Arrhythmias, CardiacAF-ActivateNCT02063191
Activation Timing and Atrial Fibrillation
An observational study of Arrhythmias, Cardiac and Atrial Fibrillation, run by Essentia Health at 1 site in United States.
Trial summary
This is a single center, non-randomized, unblinded study of patients who are followed at Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated diagnostic electrophysiology (EP) study with or without ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Atrial Fibrillation, Bundle Branch Block
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single center study of patients who are followed at Essentia Health - St. Mary's Medical Center who are referred for a clinically indicated diagnostic EP study with or without ablation.
Who may be able to join
- any patient followed at Essentia Health - St. Mary's Medical Center, Duluth, MN and who is referred for a diagnostic EP study with or without ablation.
Who cannot join
- any patient who will undergo an EP study without usual placement of a coronary sinus catheter;
- any patient with permanent (chronic) atrial fibrillation or tachycardia who will not undergo restoration of sinus rhythm during the course of the procedure as a usual part of the procedure;
- any patient who is not willing or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof-of-concept Study to Assess Ventricular Activation Timing During Atrial Fibrillation, or Bundle Branch Block and Sinus Rhythm
This is a single center, non-randomized, unblinded study of patients who are followed at Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated diagnostic electrophysiology (EP) study with or without ablation. During the procedure, events of atrial fibrillation, sinus rhythm and bundle branch block that may occur during the course of the case will be saved electronically and analyzed offline. The stored data will be evaluated off-line for changes in activation timing of the near and far field ventricular signals of the stored events.
This proof-of-concept study will attempt to assess whether atrial fibrillation, or bundle branch block can change activation timing compared to baseline sinus rhythm. If no significant activation change is seen, then this finding can be used as a basis to distinguish ventricular tachycardia from atrial fibrillation in future rhythm discrimination methods.
Read the detailed description
General Approach: Single center, non-randomized, unblinded study of patients who are followed at Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated diagnostic EP study with or without ablation. During the procedure, events of atrial fibrillation, sinus rhythm or bundle branch block that may occur during the course of the case will be saved electronically and analyzed offline. These events may occur during the routine, clinically indicated portion of the procedure and will be saved should they occur. The stored data will be evaluated for changes in activation timing of the near- and far field ventricular signals of the stored events.
Methods and Materials: Up to 50 patients will be enrolled by the primary investigator and/or associate investigators. As part of a usual EP study, catheters are placed in the coronary sinus and right ventricle. For studies involving catheter ablation of atrial fibrillation or other complex arrhythmias, a 3-dimensional mapping system is frequently used for catheter location in 3-dimensional space and is left to the clinical discretion of the operator at the time of the procedure. An EP-Med WorkMate workstation will be used to record and measure events as part of the usual clinical procedure.
- Data Acquisition: During the course of the case, a catheters placed in the right ventricular apex and coronary sinus will be used to record both near- and far-field signal during episodes of atrial fibrillation, sinus rhythm and bundle branch conduction disturbances should they occur. Near field-signal will be recorded between the distal and proximal pair of the catheter located in the right ventricular apex. Far-field signal will be measured between the distal electrode of the catheter in the right ventricular apex and distal electrode of the coronary sinus catheter. If 3-dimensional mapping is available, the spatial location of the right ventricular and coronary sinus catheters will be recorded. If 3-dimensional mapping is not available, fluoroscopic maps of catheter positions will be obtained. Recorded signal will be saved on the EP-Med WorkMate workstation at a sampling rate of 2000 Hz and amplitude of 78 nV per unit.
- Analysis: Patient identifiers will be purged from the saved events and printouts, and a study identification number will be assigned. Those saved events will be extracted for input into Matlab or Octave for analysis. Custom algorithms written by the primary investigator will be used. Both the ventricular far-field and ventricular nearfield electrograms will be analyzed. Initially, 3 consecutive ventricular signals during sinus rhythm will be evaluated for each patient and averaged to estimate the activation timing changes. A baseline template or reference activation sequence will be created for each patient and will be used as the reference for all further events from that patient. The signal will be rectified but no additional filtering will be applied. Using the peak farfield signal as time 0, the difference between near- and far-field peak signals will be measured and averaged for the three ventricular events. In turn any available atrial fibrillation or bundle branch block conduction disturbance evens will be analyzed using the same techniques. Differences between the reference activation sequence and other events will be measured and compared. In Figure 1, the upper pane shows an episode of baseline rhythm (sinus rhythm). During baseline rhythm for this event, the near-field peak signal consistently comes after the far-field peak signal. During ventricular tachycardia, the two peaks are nearly simultaneous, representing a change in activation timing because of a change in the activation circuit in the ventricles.
- Keywords
- Atrial Fibrillation, Bundle Branch Block
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Patients with atrial fibrillation during the EP study | |
| Bundle Branch Block | Patient with bundle branch block during the course of the EP study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation Timing Shift
Measurement of activation change in near- and far-field ventricular signal between sinus rhythm and atrial fibrillation and/or bundle branch block.
Measured: During the course of the EP study with all measurements being obtained within 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Methods of activation timing measurements too imprecise
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mollerus, Essentia Health
- Investigators
- Michael E Mollerus, MD, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063191
- Sponsor's protocol ID
- EH13342
- Acronym
- AF-Activate
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study to Assess Ventricular Activation Timing During Atrial Fibrillation, or Bundle Branch Block and Sinus Rhythm
- ClinicalTrials.gov ID
- NCT02063191
- Acronym / sponsor ID
- AF-Activate / EH13342
- Keywords
- Atrial Fibrillation, Bundle Branch Block
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Methods of activation timing measurements too imprecise
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Feb 2014 (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 single center, non-randomized, unblinded study of patients who are followed at Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated diagnostic electrophysiology (EP) study with or without ablation. During the procedure, events of atrial fibrillation, sinus rhythm and bundle branch block that may occur during the course of the case will be saved electronically and analyzed offline. The stored data will be evaluated off-line for changes in activation timing of the near and far field ventricular signals of the stored events.
This proof-of-concept study will attempt to assess whether atrial fibrillation, or bundle branch block can change activation timing compared to baseline sinus rhythm. If no significant activation change is seen, then this finding can be used as a basis to distinguish ventricular tachycardia from atrial fibrillation in future rhythm discrimination methods.
Detailed description
General Approach: Single center, non-randomized, unblinded study of patients who are followed at Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated diagnostic EP study with or without ablation. During the procedure, events of atrial fibrillation, sinus rhythm or bundle branch block that may occur during the course of the case will be saved electronically and analyzed offline. These events may occur during the routine, clinically indicated portion of the procedure and will be saved should they occur. The stored data will be evaluated for changes in activation timing of the near- and far field ventricular signals of the stored events.
Methods and Materials: Up to 50 patients will be enrolled by the primary investigator and/or associate investigators. As part of a usual EP study, catheters are placed in the coronary sinus and right ventricle. For studies involving catheter ablation of atrial fibrillation or other complex arrhythmias, a 3-dimensional mapping system is frequently used for catheter location in 3-dimensional space and is left to the clinical discretion of the operator at the time of the procedure. An EP-Med WorkMate workstation will be used to record and measure events as part of the usual clinical procedure.
- Data Acquisition: During the course of the case, a catheters placed in the right ventricular apex and coronary sinus will be used to record both near- and far-field signal during episodes of atrial fibrillation, sinus rhythm and bundle branch conduction disturbances should they occur. Near field-signal will be recorded between the distal and proximal pair of the catheter located in the right ventricular apex. Far-field signal will be measured between the distal electrode of the catheter in the right ventricular apex and distal electrode of the coronary sinus catheter. If 3-dimensional mapping is available, the spatial location of the right ventricular and coronary sinus catheters will be recorded. If 3-dimensional mapping is not available, fluoroscopic maps of catheter positions will be obtained. Recorded signal will be saved on the EP-Med WorkMate workstation at a sampling rate of 2000 Hz and amplitude of 78 nV per unit.
- Analysis: Patient identifiers will be purged from the saved events and printouts, and a study identification number will be assigned. Those saved events will be extracted for input into Matlab or Octave for analysis. Custom algorithms written by the primary investigator will be used. Both the ventricular far-field and ventricular nearfield electrograms will be analyzed. Initially, 3 consecutive ventricular signals during sinus rhythm will be evaluated for each patient and averaged to estimate the activation timing changes. A baseline template or reference activation sequence will be created for each patient and will be used as the reference for all further events from that patient. The signal will be rectified but no additional filtering will be applied. Using the peak farfield signal as time 0, the difference between near- and far-field peak signals will be measured and averaged for the three ventricular events. In turn any available atrial fibrillation or bundle branch block conduction disturbance evens will be analyzed using the same techniques. Differences between the reference activation sequence and other events will be measured and compared. In Figure 1, the upper pane shows an episode of baseline rhythm (sinus rhythm). During baseline rhythm for this event, the near-field peak signal consistently comes after the far-field peak signal. During ventricular tachycardia, the two peaks are nearly simultaneous, representing a change in activation timing because of a change in the activation circuit in the ventricles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | –Patients with atrial fibrillation during the EP study |
| Bundle Branch Block | – | –Patient with bundle branch block during the course of the EP study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single center study of patients who are followed at Essentia Health - St. Mary's Medical Center who are referred for a clinically indicated diagnostic EP study with or without ablation.
Key inclusion criteria (1 listed)
- any patient followed at Essentia Health - St. Mary's Medical Center, Duluth, MN and who is referred for a diagnostic EP study with or without ablation.
Key exclusion criteria (3 listed)
- any patient who will undergo an EP study without usual placement of a coronary sinus catheter;
- any patient with permanent (chronic) atrial fibrillation or tachycardia who will not undergo restoration of sinus rhythm during the course of the procedure as a usual part of the procedure;
- any patient who is not willing or unable to provide informed consent.
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
Activation Timing Shift
Time frame: During the course of the EP study with all measurements being obtained within 12 hours
Measurement of activation change in near- and far-field ventricular signal between sinus rhythm and atrial fibrillation and/or bundle branch block.
Results and safety
The study was stopped early (reason given: Methods of activation timing measurements too imprecise). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
Michael E Mollerus, MD principal investigator
Essentia Health
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 Arrhythmias, Cardiac and Atrial Fibrillation, run by Essentia Health 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 1 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 4 Nov 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 was stopped early (reason given: Methods of activation timing measurements too imprecise). 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?
Activation Timing Shift (time frame: During the course of the EP study with all measurements being obtained within 12 hours). 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 4 Nov 2014.