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Trial record 1 of 1 for:    Quadripolar CRT-D On Currently Approved Lead SystemS
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Quadripolar CRT-D On Currently Approved Lead SystemS (CROSS X4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02232984
Recruitment Status : Completed
First Posted : September 8, 2014
Results First Posted : February 18, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease
Heart Failure

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Study Type : Observational
Actual Enrollment : 749 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quadripolar CRT-D On Currently Approved Lead SystemS
Actual Study Start Date : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : October 2016

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.



Primary Outcome Measures :
  1. Number of Vectors With Phrenic Nerve Stimulation (PNS) [ Time Frame: Pre-discharge (up to 7 days post implant) ]
    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.


Secondary Outcome Measures :
  1. Final Pacing Treshold at Pre-discharge [ Time Frame: Pre-discharge (up to 7 days post implant) ]
    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.

  2. Final LV Lead Impedance at Pre-discharge [ Time Frame: Pre-discharge (up to 7 days post implant) ]
    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.

  3. Final Sensing Amplitude at Pre-discharge [ Time Frame: Pre-discharge (up to 7 days post implant) ]
    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.

  4. Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems [ Time Frame: At time of implantation (0 to 30 days post consent signature) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232984


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Christopher R Ellis, MD Vanderbilt University Medical Center, Nashville, TN
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02232984    
Other Study ID Numbers: CROSSX4
First Posted: September 8, 2014    Key Record Dates
Results First Posted: February 18, 2019
Last Update Posted: April 9, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Scientific Corporation:
Heart Failure
Cardiac Resynchronization Therapy (CRT)
CRT-D
Quadripolar pacing
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases