Quadripolar CRT-D On Currently Approved Lead SystemS

NCT02232984 | Completed Results

• 1 other identifier: CROSSX4
• Study Type: observational
• Target: 749
• Locations: 1 country
• Sites: 60

Brief Summary

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

Conditions

Heart Failure

Keywords

Heart Failure; Cardiac Resynchronization Therapy (CRT); CRT-D; Quadripolar pacing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Final Pacing Treshold at Pre-discharge

  Pre-discharge (up to 7 days post implant)

• Final LV Lead Impedance at Pre-discharge

  Pre-discharge (up to 7 days post implant)

• Final Sensing Amplitude at Pre-discharge

  Pre-discharge (up to 7 days post implant)

• Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems

  At time of implantation (0 to 30 days post consent signature)

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (60)

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona

Phoenix, Arizona, 85006, United States

Location

St. Joseph's Hospital

Phoenix, Arizona, 85013, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Cardiology Associates of Northeast Arkansas

Jonesboro, Arkansas, 72401, United States

Location

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72114, United States

Location

Comprehensive Cardiovascular Medical Group

Bakersfield, California, 93309, United States

Location

Cardiac Device Rhythm Specialists, Inc

Los Angeles, California, 90033, United States

Location

Desert Heart Rhythm

Palm Springs, California, 92262, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

North Florida VA

Gainesville, Florida, 32610, United States

Location

Northeast Cardiology Clinic

Jacksonville, Florida, 32216, United States

Location

Watson Center Clinic for Research

Lakeland, Florida, 33805, United States

Location

Charlotte Heart

Port Charlotte, Florida, 33952, United States

Location

Brevard Cardiovascular Res. Associates

Rockledge, Florida, 32955, United States

Location

Central Florida Regional

Sanford, Florida, 32771, United States

Location

Sarasota Memorial Hosptial

Sarasota, Florida, 34239, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

Tallahassee Memorial

Tallahassee, Florida, 32308, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Atlanta Heart Specialist

Atlanta, Georgia, 30342, United States

Location

AnMed Health

Augusta, Georgia, 29621, United States

Location

University Hospital

Augusta, Georgia, 30901, United States

Location

North Georgia Heart Foundation

Gainesville, Georgia, 30501, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

West Suburban Hospital

Oak Park, Illinois, 60302, United States

Location

Central DuPage Medical Center

Winfield, Illinois, 60190, United States

Location

Lutheran Hospital

Fort Wayne, Indiana, 46804, United States

Location

Parkview Hospital

Fort Wayne, Indiana, 46843, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Ark-La-Tex Cardiology, APMC

Shreveport, Louisiana, 71103, United States

Location

Willis Knighton

Shreveport, Louisiana, 71105, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Hospital

Flint, Michigan, 48532, United States

Location

Genesys Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Lakeland Medical Center

Saint Joseph, Michigan, 49085, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

Desert Springs

Las Vegas, Nevada, 89169, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Atlanticare Regional Medical Center

Atlantic City, New Jersey, 08401, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mercy Hospital/ Buffalo Heart Group

Buffalo, New York, 14215, United States

Location

Genesis Health System

Zanesville, Ohio, 43701, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Mercer Bucks Cardiology

Newtown, Pennsylvania, 18940, United States

Location

Regional Hospital of Scranton

Scranton, Pennsylvania, 18510, United States

Location

Core CV Research

Jackson, Tennessee, 38305, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Houston Arrhythmia Associates

Houston, Texas, 77024, United States

Location

Houston Cardiovascular Associates

Houston, Texas, 77030, United States

Location

Heart Institute of East Texas

Lufkin, Texas, 75904, United States

Location

Woodlands North Houston Heart Ctr

The Woodlands, Texas, 17350, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Hunter Holmes VA Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Belin Healthcare

Green Bay, Wisconsin, 54301, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Eszter Pais
• Organization: Boston Scientific

eszter.pais@bsci.com

6515825307

Study Officials

• Christopher R Ellis, MD

  Vanderbilt University Medical Center, Nashville, TN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 8, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 9, 2019
• Results First Posted: February 18, 2019

Record last verified: 2018-10

Locations

US (60)