Atrial FibrillationPhase 2NCT02492256
Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF
A Phase 2 study testing Pulmonary vein isolation, GP ablation guided by SUMO technology and ILR implantation in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation, GP ablation guided by SUMO technology and ILR implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2015to Aug 2016
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, age ≥ 18 and ≤ 80 years.
- Persistent AF (ECG documentation).
- Indication for AF ablation.
- LVEF ≥ 50%
- Able to provide written informed consent
- Able to comply with the requirements of the study
Who cannot join
- Reversible cause of atrial fibrillation
- 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
- Inability to undergo D-SPECT and CT imaging
Trial locations and contacts
1 site in 1 country.
Alexander Romanov, MD, PhD contact
Marina Nikitenko 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
Official title: Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Persistent Atrial Fibrillation Patients: Prospective Randomized Study
Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical outcome in patients with persistent AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation, GP ablation guided by SUMO technology, ILR implantation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationDevice
CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. Conventional PVI by circumferential antral ablation according to standard procedures. Exit and Entrance block conformation. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.
GP ablation guided by SUMO technologyDevice
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 of SUMO hotspots (in sinus rhythm if AF converts)
- Target a region of 1.0-1.5 cm diameter around the SUMO 'hotspot'. Control HFS. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.
ILR implantationDevice
Implantation the ECG loop recorder according to standard procedure
| Study group | Role | What they receive |
|---|---|---|
| PVI group | Active comparator | Conventional PVI by circumferential antral ablation according to standard procedures. Receives: Device: Pulmonary vein isolation; Device: ILR implantation |
| PVI+GP guided by SUMO technology group | Experimental | Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology. Receives: Device: GP ablation guided by SUMO technology; Device: ILR implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without AF/AFl/AT
Measured: 12 months
Secondary outcomes (2)
Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%).
Measured: 12 month
Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492256
- Sponsor's protocol ID
- SPT15429
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Persistent Atrial Fibrillation Patients: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02492256
- Acronym / sponsor ID
- SPT15429
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jun 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 8 Jul 2015 (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.
Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical outcome in patients with persistent AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI group | Active comparator | Device: Pulmonary vein isolation, Device: ILR implantationConventional PVI by circumferential antral ablation according to standard procedures. |
| PVI+GP guided by SUMO technology group | Experimental | Device: GP ablation guided by SUMO technology, Device: ILR implantationConventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients, age ≥ 18 and ≤ 80 years.
- Persistent AF (ECG documentation).
- Indication for AF ablation.
- LVEF ≥ 50%
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Reversible cause of atrial fibrillation
- 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
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 |
|---|---|---|
| Pulmonary vein isolationCARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. Conventional PVI by circumferential antral ablation according to standard procedures. Exit and Entrance block conformation. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia. | Device | PVI group |
| GP ablation guided by SUMO technologyCARTO- 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 of SUMO hotspots (in sinus rhythm if AF converts) • Target a region of 1.0-1.5 cm diameter around the SUMO 'hotspot'. Control HFS. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia. | Device | PVI+GP guided by SUMO technology group |
| ILR implantationImplantation the ECG loop recorder according to standard procedure | Device | PVI group, PVI+GP guided by SUMO technology group |
Primary outcome
Number of patients without AF/AFl/AT
Time frame: 12 months
2 secondary outcomes
Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%).
Time frame: 12 month
Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT.
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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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.
Alexander Romanov, MD, PhD contact
Marina Nikitenko contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulmonary vein isolation, GP ablation guided by SUMO technology and ILR implantation 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 6 inclusion and 7 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 8 Jul 2015. 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 phase mean?
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, MD, PhD (abromanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients without AF/AFl/AT (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 8 Jul 2015.