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Heart FailureCROSS X4NCT02232984

Quadripolar CRT-D On Currently Approved Lead SystemS

An observational study of Heart Failure, run by Boston Scientific Corporation at 60 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate different ways to program around extracardiac stimulation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
749 participants
Where
60 sitesUnited States
Study dates
Oct 2014to Oct 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Atlanta Heart Specialist

    Atlanta, Georgia, 30342

  • Atlanticare Regional Medical Center

    Atlantic City, New Jersey, 08401

  • AnMed Health

    Augusta, Georgia, 29621

  • University Hospital

    Augusta, Georgia, 30901

  • Comprehensive Cardiovascular Medical Group

    Bakersfield, California, 93309

  • Bradenton Cardiology Center

    Bradenton, Florida, 34205

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Mercy Hospital/ Buffalo Heart Group

    Buffalo, New York, 14215

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Hurley Hospital

    Flint, Michigan, 48532

  • Lutheran Hospital

    Fort Wayne, Indiana, 46804

  • Parkview Hospital

    Fort Wayne, Indiana, 46843

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

  • North Florida VA

    Gainesville, Florida, 32610

  • North Georgia Heart Foundation

    Gainesville, Georgia, 30501

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Genesys Medical Center

    Grand Blanc, Michigan, 48439

  • Belin Healthcare

    Green Bay, Wisconsin, 54301

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Houston Arrhythmia Associates

    Houston, Texas, 77024

  • Houston Cardiovascular Associates

    Houston, Texas, 77030

  • Allegiance Health

    Jackson, Michigan, 49201

  • Core CV Research

    Jackson, Tennessee, 38305

  • Northeast Cardiology Clinic

    Jacksonville, Florida, 32216

  • Cardiology Associates of Northeast Arkansas

    Jonesboro, Arkansas, 72401

  • Watson Center Clinic for Research

    Lakeland, Florida, 33805

  • Desert Springs

    Las Vegas, Nevada, 89169

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72114

  • Cardiac Device Rhythm Specialists, Inc

    Los Angeles, California, 90033

  • Heart Institute of East Texas

    Lufkin, Texas, 75904

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Community Hospital

    Munster, Indiana, 46321

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Mercer Bucks Cardiology

    Newtown, Pennsylvania, 18940

  • West Suburban Hospital

    Oak Park, Illinois, 60302

  • Desert Heart Rhythm

    Palm Springs, California, 92262

  • Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona

    Phoenix, Arizona, 85006

  • St. Joseph's Hospital

    Phoenix, Arizona, 85013

  • Charlotte Heart

    Port Charlotte, Florida, 33952

  • Hunter Holmes VA Medical Center

    Richmond, Virginia, 23249

  • Brevard Cardiovascular Res. Associates

    Rockledge, Florida, 32955

  • Lakeland Medical Center

    Saint Joseph, Michigan, 49085

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Central Florida Regional

    Sanford, Florida, 32771

  • Sarasota Memorial Hosptial

    Sarasota, Florida, 34239

  • Regional Hospital of Scranton

    Scranton, Pennsylvania, 18510

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Ark-La-Tex Cardiology, APMC

    Shreveport, Louisiana, 71103

  • Willis Knighton

    Shreveport, Louisiana, 71105

  • Northside Hospital

    St. Petersburg, Florida, 33709

  • Tallahassee Memorial

    Tallahassee, Florida, 32308

  • Woodlands North Houston Heart Ctr

    The Woodlands, Texas, 17350

  • Central DuPage Medical Center

    Winfield, Illinois, 60190

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

  • Genesis Health System

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02232984
Study groupRoleWhat they receive
All study patientsAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre-discharge (up to 7 days post implant)

Secondary outcomes (4)

  1. 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.

    Measured: Pre-discharge (up to 7 days post implant)

  2. 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.

    Measured: Pre-discharge (up to 7 days post implant)

  3. 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.

    Measured: Pre-discharge (up to 7 days post implant)

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionApr 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
749 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02232984
Sponsor's protocol ID
CROSSX4
Acronym
CROSS X4
Status last verified
Oct 2018
First submitted
27 Aug 2014
Last updated
9 Apr 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Boston Scientific Corporation at 60 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Vectors With Phrenic Nerve Stimulation (PNS) (time frame: Pre-discharge (up to 7 days post implant)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02232984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.

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Quadripolar CRT-D On Currently Approved Lead SystemS | AzTrials