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Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads (NAVIGATE X4)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02071173
First received: February 21, 2014
Last updated: August 28, 2014
Last verified: May 2014
  Purpose

The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.


Condition Intervention
Cardiac Resynchronization Therapy
Device: CRT-D, quadripolar coronary venous lead, defibrillation lead

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • ACUITY X4 Primary Safety [ Time Frame: Implant through 6 months ] [ Designated as safety issue: No ]
    Lead-related complication-free rate of ACUITY X4 from implant through 6 months post implant.

  • ACUITY X4 Primary Effectiveness 1 [ Time Frame: Implant through 3 months ] [ Designated as safety issue: No ]
    Pacing capture thresholds in the programmed configuration, evaluated at 3 months post-implant (Cohort 1 and 2). Responders are defined as subjects with PCT ≤ 2.5 V in the programmed configuration.

  • ACUITY X4 Primary Effectiveness 2 [ Time Frame: Implant through 3 months ] [ Designated as safety issue: No ]
    Pacing capture thresholds (PCT) in the proximal zone (E2, E3, or E4) for Cohort 1, analyzed at 3 Months post-implant.

  • RELIANCE 4-FRONT Primary Safety 1 [ Time Frame: Implant through 3 months ] [ Designated as safety issue: No ]
    Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant

  • RELIANCE 4-FRONT Safety Endpoint 2 [ Time Frame: 3 months through 24 months ] [ Designated as safety issue: No ]
    Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant

  • RELIANCE 4-FRONT Primary Effectiveness Endpoint [ Time Frame: Implant through 3 months ] [ Designated as safety issue: No ]
    Pacing Thresholds at 0.5 ms pulse width, analyzed at 3 Months Post-Implant


Secondary Outcome Measures:
  • ACUITY X4 Secondary Effectiveness Endpoint 1 [ Time Frame: implant through 3 months ] [ Designated as safety issue: No ]
    Sensed amplitude in the programmed configuration, analyzed at 3 Months post-implant

  • ACUITY X4 Secondary Effectiveness Endpoint 2 [ Time Frame: Implant through 3 months ] [ Designated as safety issue: No ]
    Pacing impedances in the programmed configuration, analyzed at 3 months post-implant.

  • RELIANCE 4-FRONT Secondary Safety Endpoint [ Time Frame: Within 30 days of implant ] [ Designated as safety issue: No ]
    Detection of Ventricular Tachyarrhythmia's (VT/VF) within 30 days of implant

  • RELIANCE 4-FRONT Secondary Effectiveness Endpoint 1 [ Time Frame: Implant through 3 months ] [ Designated as safety issue: No ]
    Sensed Amplitude, analyzed at 3 Months Post-Implant

  • RELIANCE 4-FRONT Secondary Effectiveness Endpoint 2 [ Time Frame: Implant through 3 months ] [ Designated as safety issue: No ]
    Pacing Impedance, analyzed at 3 Months Post-Implant

  • RELIANCE 4-FRONT Secondary Effectiveness Endpoint 3 [ Time Frame: Within 30 days of implant ] [ Designated as safety issue: No ]
    Ventricular Tachyarrhythmia (VT/VF) Shock Conversion, analyzed within 30 days of implant


Estimated Enrollment: 2242
Study Start Date: March 2014
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ACUITY X4/ RELIANCE 4-FRONT
CRT-D patients implanted/ attempted with an ACUITY X4 LV lead and implanted/ attempted with a RELIANCE 4-FRONT RV lead
Device: CRT-D, quadripolar coronary venous lead, defibrillation lead
Other Names:
  • ACUITY X4 quadripolar coronary venous lead
  • RELIANCE 4-FRONT defibrillation lead

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects included in the NAVIGATE X4 Clinical Study should be selected from the investigator's general patient population indicated for CRT-D implantation. Investigators are responsible for screening all potential subjects and selecting those who meet the eligibility criteria for the study

Criteria

Inclusion Criteria:

Subjects indicated for a CRT-D that fulfill one of the following 5 criteria[1]:

  1. Subject with LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms, and a NYHA class II, III or ambulatory IV symptoms on GDMT*
  2. Subject with LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT*
  3. Subject with LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ ambulatory class IV symptoms on GDMT*
  4. Subject with atrial fibrillation and LVEF less than or equal to 35% on GDMT* if a) the subject requires ventricular pacing or otherwise meets CRT criteria [listed here] and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT
  5. Subject on GDMT* who have LVEF less than or equal to 35% and are undergoing new device placement with anticipated requirement for significant (>40%) ventricular pacing *GDMT = Guideline-directed medical therapy (formerly known as optimal pharmaceutical therapy (OPT)), represents optimal medical therapy as defined by ACCF/ AHA guideline-recommended therapies (primarily Class I)

    • Subject is intended to receive the ACUITY X4 LV lead and RELIANCE 4-FRONT RV lead (optional in Study Phase 1) and BSC CRT-D with quad header as their initial (de novo) cardiac implants
    • Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing 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:

Subjects who meet any one of the following criteria will be excluded from this clinical study.

  • Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
  • Subject has a mechanical tricuspid heart valve
  • Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following:
  • Schedule of procedures for the Study (i.e. should not cause additional or missed visits);
  • Study outcome (i.e. involve medications that could affect the heart rate of the subject);
  • Conduct of the Study per GCP/ ISO 14155:2011/ 21 CFR 812, local regulations
  • Subject is currently on the active heart transplant list
  • Subject has a documented life expectancy of less than twelve months
  • Women of childbearing potential who are or might be pregnant at the time of study enrollment or CRT-D System implant (method of assessment upon physician's discretion)
  • Subjects currently requiring chronic dialysis *Sponsors of such studies/registries should be informed and Boston Scientific must be informed by the investigator about the parallel conduct of these projects in the subject and of the project's basic nature. The decision if a desired mandatory governmental registry or observational study/ registry is in conflict with this exclusion criterion is up to the enrolling investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071173

Contacts
Contact: Suneet Mittal, MD (201)-432-7837 mittsu@valleyhealth.com
Contact: Martin Burke, DO (773)-520-8322 mburke@medicine.bsd.uchicago.edu

  Show 70 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Suneet Mittal, MD The Valley Hospital
Principal Investigator: Martin Burke, DO University of Chicago
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02071173     History of Changes
Other Study ID Numbers: C1481
Study First Received: February 21, 2014
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 23, 2014