Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/5/2018 |
Start Date: | March 2014 |
End Date: | September 2022 |
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4
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.
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.
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.
We found this trial at
96
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
University of Chicago One of the world's premier academic and research institutions, the University of...
Click here to add this to my saved trials
Medical City Dallas Hospital If you have concerns for your health, that of a family...
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
Click here to add this to my saved trials
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
Click here to add this to my saved trials
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
Click here to add this to my saved trials
Click here to add this to my saved trials
Emory University Hospital As the largest health care system in Georgia and the only health...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
Click here to add this to my saved trials
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
Click here to add this to my saved trials
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
Click here to add this to my saved trials
Click here to add this to my saved trials
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
Click here to add this to my saved trials
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
Click here to add this to my saved trials
Click here to add this to my saved trials
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials