Supra-ventricular TachyarrhythmiasPhase 2NCT02008461
Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias
A Phase 2 study testing radiofrequency ablation and botulinum toxin injection in people with Supra-ventricular Tachyarrhythmias, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in 2 countries.
Trial summary
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Supra-ventricular Tachyarrhythmias
- What is being tested?
- radiofrequency ablation and botulinum toxin injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2013to Feb 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome
- secondary atrial fibrillation
Who cannot join
- congestive heart failure
- LV ejection fraction < 35%
- left atrial diameter > 60 mm
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
- Active, not recruiting
University of Rochester
Rochester, New York, 11528
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of Circulation Pathology
Novosibirsk, 630055
Evgeny Pokushalov, MD, PhD, +79139254858, E.Pokushalov@gmail.com
Evgeny Pokushalov, MD, PhD
About this study
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).
- Conditions
- Supra-ventricular Tachyarrhythmias
- Being tested
- radiofrequency ablation, botulinum toxin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
botulinum toxin injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| RFA | Active comparator | Mapping and radiofrequency ablation are performed by using standard methods. Receives: Procedure: radiofrequency ablation |
| RFA+BT injection | Active comparator | Mapping and radiofrequency ablation are performed by using standard methods.
Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster). Receives: Procedure: radiofrequency ablation; Drug: botulinum toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of episodes of atrial fibrillation
Measured: 1 year
Secondary outcomes (1)
serious adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supra-ventricular TachyarrhythmiasStudies 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
- NCT02008461
- Sponsor's protocol ID
- BT_SVT
- Status last verified
- Sep 2015
- First submitted
- 6 Dec 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias
- ClinicalTrials.gov ID
- NCT02008461
- Acronym / sponsor ID
- BT_SVT
- Conditions
- Supra-ventricular Tachyarrhythmias
- 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 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 11 Dec 2013 (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 investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA | Active comparator | Procedure: radiofrequency ablationMapping and radiofrequency ablation are performed by using standard methods. |
| RFA+BT injection | Active comparator | Procedure: radiofrequency ablation, Drug: botulinum toxin injectionMapping and radiofrequency ablation are performed by using standard methods. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome
- secondary atrial fibrillation
Key exclusion criteria (3 listed)
- congestive heart failure
- LV ejection fraction < 35%
- left atrial diameter > 60 mm
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 |
|---|---|---|
| radiofrequency ablation | Procedure or surgery | RFA, RFA+BT injection |
| botulinum toxin injection | Drug | RFA+BT injection |
Primary outcome
number of episodes of atrial fibrillation
Time frame: 1 year
1 secondary outcome
serious adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- State Research Institute of Circulation Pathology Official SiteLink provided by the sponsor.
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiofrequency ablation and botulinum toxin injection in people with Supra-ventricular Tachyarrhythmias, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. 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, 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 Evgeny Pokushalov, MD, PhD (+79139254858, e.pokushalov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of episodes of atrial fibrillation (time frame: 1 year). 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 23 Sep 2015.