QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Description

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).

Study Start Date

May, 19 2017

Estimated Completion Date

March 2019

Interventions

  • Device: MultiPole Pacing

Study ID

Biotronik, Inc. -- MPP Sub-Study

Status

Recruiting

Trial ID

NCT03155724

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

100

Sponsor

Biotronik, Inc.

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (182)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Lahey Hospital and Clinic - Burlington, Massachusetts 11.0 miles None None None
Lahey Hospital and Clinic - Burlington, Massachusetts 11.0 miles None None None
Lahey Hospital and Clinic - Burlington, Massachusetts 11.0 miles None None None
University of Massachusetts Medical School - Worcester, Massachusetts 34.2 miles None None None
University of Massachusetts Medical School - Worcester, Massachusetts 34.2 miles None None None
University of Massachusetts Medical School - Worcester, Massachusetts 34.2 miles None None None
Southcoast Health - Fall River, Massachusetts 44.9 miles None None None
Southcoast Health - Fall River, Massachusetts 44.9 miles None None None
Southcoast Health - Fall River, Massachusetts 44.9 miles None None None
Westchester Medical Center - Valhalla, New York 164.0 miles None None None
Westchester Medical Center - Valhalla, New York 164.0 miles None None None
Westchester Medical Center - Valhalla, New York 164.0 miles None None None
Montefiore Medical Center - The Bronx, New York 176.6 miles None None None
Montefiore Medical Center - The Bronx, New York 176.6 miles None None None
Montefiore Medical Center - The Bronx, New York 176.6 miles None None None
UVM Medical - Burlington, Vermont 179.4 miles None None None
UVM Medical - Burlington, Vermont 179.4 miles None None None
UVM Medical - Burlington, Vermont 179.4 miles None None None
Bryn Mawr Hospital - Bryn Mawr, Pennsylvania 179.8 miles None None None
New York Hospital Queens - Flushing, New York 179.8 miles None None None
Bryn Mawr Hospital - Bryn Mawr, Pennsylvania 179.8 miles None None None
Bryn Mawr Hospital - Bryn Mawr, Pennsylvania 179.8 miles None None None
New York Hospital Queens - Flushing, New York 179.8 miles None None None
New York Hospital Queens - Flushing, New York 179.8 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles None None None
Mt Sinai St Lukes Hospital - New York, New York 183.8 miles None None None
Mt Sinai St Lukes Hospital - New York, New York 183.8 miles None None None
Mt Sinai St Lukes Hospital - New York, New York 183.8 miles None None None
Weill Cornell Medicine - New York, New York 184.8 miles None None None
Weill Cornell Medicine - New York, New York 184.8 miles None None None
Weill Cornell Medicine - New York, New York 184.8 miles None None None
NYU Langone Medical Center - New York, New York 186.5 miles None None None
NYU Langone Medical Center - New York, New York 186.5 miles None None None
NYU Langone Medical Center - New York, New York 186.5 miles None None None
Northeast Cardiology - Bangor, Maine 206.0 miles None None None
Northeast Cardiology - Bangor, Maine 206.0 miles None None None
Northeast Cardiology - Bangor, Maine 206.0 miles None None None
Jersey Shore University Medical Center - Neptune City, New Jersey 214.3 miles None None None
Jersey Shore University Medical Center - Neptune City, New Jersey 214.3 miles None None None
Jersey Shore University Medical Center - Neptune City, New Jersey 214.3 miles None None None
Deborah Heart Lung Center - Browns Mills, New Jersey 245.5 miles None None None
Deborah Heart Lung Center - Browns Mills, New Jersey 245.5 miles None None None
Deborah Heart Lung Center - Browns Mills, New Jersey 245.5 miles None None None
Temple Heart and Vascular Institute - Philadelphia, Pennsylvania 266.2 miles None None None
Temple Heart and Vascular Institute - Philadelphia, Pennsylvania 266.2 miles None None None
Temple Heart and Vascular Institute - Philadelphia, Pennsylvania 266.2 miles None None None
MedStar Washington Hospital Center - Washington, District of Columbia 391.7 miles None None None
MedStar Washington Hospital Center - Washington, District of Columbia 391.7 miles None None None
MedStar Washington Hospital Center - Washington, District of Columbia 391.7 miles None None None
East Carolina Heart Institute at Eastern Carolina University - Greenville, North Carolina 577.7 miles None None None
East Carolina Heart Institute at Eastern Carolina University - Greenville, North Carolina 577.7 miles None None None
East Carolina Heart Institute at Eastern Carolina University - Greenville, North Carolina 577.7 miles None None None
Henry Ford Hospital - Detroit, Michigan 612.3 miles None None None
Henry Ford Hospital - Detroit, Michigan 612.3 miles None None None
Henry Ford Hospital - Detroit, Michigan 612.3 miles None None None
St Joseph Mercy Hospital - Ypsilanti, Michigan 640.8 miles None None None
St Joseph Mercy Hospital - Ypsilanti, Michigan 640.8 miles None None None
St Joseph Mercy Hospital - Ypsilanti, Michigan 640.8 miles None None None
OhioHealth Research Institute - Columbus, Ohio 640.9 miles None None None
OhioHealth Research Institute - Columbus, Ohio 640.9 miles None None None
OhioHealth Research Institute - Columbus, Ohio 640.9 miles None None None
The Ohio State University - Columbus, Ohio 641.8 miles None None None
The Ohio State University - Columbus, Ohio 641.8 miles None None None
The Ohio State University - Columbus, Ohio 641.8 miles None None None
University of Michigan Hospital - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Hospital - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Hospital - Ann Arbor, Michigan 645.2 miles None None None
ProMedica Physicians Cardiology - Toledo, Ohio 648.4 miles None None None
ProMedica Physicians Cardiology - Toledo, Ohio 648.4 miles None None None
ProMedica Physicians Cardiology - Toledo, Ohio 648.4 miles None None None
Wake Forest Baptist Health Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Wake Forest Baptist Health Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Wake Forest Baptist Health Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Forsynth Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Forsynth Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
Forsynth Medical Center - Winston-Salem, North Carolina 659.2 miles None None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles None None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles None None None
University of Cincinnati - Cincinnati, Ohio 737.6 miles None None None
Baptist Health - Lexington, Kentucky 771.2 miles None None None
Baptist Health - Lexington, Kentucky 771.2 miles None None None
Baptist Health - Lexington, Kentucky 771.2 miles None None None
Ashville Cardiology Associates - Asheville, North Carolina 774.5 miles None None None
Ashville Cardiology Associates - Asheville, North Carolina 774.5 miles None None None
Ashville Cardiology Associates - Asheville, North Carolina 774.5 miles None None None
Palmetto Health Richland - Columbia, South Carolina 786.3 miles None None None
Palmetto Health Richland - Columbia, South Carolina 786.3 miles None None None
Palmetto Health Richland - Columbia, South Carolina 786.3 miles None None None
St Francis Hospital - Greenville, South Carolina 802.1 miles None None None
St Francis Hospital - Greenville, South Carolina 802.1 miles None None None
St Francis Hospital - Greenville, South Carolina 802.1 miles None None None
AnMed Health - Anderson, South Carolina 827.4 miles None None None
AnMed Health - Anderson, South Carolina 827.4 miles None None None
AnMed Health - Anderson, South Carolina 827.4 miles None None None
The University of Chicago - Chicago, Illinois 848.0 miles None None None
The University of Chicago - Chicago, Illinois 848.0 miles None None None
The University of Chicago - Chicago, Illinois 848.0 miles None None None
UT Erlanger Cardiology - Chattanooga, Tennessee 917.8 miles None None None
UT Erlanger Cardiology - Chattanooga, Tennessee 917.8 miles None None None
UT Erlanger Cardiology - Chattanooga, Tennessee 917.8 miles None None None
Piedmont Heart Institute - Atlanta, Georgia 934.9 miles None None None
Piedmont Heart Institute - Atlanta, Georgia 934.9 miles None None None
Piedmont Heart Institute - Atlanta, Georgia 934.9 miles None None None
Christian Hospital - Saint Louis, Missouri 1,036.5 miles None None None
Christian Hospital - Saint Louis, Missouri 1,036.5 miles None None None
Christian Hospital - Saint Louis, Missouri 1,036.5 miles None None None
Washington University - Saint Louis, Missouri 1,039.5 miles None None None
Washington University - Saint Louis, Missouri 1,039.5 miles None None None
Washington University - Saint Louis, Missouri 1,039.5 miles None None None
St Louis Heart and Vascular - Saint Charles, Missouri 1,045.1 miles None None None
St Louis Heart and Vascular - Saint Charles, Missouri 1,045.1 miles None None None
St Louis Heart and Vascular - Saint Charles, Missouri 1,045.1 miles None None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,051.5 miles None None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,051.5 miles None None None
University of Iowa Hospitals and Clinics - Iowa City, Iowa 1,051.5 miles None None None
North Mississippi Medical Center - Tupelo, Mississippi 1,108.6 miles None None None
North Mississippi Medical Center - Tupelo, Mississippi 1,108.6 miles None None None
North Mississippi Medical Center - Tupelo, Mississippi 1,108.6 miles None None None
Florida Hospital - Orlando, Florida 1,115.8 miles None None None
Florida Hospital - Orlando, Florida 1,115.8 miles None None None
Florida Hospital - Orlando, Florida 1,115.8 miles None None None
Orlando Health - Orlando, Florida 1,118.6 miles None None None
Orlando Health - Orlando, Florida 1,118.6 miles None None None
Orlando Health - Orlando, Florida 1,118.6 miles None None None
Florida Hospital Tampa - Tampa, Florida 1,177.4 miles None None None
Florida Hospital Tampa - Tampa, Florida 1,177.4 miles None None None
Florida Hospital Tampa - Tampa, Florida 1,177.4 miles None None None
Baptist Hospital - Pensacola, Florida 1,217.6 miles None None None
Baptist Hospital - Pensacola, Florida 1,217.6 miles None None None
Baptist Hospital - Pensacola, Florida 1,217.6 miles None None None
Mercy Medical Research - Springfield, Missouri 1,228.8 miles None None None
Mercy Medical Research - Springfield, Missouri 1,228.8 miles None None None
Mercy Medical Research - Springfield, Missouri 1,228.8 miles None None None
Thomas Hospital - Fairhope, Alabama 1,240.2 miles None None None
Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
Research Medical Center - Kansas City, Missouri 1,249.4 miles None None None
University of Kansas Hospital - Kansas City, Missouri 1,251.3 miles None None None
University of Kansas Hospital - Kansas City, Missouri 1,251.3 miles None None None
University of Kansas Hospital - Kansas City, Missouri 1,251.3 miles None None None
Sanford Medical Center - Fargo, North Dakota 1,298.6 miles None None None
Sanford Medical Center - Fargo, North Dakota 1,298.6 miles None None None
Sanford Medical Center - Fargo, North Dakota 1,298.6 miles None None None
Ochsner Medical Center - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Medical Center - New Orleans, Louisiana 1,363.3 miles None None None
Ochsner Medical Center - New Orleans, Louisiana 1,363.3 miles None None None
Texas Health Heart and Vascular Hospital Arlington - Arlington, Texas 1,568.4 miles None None None
Texas Health Heart and Vascular Hospital Arlington - Arlington, Texas 1,568.4 miles None None None
Texas Health Heart and Vascular Hospital Arlington - Arlington, Texas 1,568.4 miles None None None
UT Health Science Center - The Woodlands, Texas 1,591.4 miles None None None
UT Health Science Center - The Woodlands, Texas 1,591.4 miles None None None
UT Health Science Center - The Woodlands, Texas 1,591.4 miles None None None
Cardiology Center of Amarillo - Amarillo, Texas 1,724.5 miles None None None
Cardiology Center of Amarillo - Amarillo, Texas 1,724.5 miles None None None
Cardiology Center of Amarillo - Amarillo, Texas 1,724.5 miles None None None
Cheyenne Cardiology - Cheyenne, Wyoming 1,731.6 miles None None None
Cheyenne Cardiology - Cheyenne, Wyoming 1,731.6 miles None None None
Cheyenne Cardiology - Cheyenne, Wyoming 1,731.6 miles None None None
Aurora Denver Cardiology Associates - Aurora, Colorado 1,760.5 miles None None None
Aurora Denver Cardiology Associates - Aurora, Colorado 1,760.5 miles None None None
Aurora Denver Cardiology Associates - Aurora, Colorado 1,760.5 miles None None None
STAR Clinical Trials - San Antonio, Texas 1,768.2 miles None None None
STAR Clinical Trials - San Antonio, Texas 1,768.2 miles None None None
STAR Clinical Trials - San Antonio, Texas 1,768.2 miles None None None
Glacier View Medical Research Institute Cardiology - Kalispell, Montana 2,114.7 miles None None None
Glacier View Medical Research Institute Cardiology - Kalispell, Montana 2,114.7 miles None None None
Glacier View Medical Research Institute Cardiology - Kalispell, Montana 2,114.7 miles None None None
Eisenhower Desert Cardiology - Rancho Mirage, California 2,511.4 miles None None None
Eisenhower Desert Cardiology - Rancho Mirage, California 2,511.4 miles None None None
Eisenhower Desert Cardiology - Rancho Mirage, California 2,511.4 miles None None None
Charp Chula Vista Medical Center - Chula Vista, California 2,581.2 miles None None None
Charp Chula Vista Medical Center - Chula Vista, California 2,581.2 miles None None None
Charp Chula Vista Medical Center - Chula Vista, California 2,581.2 miles None None None
South Bay Electrophysiology - Inglewood, California 2,603.8 miles None None None
South Bay Electrophysiology - Inglewood, California 2,603.8 miles None None None
South Bay Electrophysiology - Inglewood, California 2,603.8 miles None None None
Alaska Heart and Vascular Institute - Anchorage, Alaska 3,372.7 miles None None None

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