Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation

Status unconfirmed · Phase 2

Conditions studied: Persistent Atrial Fibrillation

In brief

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. Results were assessed with the use of an implanted monitoring device (IMD).

Key facts

Study ID

NCT02008448

Run by

Meshalkin Research Institute of Pathology of Circulation

People needed

160

Starts

2013-06-01

Expected to finish

2016-01-01

Last updated by the study team

2015-09-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Persistent and longstanding persistent AF

You may not qualify if…

• congestive heart failure
• LV ejection fraction < 35%
• left atrial diameter > 60 mm

Where it is running

• State Research Institute of Circulation Pathology — Novosibirsk, Russia (enrolling)
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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