Clinical trial NCT02097290: Evaluation of Automatic Threshold Algorithms
Official title: CAPTure Information Via Automatic Threshold Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Threshold algorithms
CRT-D
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The objective of the CAPTIVATE Clinical Study is to gather data to establish the safety and effectiveness of the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features to support the regulatory approval of the AUTOGEN CRT-D family of devices.

Eligibility criteria: Inclusion Criteria:

1. Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
2. Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
3. Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
4. 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
5. Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

1. Subjects who have an implanted multipolar (\>2poles) left ventricular lead or who will receive a multipolar (\>2poles) left ventricular lead
2. Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
3. 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
4. Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
5. Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
6. Subjects with a RV or LV lead revision or extraction within 30 days of enrollment
7. Subjects with an implanted lead that is planned to be extracted during the study implant procedure
8. Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
9. Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
10. Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
11. Subjects with a life expectancy less than 6 months
12. Subjects with a prosthetic mechanical tricuspid heart valve
13. 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
14. 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
15. Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center

Primary outcomes:
measure: Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
timeFrame: 3 months
measure: The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
timeFrame: 1-month and 3-month follow-up visits
measure: The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
timeFrame: 1-month and 3-month follow up visits
measure: The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
timeFrame: 1-month and 3-month follow up visits
measure: The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
timeFrame: 1-month and 3-month follow up visits
Secondary outcomes:
measure: RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
timeFrame: 3-month follow up visit
measure: LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
timeFrame: 3-month follow up visit
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: Delray Medical Center
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Trinity
country: United States
facility: University Community Hospital
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: LaPorte
country: United States
facility: IU Health LaPorte
state: Indiana
city: Cedar Rapids
country: United States
facility: St. Luke's Hospital
state: Iowa
city: Davenport
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Wichita
country: United States
facility: Via-Christi Regional Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Cardiovascular Associates
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Boston
country: United States
facility: Steward St. Elizabeth's Medical Center of Boston, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Health System
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education
state: Ohio
city: Poland
country: United States
facility: St. Elizabeth Health Center
state: Ohio
city: Lebanon
country: United States
facility: Good Samaritan Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: University Medical Center-Greenville Memorial Hospital
state: South Carolina
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: San Antonio
country: United States
facility: Cardiology Clinic of San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Health
state: Virginia
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: Virginia Commonwealth University Medical Center
name: Kenneth Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
References: