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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Atrial Fibrillation

Treatments: Device: GP ablation guided by SUMO technology; Device: Pulmonary vein isolation; Device: ILR implantation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02492256

SPT15429

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

PVI group

Active Comparator group

Description:

Conventional PVI by circumferential antral ablation according to standard procedures.

Treatment:

Device: ILR implantation

Device: Pulmonary vein isolation

PVI+GP guided by SUMO technology group

Experimental group

Description:

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

Treatment:

Device: GP ablation guided by SUMO technology

Device: ILR implantation