Quadripolar CRT-D On Currently Approved Lead SystemS (CROSS X4)

The purpose of the study is to evaluate different ways to program around extracardiac stimulation.

Study Overview

• Status: Completed
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Actual): 749

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Mercy Gilbert Medical Center
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital
    • Phoenix, Arizona, United States, 85006
      • Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona
    • Yuma, Arizona, United States, 85364
      • Yuma Regional Medical Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Cardiology Associates of Northeast Arkansas
    • Little Rock, Arkansas, United States, 72114
      • Central Arkansas Veterans Healthcare System
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Cardiovascular Medical Group
    • Los Angeles, California, United States, 90033
      • Cardiac Device Rhythm Specialists, Inc
    • Palm Springs, California, United States, 92262
      • Desert Heart Rhythm
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology Center
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Gainesville, Florida, United States, 32610
      • North Florida VA
    • Jacksonville, Florida, United States, 32216
      • Northeast Cardiology Clinic
    • Lakeland, Florida, United States, 33805
      • Watson Center Clinic for Research
    • Port Charlotte, Florida, United States, 33952
      • Charlotte Heart
    • Rockledge, Florida, United States, 32955
      • Brevard Cardiovascular Res. Associates
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
    • Sanford, Florida, United States, 32771
      • Central Florida Regional
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hosptial
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Atlanta Heart Specialist
    • Augusta, Georgia, United States, 30901
      • University Hospital
    • Augusta, Georgia, United States, 29621
      • AnMed Health
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
    • Gainesville, Georgia, United States, 30501
      • North Georgia Heart Foundation
  • Illinois
    • Oak Park, Illinois, United States, 60302
      • West Suburban Hospital
    • Winfield, Illinois, United States, 60190
      • Central DuPage Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Hospital
    • Fort Wayne, Indiana, United States, 46843
      • Parkview Hospital
    • Munster, Indiana, United States, 46321
      • Community Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Ark-La-Tex Cardiology, APMC
    • Shreveport, Louisiana, United States, 71105
      • Willis Knighton
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
    • Flint, Michigan, United States, 48532
      • Hurley Hospital
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Medical Center
    • Jackson, Michigan, United States, 49201
      • Allegiance Health
    • Saint Joseph, Michigan, United States, 49085
      • Lakeland Medical Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Desert Springs
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Atlantic City, New Jersey, United States, 08401
      • AtlantiCare Regional Medical Center
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • Buffalo, New York, United States, 14215
      • Mercy Hospital/ Buffalo Heart Group
  • Ohio
    • Zanesville, Ohio, United States, 43701
      • Genesis Health System
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Newtown, Pennsylvania, United States, 18940
      • Mercer Bucks Cardiology
    • Scranton, Pennsylvania, United States, 18510
      • Regional Hospital of Scranton
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Core CV Research
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Cardiovascular Associates
    • Houston, Texas, United States, 77024
      • Houston Arrhythmia Associates
    • Lufkin, Texas, United States, 75904
      • Heart Institute of East Texas
    • The Woodlands, Texas, United States, 17350
      • Woodlands North Houston Heart Ctr
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes VA Medical Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Belin Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be selected from the center's general population who are indicated for a CRT-D. All study subjects will be implanted with the BSC DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D). Subjects may have a previously implanted/will be receiving an approved quadripolar left ventricular lead.

Description

Inclusion Criteria:

• Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted with/scheduled to receive a commercially available quadripolar left ventricular lead
• Subject is willing and capable of providing informed consent and participating in all testing and study visits associated with this investigation at an approved center and at the intervals defined by this protocol
• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

• Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
• Subject is enrolled in any other concurrent study, without prior approval from BSC
• Women of childbearing potential who are or might be pregnant at the time of study enrollment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All study patients; All study patients will be implanted with a Boston Scientific (BSC) quadripolar Cardiac Resynchronization Therapy (CRT-D) and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Vectors With Phrenic Nerve Stimulation (PNS)	The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.	Pre-discharge (up to 7 days post implant)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final Pacing Treshold at Pre-discharge	Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.	Pre-discharge (up to 7 days post implant)
Final LV Lead Impedance at Pre-discharge	Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.	Pre-discharge (up to 7 days post implant)
Final Sensing Amplitude at Pre-discharge	Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.	Pre-discharge (up to 7 days post implant)
Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems	Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.	At time of implantation (0 to 30 days post consent signature)

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Christopher R Ellis, MD, Vanderbilt University Medical Center, Nashville, TN

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Heart Failure; CRT-D; Quadripolar pacing; Cardiac Resynchronization Therapy (CRT)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CROSSX4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No