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Clinical Trials/NCT02492256
NCT02492256UnknownPhase 2

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 Circulation2 sites in 1 country60 target enrollmentStarted: June 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Number of patients without AF/AFl/AT
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (2)

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