Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Medtronic Bakken Research Center |
---|---|
Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00359203 |
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.
Condition | Intervention | Phase |
---|---|---|
Syncope |
Device: pacemaker |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-Mediated Syncope |
Estimated Enrollment: | 710 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Active Comparator
Active pacemaker
|
Device: pacemaker
Any pacemaker model with Rate Drop Response algorhythm
|
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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Nicoletta Grovale | +39-3358200782 | nicoletta.grovale@medtronic.com |
Contact: Michele Brignole, MD | +39-0185329569 | mbrignole@asl4.liguria.it |
Italy | |
Medtronic Italia S.p.A. | Recruiting |
Rome, Italy, 00193 | |
Contact: Nicoletta Grovale +390632814205 nicoletta.grovale@medtronic.com |
Principal Investigator: | Michele Brignole, MD | Ospedali del Tigullio, Lavagna |
Responsible Party: | Ospedali del Tigullio, Lavagna ( Michele Brignole ) |
Study ID Numbers: | ISS3 |
Study First Received: | July 31, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00359203 |
Health Authority: | Italy: Ministry of Health |
syncope implantable loop recorder |
Signs and Symptoms Unconsciousness Consciousness Disorders Neurologic Manifestations |
Heart Arrest Neurobehavioral Manifestations Syncope |
Nervous System Diseases |