Clinical trial NCT02232984: Quadripolar CRT-D On Currently Approved Lead SystemS
Official title: Quadripolar CRT-D On Currently Approved Lead SystemS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Cardiac Resynchronization Therapy (CRT)
CRT-D
Quadripolar pacing
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-09-08
Enrollment: 749
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: Number of Vectors With Phrenic Nerve Stimulation (PNS)
timeFrame: Pre-discharge (up to 7 days post implant)
Secondary outcomes:
measure: Final Pacing Treshold at Pre-discharge
timeFrame: Pre-discharge (up to 7 days post implant)
measure: Final LV Lead Impedance at Pre-discharge
timeFrame: Pre-discharge (up to 7 days post implant)
measure: Final Sensing Amplitude at Pre-discharge
timeFrame: Pre-discharge (up to 7 days post implant)
measure: Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
timeFrame: At time of implantation (0 to 30 days post consent signature)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular Medical Group
state: California
city: Los Angeles
country: United States
facility: Cardiac Device Rhythm Specialists, Inc
state: California
city: Palm Springs
country: United States
facility: Desert Heart Rhythm
state: California
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Florida VA
state: Florida
city: Jacksonville
country: United States
facility: Northeast Cardiology Clinic
state: Florida
city: Lakeland
country: United States
facility: Watson Center Clinic for Research
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart
state: Florida
city: Rockledge
country: United States
facility: Brevard Cardiovascular Res. Associates
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Sanford
country: United States
facility: Central Florida Regional
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hosptial
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Heart Specialist
state: Georgia
city: Augusta
country: United States
facility: AnMed Health
state: Georgia
city: Augusta
country: United States
facility: University Hospital
state: Georgia
city: Gainesville
country: United States
facility: North Georgia Heart Foundation
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Oak Park
country: United States
facility: West Suburban Hospital
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Shreveport
country: United States
facility: Ark-La-Tex Cardiology, APMC
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Flint
country: United States
facility: Hurley Hospital
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Medical Center
state: Michigan
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Medical Center
state: Michigan
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Las Vegas
country: United States
facility: Desert Springs
state: Nevada
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Atlantic City
country: United States
facility: Atlanticare Regional Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Mercy Hospital/ Buffalo Heart Group
state: New York
city: Zanesville
country: United States
facility: Genesis Health System
state: Ohio
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Newtown
country: United States
facility: Mercer Bucks Cardiology
state: Pennsylvania
city: Scranton
country: United States
facility: Regional Hospital of Scranton
state: Pennsylvania
city: Jackson
country: United States
facility: Core CV Research
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Arrhythmia Associates
state: Texas
city: Houston
country: United States
facility: Houston Cardiovascular Associates
state: Texas
city: Lufkin
country: United States
facility: Heart Institute of East Texas
state: Texas
city: The Woodlands
country: United States
facility: Woodlands North Houston Heart Ctr
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Richmond
country: United States
facility: Hunter Holmes VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Green Bay
country: United States
facility: Belin Healthcare
state: Wisconsin
Study officials:
affiliation: Vanderbilt University Medical Center, Nashville, TN
name: Christopher R Ellis, MD
role: PRINCIPAL_INVESTIGATOR
References: