Quadripolar CRT-D On Currently Approved Lead SystemS
- Conditions
- Heart Failure
- Registration Number
- NCT02232984
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 749
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Vectors With Phrenic Nerve Stimulation (PNS) 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
Name Time Method Final LV Lead Impedance at Pre-discharge 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.
Final Pacing Treshold at Pre-discharge 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.
Final Sensing Amplitude at Pre-discharge 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.
Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems 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.
Trial Locations
- Locations (60)
Comprehensive Cardiovascular Medical Group
🇺🇸Bakersfield, California, United States
Woodlands North Houston Heart Ctr
🇺🇸The Woodlands, Texas, United States
Cardiac Device Rhythm Specialists, Inc
🇺🇸Los Angeles, California, United States
Charlotte Heart
🇺🇸Port Charlotte, Florida, United States
Houston Arrhythmia Associates
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Cardiology Associates of Northeast Arkansas
🇺🇸Jonesboro, Arkansas, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Atlanticare Regional Medical Center
🇺🇸Atlantic City, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Northside Hospital
🇺🇸Saint Petersburg, Florida, United States
Central Florida Regional
🇺🇸Sanford, Florida, United States
Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Hurley Hospital
🇺🇸Flint, Michigan, United States
West Suburban Hospital
🇺🇸Oak Park, Illinois, United States
Genesys Medical Center
🇺🇸Grand Blanc, Michigan, United States
AnMed Health
🇺🇸Augusta, Georgia, United States
Ark-La-Tex Cardiology, APMC
🇺🇸Shreveport, Louisiana, United States
Yuma Regional Medical Center
🇺🇸Yuma, Arizona, United States
North Georgia Heart Foundation
🇺🇸Gainesville, Georgia, United States
Sarasota Memorial Hosptial
🇺🇸Sarasota, Florida, United States
Desert Springs
🇺🇸Las Vegas, Nevada, United States
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
University Hospital
🇺🇸Augusta, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
HealthEast St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Central DuPage Medical Center
🇺🇸Winfield, Illinois, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Willis Knighton
🇺🇸Shreveport, Louisiana, United States
Houston Cardiovascular Associates
🇺🇸Houston, Texas, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Lakeland Medical Center
🇺🇸Saint Joseph, Michigan, United States
Mercer Bucks Cardiology
🇺🇸Newtown, Pennsylvania, United States
Regional Hospital of Scranton
🇺🇸Scranton, Pennsylvania, United States
Core CV Research
🇺🇸Jackson, Tennessee, United States
Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona
🇺🇸Phoenix, Arizona, United States
St. Joseph's Hospital
🇺🇸Phoenix, Arizona, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Tallahassee Memorial
🇺🇸Tallahassee, Florida, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Atlanta Heart Specialist
🇺🇸Atlanta, Georgia, United States
Lutheran Hospital
🇺🇸Fort Wayne, Indiana, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
North Florida VA
🇺🇸Gainesville, Florida, United States
Desert Heart Rhythm
🇺🇸Palm Springs, California, United States
Watson Center Clinic for Research
🇺🇸Lakeland, Florida, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
Brevard Cardiovascular Res. Associates
🇺🇸Rockledge, Florida, United States
Bradenton Cardiology Center
🇺🇸Bradenton, Florida, United States
Mercy Hospital/ Buffalo Heart Group
🇺🇸Buffalo, New York, United States
Genesis Health System
🇺🇸Zanesville, Ohio, United States
Belin Healthcare
🇺🇸Green Bay, Wisconsin, United States
Hunter Holmes VA Medical Center
🇺🇸Richmond, Virginia, United States
Heart Institute of East Texas
🇺🇸Lufkin, Texas, United States
Northeast Cardiology Clinic
🇺🇸Jacksonville, Florida, United States