Evaluation of Automatic Threshold Algorithms

NCT02097290 | Completed Results

• 2 other identifiers: CAPTIVATEIDE# G130241
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 36

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.

Conditions

Heart Failure

Keywords

Threshold algorithms; CRT-D

Outcome Measures

Primary Outcomes (5)

• Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate

  Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.

  3 months

• The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.

  Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: \|commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.

  1-month and 3-month follow-up visits

• The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.

  Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.

  1-month and 3-month follow up visits

• The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold

  Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:\|Ambulatory threshold - ECG threshold\| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V; if the ECG threshold is \> 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

  1-month and 3-month follow up visits

• The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold

  Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

  1-month and 3-month follow up visits

Secondary Outcomes (2)

• RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome

  3-month follow up visit

• LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome

  3-month follow up visit

Study Arms (1)

CRT-D

EXPERIMENTAL

For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Device: CRT-D

Interventions

CRT-D DEVICE

For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

CRT-D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (36)

Glendale Adventist Medical Center

Glendale, California, 91204, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Delray Medical Center

Atlantis, Florida, 33462, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

First Coast Cardiovascular

Jacksonville, Florida, 32216, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

University Community Hospital

Trinity, Florida, 34655, United States

Location

Winter Haven Hospital

Winter Haven, Florida, 33881, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

IU Health LaPorte

La Porte, Indiana, 46350, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52043, United States

Location

University of Iowa Hospitals and Clinics

Davenport, Iowa, 52803, United States

Location

Via-Christi Regional Medical Center

Wichita, Kansas, 67208, United States

Location

Norton Cardiovascular Associates

Louisville, Kentucky, 40205, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Steward St. Elizabeth's Medical Center of Boston, Inc.

Boston, Massachusetts, 02135, United States

Location

St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

Sparrow Health System

Lansing, Michigan, 48912, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Cox Health

Springfield, Missouri, 65807, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Summa Health System

Akron, Ohio, 44034, United States

Location

Lindner Center for Research and Education

Cincinnati, Ohio, 45219, United States

Location

St. Elizabeth Health Center

Poland, Ohio, 44514, United States

Location

Good Samaritan Hospital

Lebanon, Pennsylvania, 17042, United States

Location

University Medical Center-Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Seton Medical Center

Austin, Texas, 78705, United States

Location

Cardiology Clinic of San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University Health

Richmond, Virginia, 23298, United States

Location

PeaceHealth Southwest Medical

Vancouver, Washington, 98664, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The RVAT and LVAT endpoints are compared against a performance goal rather than to a randomized control arm.

Results Point of Contact

• Title: Gregory Voss
• Organization: Boston Scientific

Gregory.Voss@bsci.com

6515813068

Study Officials

• Kenneth Ellenbogen, MD

  Virginia Commonwealth University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 27, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2017
• Last Updated: April 19, 2018
• Results First Posted: September 1, 2017

Record last verified: 2018-01

Locations

US (36)