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Paroxysmal Atrial FibrillationPhase 2NCT01842529

Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery

A Phase 2 study testing botulinum toxin injection, 0.9% normal saline injection and Implantable loop recorder in people with Paroxysmal Atrial Fibrillation and Indications for CABG, run by Meshalkin Research Institute of Pathology of Circulation at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this prospective randomized double-blind study was to compare the efficacy and safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
botulinum toxin injection, 0.9% normal saline injection and Implantable loop recorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesin 2 countries
Study dates
Sep 2012to Dec 2013
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PAF
  • Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery

Who cannot join

  • Previous heart surgery and AF ablation procedure
  • Emergency CABG
  • Unstable angina or heart failure
  • Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation)
  • Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
  • Requiring concomitant valve surgery
Show all 9Show fewer
  • Left ventricle ejection fraction <35%
  • Left atrial diameter >55 mm
  • Unwillingness to participate

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Russia2 sites

  • State Research Institute of Circulation Pathology

    Novosibirsk, 630055

  • Institute of Cardiology, Siberian Division of Russian Academy of Medical Sciences

    Tomsk

Other trials in Russia

United States1 site

  • The Valley Health System and Columbia University College of Physicians & Surgeons

    New York, New York

Other trials in United States

About this study

Official title: Botulinum Toxin Injection in Epicardial Fat Pads Can Prevent Recurrences of Atrial Fibrillation After Cardiac Surgery: Randomized Pilot Study

The aim of this prospective randomized double-blind study was to compare the efficacy and safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass graft (CABG) surgery.

Being tested
botulinum toxin injection, 0.9% normal saline injection, Implantable loop recorder
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • botulinum toxin injectionBiological

  • 0.9% normal saline injectionBiological

  • Implantable loop recorderDevice

Study groups in NCT01842529
Study groupRoleWhat they receive
CABG+ Botulinum toxinActive comparatorAll patients underwent conventional CABG. After the main stage of the surgery botulinum toxin (Xeomin, incobotulinumtoxin A, Merz Pharma GmbH \& Co KGaA, Germany; 50 U/1 mL at each fat pad; botulinum toxin group) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP.
Receives: Biological: botulinum toxin injection; Device: Implantable loop recorder
ControlActive comparatorAll patients underwent conventional CABG. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad; placebo group) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP.
Receives: Biological: 0.9% normal saline injection; Device: Implantable loop recorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug

    Measured: 1 year

Secondary outcomes (12)

  1. time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU

    Measured: 1 year

  2. post-CABG length of stay

    Measured: 12 months

  3. incidence of congestive heart failure

    Measured: 12 months

  4. incidence of sustained ventricular arrhythmias

    Measured: 12 months

  5. incidence of myocardial infarction

    Measured: 12 months

  6. incidence of renal failure

    Measured: 12 months

  7. incidence of respiratory failure

    Measured: 12 months

  8. stroke or transient ischemic attack

    Measured: 12 months

  9. rehospitalization

    Measured: 12 months

  10. readmission to ICU

    Measured: 12 months

  11. number of deaths

    Measured: 12 months

  12. post-CABG length of stay

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842529
Sponsor's protocol ID
BT13-01
Status last verified
Jan 2014
First submitted
22 Apr 2013
Last updated
31 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Romanov A, Pokushalov E, Ponomarev D, Bayramova S, Shabanov V, Losik D, Stenin I, Elesin D, Mikheenko I, Strelnikov A, Sergeevichev D, Kozlov B, Po SS, Steinberg JS. Long-term suppression of atrial fibrillation by botulinum toxin injection into epicardial fat pads in patients undergoing cardiac surgery: Three-year follow-up of a randomized study. Heart Rhythm. 2019 Feb;16(2):172-177. doi: 10.1016/j.hrthm.2018.08.019. Epub 2018 Nov 7.

    PubMed 30414841

  • Pokushalov E, Kozlov B, Romanov A, Strelnikov A, Bayramova S, Sergeevichev D, Bogachev-Prokophiev A, Zheleznev S, Shipulin V, Lomivorotov VV, Karaskov A, Po SS, Steinberg JS. Long-Term Suppression of Atrial Fibrillation by Botulinum Toxin Injection Into Epicardial Fat Pads in Patients Undergoing Cardiac Surgery: One-Year Follow-Up of a Randomized Pilot Study. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1334-41. doi: 10.1161/CIRCEP.115.003199. Epub 2015 Oct 20.

    PubMed 26486855

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing botulinum toxin injection, 0.9% normal saline injection and Implantable loop recorder in people with Paroxysmal Atrial Fibrillation and Indications for CABG, run by Meshalkin Research Institute of Pathology of Circulation at 3 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 9 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 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia, 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.

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?

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.

What does the primary outcome measure?

recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01842529, which also lists 2 linked publications.

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 31 Jan 2014.

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