NCT02002988

Brief Summary

The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left atrium for preventing drug-resistant paroxysmal atrial fibrillation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.6 years

First QC Date

December 2, 2013

Last Update Submit

September 21, 2015

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • serious adverse events

    1 year

Secondary Outcomes (1)

  • number of paroxysms

    1 year

Study Arms (1)

BT injection

EXPERIMENTAL
Procedure: endomyocardial BT injection

Interventions

endomyocardial BT injectionPROCEDURE
BT injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • drug-resistant PAF

You may not qualify if:

  • 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
  • Left ventricle ejection fraction \<35%
  • Left atrial diameter \>55 mm
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

RECRUITING

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Evgeny Pokushalov, MD, PhD

    State Research Institute of Circulation Pathology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evgeny Pokushalov, MD, PhD, FESC

CONTACT

+79139254858e.pokushalov@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 6, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

RU(1)