NCT02492256

Brief 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 technology improves the clinical outcome in patients with persistent AF.

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
60

participants targeted

Target at P25-P50 for phase_2 atrial-fibrillation

Timeline
Completed

Started Jun 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

June 30, 2015

Last Update Submit

July 2, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of patients without AF/AFl/AT

    12 months

Secondary Outcomes (2)

  • Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%).

    12 month

  • Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT.

    12 month

Study Arms (2)

PVI group

ACTIVE COMPARATOR

Conventional PVI by circumferential antral ablation according to standard procedures.

Device: Pulmonary vein isolationDevice: 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.

Device: GP ablation guided by SUMO technologyDevice: ILR implantation

Interventions

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.

PVI group
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.

PVI+GP guided by SUMO technology group
ILR implantationDEVICE

Implantation the ECG loop recorder according to standard procedure

PVI groupPVI+GP guided by SUMO technology group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander Romanov, MD, PhD

CONTACT

abromanov@mail.ru

Marina Nikitenko

CONTACT

m_nikitenko@meshalkin.ru

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 8, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

RU(1)