- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771172
Acute Subcutaneous Defibrillation (ASQ)
October 10, 2016 updated by: Medtronic Cardiac Rhythm and Heart Failure
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minsk, Belarus
- Republican Scientific and Practical Center Cardiology
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Copenhagen, Denmark
- Rigshospitalet
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Nieuwegein, Netherlands
- St. Antonius Ziekenhuis
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Rotterdam, Netherlands
- Erasmus MC
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Bratislava, Slovakia, 83348
- Slovak Medical University
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Dudley, United Kingdom
- Dudley Group NHS-Russells Hall Hospital
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London, United Kingdom
- King's College Hospital
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Southhampton, United Kingdom
- Southhampton General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects may be either male or female, and must meet all of the inclusion criteria and none of the exclusion criteria of the study
Description
Inclusion Criteria:
- Subject must be undergoing implant of a commercially approved ICD system
- Subject must be willing to provide Informed Consent
- Subject must be > 18 years old
Exclusion Criteria:
- Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months)
- Subject has high risk of infection
- Subject has EF < 15%
- Subject at high risk of stroke
- having a device replacement
- Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
- Subject is indicated for CRT
- Subject is pacemaker dependent
- Subject enrolled in a concurrent study that may confound the results of this study
- Subject has medical conditions that would limit study participation
- Subject is pregnant
- Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
Time Frame: within the first day
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within the first day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 16, 2013
First Submitted That Met QC Criteria
January 16, 2013
First Posted (Estimate)
January 18, 2013
Study Record Updates
Last Update Posted (Estimate)
December 2, 2016
Last Update Submitted That Met QC Criteria
October 10, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASQ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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