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
8 Richland Medical Park Drive
Columbia, South Carolina 29203
Columbia, South Carolina 29203
Click here to add this to my saved trials
Click here to add this to my saved trials
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
Click here to add this to my saved trials
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Click here to add this to my saved trials
Click here to add this to my saved trials
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
115 Heart Drive
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Click here to add this to my saved trials
Click here to add this to my saved trials
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Florida Hospital Florida Hospital is one of the country
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials