Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Persistent Atrial Fibrillation Patients: Prospective Randomized Study

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country60 target enrollmentJune 2015

ConditionsAtrial Fibrillation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 60
Locations: 1
Primary Endpoint: Number of patients without AF/AFl/AT
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

August 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients, age ≥ 18 and ≤ 80 years.
•Persistent AF (ECG documentation).
•Indication for AF ablation.
•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

Outcomes

Primary Outcomes

Number of patients without AF/AFl/AT

Time Frame: 12 months

Secondary Outcomes

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)