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Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Pulmonary vein isolation
GP ablation guided by SUMO technology
ILR implantation
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients, age ≥ 18 and ≤ 80 years.
  2. Persistent AF (ECG documentation).
  3. Indication for AF ablation.
  4. LVEF ≥ 50%
  5. Able to provide written informed consent
  6. Able to comply with the requirements of the study

Exclusion Criteria:

  1. Reversible cause of atrial fibrillation
  2. Previous AF ablation therapy
  3. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
  4. 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)
  5. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
  6. 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
  7. Inability to undergo D-SPECT and CT imaging

Sites / Locations

  • State Research Institute of CIrculation Pathology Novosibirsk, Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PVI group

PVI+GP guided by SUMO technology group

Arm Description

Conventional PVI by circumferential antral ablation according to standard procedures.

Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology.

Outcomes

Primary Outcome Measures

Number of patients without AF/AFl/AT

Secondary Outcome Measures

Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%).
Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT.

Full Information

First Posted
June 30, 2015
Last Updated
July 2, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02492256
Brief Title
Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVI group
Arm Type
Active Comparator
Arm Description
Conventional PVI by circumferential antral ablation according to standard procedures.
Arm Title
PVI+GP guided by SUMO technology group
Arm Type
Experimental
Arm Description
Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology.
Intervention Type
Device
Intervention Name(s)
Pulmonary vein isolation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
GP ablation guided by SUMO technology
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ILR implantation
Intervention Description
Implantation the ECG loop recorder according to standard procedure
Primary Outcome Measure Information:
Title
Number of patients without AF/AFl/AT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%).
Time Frame
12 month
Title
Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Romanov, MD, PhD
Email
abromanov@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Nikitenko
Email
m_nikitenko@meshalkin.ru
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Denis Losik

12. IPD Sharing Statement

Learn more about this trial

Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF

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