterize the frequency of activation during AF in patients after heart surgery and relate it to the presence of fibrosis. 2. In computer simulations, to study the mechanisms of initiation and maintenance of AF at the PV/LA junction using three different computer models with increasing anatomical complexity (the description of the computer simulations is available only in the grant application). Successful achievement of our specific aims should help us advance understanding of the mechanisms and manifestations of this complex arrhythmia and may help to directly improve the efficacy of pharmacological and ablative therapies of AF in patients.
- Conditions
- Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation, Permanent/Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startSep 2006
- Primary completionAug 2011
- Study completionAug 2011
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 University of MichiganThe 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Omer Berenfeld, University of Michigan
- Investigators
- Omer Berenfeld, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871390
- Sponsor's protocol ID
- 628
- Other IDs
- P01HL039707
- Status last verified
- Jul 2017
- First submitted
- 27 Mar 2009
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Electrograms in Atrial Fibrillation: Spatiotemporal Organization and Mechanistic Insights and Organization in Acute Atrial Fibrillation Post Open Heart Surgery
- ClinicalTrials.gov ID
- NCT00871390
- Acronym / sponsor ID
- 628
- Conditions
- Atrial Fibrillation
- Keywords
- Paroxysmal Atrial Fibrillation, Permanent/Persistent Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Mar 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.
Atrial fibrillation (AF) is a condition in which the upper chambers of the heart, the atria, undergo an irregular beating rhythm. Despite the fact that AF is the most common type of sustained cardiac rhythm disturbance the investigators still do not understand it entirely and its current therapies are only marginally effective. The overall goal of our project is to determine the organization and mechanisms of electrical activation patterns during AF in humans.
Detailed description
Experiments in animal hearts demonstrated that some cases of atrial fibrillation (AF) may be maintained by a small number of drivers in the form of self-sustained, reentrant, electrical impulses located in the posterior left atrium (LA) wall, near the pulmonary veins (PV/LA junction). In those experiments, the fastest rotors acted as the highest frequency drivers that maintained the overall activity. This resulted in a hierarchy of local excitation frequencies throughout both atria. More recently, clinical studies have confirmed the existence of a hierarchical organization in the rate of activation of different regions in the atria of patients with paroxysmal and chronic atrial fibrillation. However, the mechanisms underlying such a hierarchical distribution of frequencies in human AF has not been explored. Our project will try to demonstrate the general hypothesis that both local activation frequency and degree of regularity, while different in different parts of the atrium, are distributed non-randomly, with different patterns of distribution in paroxysmal versus chronic AF patients. We further surmise that such patterns are the result of interrupted propagation of impulses emanating from the drivers localized at the site of highest frequency and organization activity, with a gradual reduction of activation frequency as the distance from the driver increases. To test our hypotheses we will use a combination of clinical and numerical studies. For the clinical part we will gather patients data in a collaborative site at Rochester, NY. The data obtained in that site will be analyzed and interpreted at the Institute for Cardiovascular Research in SUNY Upstate Medical University. For the numerical part, simulations on computer models of AF will be performed solely in the Institute for Cardiovascular Research. Our Specific Aims are: 1. Characterize the frequency of activation during AF in patients after heart surgery and relate it to the presence of fibrosis. 2. In computer simulations, to study the mechanisms of initiation and maintenance of AF at the PV/LA junction using three different computer models with increasing anatomical complexity (the description of the computer simulations is available only in the grant application). Successful achievement of our specific aims should help us advance understanding of the mechanisms and manifestations of this complex arrhythmia and may help to directly improve the efficacy of pharmacological and ablative therapies of AF in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal and chronic atrial fibrilation (AF).
Key inclusion criteria (2 listed)
- Clinical indication for curative ablation of AF
- Patients will be enrolled as they are referred for the ablation therapy or post open heart surgery
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 19 Jul 2017.
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
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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.
Omer Berenfeld principal investigator
University of Michigan
2 sites 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 University of Michigan at 2 sites 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 0 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 19 Jul 2017.