Atrial FibrillationPhase 1/2NCT02914860
Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology
A Phase 1/2 study testing Cardiac CT, Ablation Procedure and D-SPECT in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiac CT, Ablation Procedure and D-SPECT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2016to Jun 2017
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients, age ≥ 18 and ≤ 80 years.
- Male or female, age ≥ 50 years in the healthy volunteers group
- No heart pathology (for volunteers)
- PAF, Pers AF and L-s Pers AF (ECG documented).
- LVEF ≥ 50%
- Able to provide written informed consent
- Able to comply with the requirements of the study
Who cannot join
- Previous AF ablation therapy
- Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
- Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
- Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
- Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures
Trial locations and contacts
1 site in 1 country.
Alexander Romanov contact
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, 630055
Evgeny Pokushalov, MD, PhD, +79139254858, E.Pokushalov@gmail.com
Evgeny Pokushalov, MD, PhD
About this study
The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.
- Conditions
- Atrial Fibrillation
- Being tested
- Cardiac CT, Ablation Procedure, D-SPECT
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTDevice
- Cardiac CT - contract enhanced cardiac CT according to standard protocol
- D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)
- Merge CT and D-SPECT image data to generate SUMO map.
Ablation ProcedureProcedure or surgery
- CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO.
- High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline).
- RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts)
- Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA
- Control HFS
- At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.
- Exit and entrance block confirmation
- Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.
D-SPECTDevice
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Experimental | Healthy volunteers Receives: Device: Cardiac CT; Device: D-SPECT |
| PAF | Active comparator | Patients with paroxysmal atrial fibrillation Receives: Device: Cardiac CT; Procedure: Ablation Procedure; Device: D-SPECT |
| Pers AF | Active comparator | Patients with persistent atrial fibrillation Receives: Device: Cardiac CT; Procedure: Ablation Procedure; Device: D-SPECT |
| L-s Pers AF | Active comparator | Patients with long-standing persistent atrial fibrillation Receives: Device: Cardiac CT; Procedure: Ablation Procedure; Device: D-SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
location of discrete uptake accumulations
Measured: 1 week
Secondary outcomes (1)
adverse events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Spectrum Dynamics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914860
- Sponsor's protocol ID
- Volunteers+AF patients
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology
- ClinicalTrials.gov ID
- NCT02914860
- Acronym / sponsor ID
- Volunteers+AF patients
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Spectrum Dynamics
- Study start
- Sep 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 26 Sep 2016 (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 purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Experimental | Device: Cardiac CT, Device: D-SPECTHealthy volunteers |
| PAF | Active comparator | Device: Cardiac CT, Procedure: Ablation Procedure, Device: D-SPECTPatients with paroxysmal atrial fibrillation |
| Pers AF | Active comparator | Device: Cardiac CT, Procedure: Ablation Procedure, Device: D-SPECTPatients with persistent atrial fibrillation |
| L-s Pers AF | Active comparator | Device: Cardiac CT, Procedure: Ablation Procedure, Device: D-SPECTPatients with long-standing persistent atrial fibrillation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients, age ≥ 18 and ≤ 80 years.
- Male or female, age ≥ 50 years in the healthy volunteers group
- No heart pathology (for volunteers)
- PAF, Pers AF and L-s Pers AF (ECG documented).
- LVEF ≥ 50%
Key exclusion criteria (5 listed)
- Previous AF ablation therapy
- Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
- Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
- Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
- Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures
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 |
|---|---|---|
| Cardiac CT* Cardiac CT - contract enhanced cardiac CT according to standard protocol * D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden) * Merge CT and D-SPECT image data to generate SUMO map. | Device | L-s Pers AF, PAF, Pers AF, Volunteers |
| Ablation Procedure1. CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. 2. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). 3. RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts) 4. Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA 5. Control HFS 6. At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures. 7. Exit and entrance block confirmation 8. Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia. | Procedure or surgery | L-s Pers AF, PAF, Pers AF |
| D-SPECT | Device | L-s Pers AF, PAF, Pers AF, Volunteers |
Primary outcome
location of discrete uptake accumulations
Time frame: 1 week
1 secondary outcome
adverse events
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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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.
Alexander Romanov contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cardiac CT, Ablation Procedure and D-SPECT in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 7 inclusion and 5 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 26 Sep 2016. 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 Russia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Alexander Romanov (abromanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
location of discrete uptake accumulations (time frame: 1 week). 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 26 Sep 2016.