Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2019 |
Start Date: | September 2009 |
End Date: | July 2012 |
Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study
The objective of this study is to assess the safety and efficacy of the Quartet™ lead and
Promote Q® device system in a patient population indicated for cardiac resynchronization
therapy.
Promote Q® device system in a patient population indicated for cardiac resynchronization
therapy.
Inclusion Criteria:
- Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for
treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
- Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker
implant with no prior LV lead placement.
- Ability to provide informed consent for study participation and is willing and able to
comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
- Have had a recent CVA or TIA within three months of enrollment
- Have a contraindication for an emergency thoracotomy
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or
short term contact with heparin
- Have a classification of Status 1 for cardiac transplantation or consideration for
transplantation over the next 3 months
- Have undergone a cardiac transplantation within 40 days of enrollment
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization
(PTCA, Stent or CABG) within 40 days of enrollment
- Are currently participating in a clinical investigation that includes an active
treatment arm
- Are pregnant or planning to become pregnant during the duration of the study
- Have a life expectancy of less than 6 months due to any condition
- Are less than 18 years of age
- Are unable to comply with the follow up schedule
We found this trial at
24
sites
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University of Southern California The University of Southern California is one of the world’s leading...
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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2901 West Kinnickinnic River Parkway
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
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Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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