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

Phase 2

• Conditions: Atrial Fibrillation
• Interventions: Device: Pulmonary vein isolation; Device: GP ablation guided by SUMO technology; Device: ILR implantation

• Registration Number: NCT02492256
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-30
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Study First Posted: 2015-07-08
• Last Update Posted: 2015-07-08
• Primary Completion: 2016-05
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI group	ILR implantation	Conventional PVI by circumferential antral ablation according to standard procedures.
PVI+GP guided by SUMO technology group	ILR implantation	Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology.
PVI group	Pulmonary vein isolation	Conventional PVI by circumferential antral ablation according to standard procedures.
PVI+GP guided by SUMO technology group	GP ablation guided by SUMO technology	Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology.

Primary Outcome Measures

Name	Time	Method
Number of patients without AF/AFl/AT	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation; 🇷🇺 Novosibirsk, Russian Federation