NCT00359203

ISSUE3: International Study on Syncope of Uncertain Etiology 3

ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.

Detailed description

In asystolic neurally-mediated syncope (NMS) documented by Implantable Loop recorder (ILR), ISSUE-2, an observational trial, showed that pacemaker was effective in reducing the 1-year first syncope recurrence rate from 33% rate before implant (ILR phase 1) to 5% rate after implant (phase 2). Moreover, the control non-asystolic group still continued to have a 41% recurrence rate after the first recurrence of syncope, thus supporting the conclusion that the reduction with pacemaker was due to the beneficial effect of pacemaker itself and not to other factors. However a formal controlled trial is needed to confirm these findings.

Conditions

• Syncope

Interventions

Type	Name	Description
DEVICE	Dual chamber pacemeker

Timeline

• Start date: 2006-09-01
• Primary completion: 2011-09-01
• Completion: 2012-11-01
• First posted: 2006-08-01
• Last updated: 2025-07-18
• Results posted: 2013-11-18

Locations

1 site across 1 country: Italy