QP ExCELs: MultiPole Pacing (MPP) Sub-Study
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | May 19, 2017 |
End Date: | December 1, 2019 |
Contact: | Karlene Cox |
Email: | QPstudyteam@biotronik.com |
Phone: | 800-547-0394 |
The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to
demonstrate that the MPP feature is effective by converting a percentage of cardiac
resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a
single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).
demonstrate that the MPP feature is effective by converting a percentage of cardiac
resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a
single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).
Inclusion Criteria:
- Currently enrolled in the ongoing QP ExCELs study
- Successfully implanted with a BIOTRONIK Ilivia 7 HF-T QP family CRT-D system, or
future-marketed CRT-D system with the MPP feature. Successful implantation is defined
as having at least two LV pacing vectors with a measured pacing threshold of ≤ 5.0 V @
any pulse width (allowing for a minimum 2.5 V safety margin) without phrenic nerve
stimulation at the final programmed pacing output at the time of enrollment into the
MPP sub-study.
- CRT Responder Assessment classification as "Worsened" or "Unchanged"
- Standard continuous biventricular (BiV) pacing from implant until the 6-Month QP
ExCELs follow-up visit. (Implant to 3-Month QP ExCELs follow-up who qualify due to a
HF hospitalization event)
- Able to understand the nature of the sub-study and give informed consent
- Available for an additional follow-up visit specific to the MPP sub-study at the
investigational site
- No evidence of non-compliance to their ongoing commitment in the QP ExCELs study
Exclusion Criteria:
- Have a life expectancy of less than 6 months
- Expected to receive heart transplantation or ventricular assist device within 6 months
- Chronic atrial fibrillation
- Presence of another life-threatening, underlying illness separate from their cardiac
disorder
- Received MPP pacing prior to enrolment into the MPP sub-study
We found this trial at
67
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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8 Richland Medical Park Drive
Columbia, South Carolina 29203
Columbia, South Carolina 29203
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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115 Heart Drive
Greenville, North Carolina 27834
Greenville, North Carolina 27834
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Florida Hospital Florida Hospital is one of the country
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Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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