Evaluation of Automatic Threshold Algorithms

Completed · Not applicable

Conditions studied: Heart Failure

In brief

This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices.

Key facts

Study ID

NCT02097290

Run by

Boston Scientific Corporation

People needed

216

Starts

2014-04-01

Expected to finish

2017-05-01

Last updated by the study team

2018-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
• Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
• Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
• Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol
• Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

You may not qualify if…

• Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
• Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
• Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned
• Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
• Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
• Subjects with a RV or LV lead revision or extraction within 30 days of enrollment
• Subjects with an implanted lead that is planned to be extracted during the study implant procedure
• Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
• Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
• Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
• Subjects with a life expectancy less than 6 months
• Subjects with a prosthetic mechanical tricuspid heart valve
• Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time
• Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific
• Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center

Where it is running

• Glendale Adventist Medical Center — Glendale, California, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Delray Medical Center — Atlantis, Florida, United States
• St. Vincent's Medical Center — Jacksonville, Florida, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• First Coast Cardiovascular — Jacksonville, Florida, United States
• Orlando Regional Medical Center — Orlando, Florida, United States
• University Community Hospital — Trinity, Florida, United States
• Winter Haven Hospital — Winter Haven, Florida, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• IU Health LaPorte — La Porte, Indiana, United States
• St. Luke's Hospital — Cedar Rapids, Iowa, United States
• University of Iowa Hospitals and Clinics — Davenport, Iowa, United States
• Via-Christi Regional Medical Center — Wichita, Kansas, United States
• Norton Cardiovascular Associates — Louisville, Kentucky, United States
• University of Maryland Medical System — Baltimore, Maryland, United States
• Steward St. Elizabeth's Medical Center of Boston, Inc. — Boston, Massachusetts, United States
• St. John Hospital & Medical Center — Detroit, Michigan, United States
• Sparrow Health System — Lansing, Michigan, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• Cox Health — Springfield, Missouri, United States
• St. Patrick Hospital — Missoula, Montana, United States
• Rochester General Hospital — Rochester, New York, United States
• Wake Medical Center — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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