Quadripolar CRT-D On Currently Approved Lead SystemS

Heart Failure Clinical Trial

— CROSS X4  

Official title:

Quadripolar CRT-D On Currently Approved Lead SystemS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232984
• Other study ID #: CROSSX4
• Status: Completed
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 749
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Heart Specialist	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Atlanticare Regional Medical Center	Atlantic City	New Jersey
United States	AnMed Health	Augusta	Georgia
United States	University Hospital	Augusta	Georgia
United States	Comprehensive Cardiovascular Medical Group	Bakersfield	California
United States	Bradenton Cardiology Center	Bradenton	Florida
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Mercy Hospital/ Buffalo Heart Group	Buffalo	New York
United States	The University of Vermont Medical Center	Burlington	Vermont
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Hurley Hospital	Flint	Michigan
United States	Lutheran Hospital	Fort Wayne	Indiana
United States	Parkview Hospital	Fort Wayne	Indiana
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	North Florida VA	Gainesville	Florida
United States	North Georgia Heart Foundation	Gainesville	Georgia
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Genesys Medical Center	Grand Blanc	Michigan
United States	Belin Healthcare	Green Bay	Wisconsin
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Houston Arrhythmia Associates	Houston	Texas
United States	Houston Cardiovascular Associates	Houston	Texas
United States	Allegiance Health	Jackson	Michigan
United States	Core CV Research	Jackson	Tennessee
United States	Northeast Cardiology Clinic	Jacksonville	Florida
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Watson Center Clinic for Research	Lakeland	Florida
United States	Desert Springs	Las Vegas	Nevada
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas
United States	Cardiac Device Rhythm Specialists, Inc	Los Angeles	California
United States	Heart Institute of East Texas	Lufkin	Texas
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Community Hospital	Munster	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mercer Bucks Cardiology	Newtown	Pennsylvania
United States	West Suburban Hospital	Oak Park	Illinois
United States	Desert Heart Rhythm	Palm Springs	California
United States	Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona	Phoenix	Arizona
United States	St. Joseph's Hospital	Phoenix	Arizona
United States	Charlotte Heart	Port Charlotte	Florida
United States	Hunter Holmes VA Medical Center	Richmond	Virginia
United States	Brevard Cardiovascular Res. Associates	Rockledge	Florida
United States	Lakeland Medical Center	Saint Joseph	Michigan
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Northside Hospital	Saint Petersburg	Florida
United States	Central Florida Regional	Sanford	Florida
United States	Sarasota Memorial Hosptial	Sarasota	Florida
United States	Regional Hospital of Scranton	Scranton	Pennsylvania
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Ark-La-Tex Cardiology, APMC	Shreveport	Louisiana
United States	Willis Knighton	Shreveport	Louisiana
United States	Tallahassee Memorial	Tallahassee	Florida
United States	Woodlands North Houston Heart Ctr	The Woodlands	Texas
United States	Central DuPage Medical Center	Winfield	Illinois
United States	Yuma Regional Medical Center	Yuma	Arizona
United States	Genesis Health System	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Vectors With Phrenic Nerve Stimulation (PNS)	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.	Pre-discharge (up to 7 days post implant)
Secondary	Final Pacing Treshold at Pre-discharge	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.	Pre-discharge (up to 7 days post implant)
Secondary	Final LV Lead Impedance at Pre-discharge	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.	Pre-discharge (up to 7 days post implant)
Secondary	Final Sensing Amplitude at Pre-discharge	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.	Pre-discharge (up to 7 days post implant)
Secondary	Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems	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.	At time of implantation (0 to 30 days post consent signature)