Quadripolar Pacing Post Approval Study
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | February 15, 2012 |
End Date: | March 15, 2019 |
The purpose of this post-approval study is to evaluate the acute and chronic performance of a
Quadripolar CRT-D device system in a patient population indicated for cardiac
resynchronization therapy (CRT).
Quadripolar CRT-D device system in a patient population indicated for cardiac
resynchronization therapy (CRT).
Quad PAS is a multi-center, post-approval study. Patients who meet inclusion/exclusion
criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left
ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30
days for any adverse events and then withdrawn from the study, or may have an implant
reattempted if the physician chooses to do so. Patients enrolled in the study will be
followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years).
After patients complete 60 months of follow-up, their participation in the study will be
terminated.
criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left
ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30
days for any adverse events and then withdrawn from the study, or may have an implant
reattempted if the physician chooses to do so. Patients enrolled in the study will be
followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years).
After patients complete 60 months of follow-up, their participation in the study will be
terminated.
Inclusion Criteria:
1. Approved indication per current American College of Cardiology/American Heart
Association/Heart Rhythm Society guidelines for implantation of a CRT-D system for
treatment of heart failure or life threatening ventricular tachyarrhythmia(s).
2. Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study
(Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar
CRT-D device system implant or are undergoing an upgrade from an existing implantable
cardioverter-defibrillator or pacemaker implant with no prior LV lead placement.
3. Have the ability to provide informed consent for study participation and be willing
and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
2. Have a life expectancy of less than 5 years due to any condition
3. Be less than 18 years of age
We found this trial at
71
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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