Arrhythmia Clinical Trial
— PULSEOfficial title:
Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
Verified date | May 2009 |
Source | Transoma Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Panama: Ministry of Health |
Study type | Interventional |
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | September 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > = 18 years at time of enrollment - Either of the following: 1. MI > 30 days prior to enrolment and LVEF < = 35% by echocardiography (or nuclear imaging as necessary) 2. Syncope of unknown etiology Exclusion Criteria: - Life expectancy < 12 months following enrollment - Active infection |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Panama | Hospital Paitilla | Panama city |
Lead Sponsor | Collaborator |
---|---|
Transoma Medical |
Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostically viable ECG signals | daily | No | |
Secondary | rate of device-related adverse events | 1, 6, and 12 months | Yes |
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