Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

Completed · Not applicable

Conditions studied: Left Ventricular Dysfunction

In brief

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Key facts

Study ID

NCT03257436

Run by

Boston Scientific Corporation

People needed

586

Starts

2018-01-05

Expected to finish

2020-11-19

Last updated by the study team

2022-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
• Subjects must meet BSC labeled indication for CRT-D implantation.
• Subjects must have a functional RA lead and RV lead implanted
• Subjects who are willing and capable of providing informed consent
• Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
• Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

You may not qualify if…

• Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
• Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
• Subjects with documented history of permanent AF
• Subjects with documented permanent complete AV block
• Subjects who are expected to receive a heart transplant during the 12 months course of the study
• Subjects with documented life expectancy of less than 12 months
• Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC

Where it is running

• Phoenix Cardiovascular Group — Phoenix, Arizona, United States
• Cardiology Associates of NEA — Jonesboro, Arkansas, United States
• Foothill Cardiology Medical Group — Arcadia, California, United States
• Chula Vista Cardiac Center — Chula Vista, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Desert Heart Rhythm Consultants — Palm Springs, California, United States
• Cardiology Associates Medical Group — Ventura, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Delray Medical Center — Delray Beach, Florida, United States
• UF Health Jacksonville — Jacksonville, Florida, United States
• Florida Hospital Waterman — Lake Mary, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Alexian Brothers Hospital Network — Elk Grove Village, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Parkview Hospital Inc — Fort Wayne, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Heart Specialist — Louisville, Kentucky, United States
• Advanced Cardiovascular Specialists — Shreveport, Louisiana, United States
• MedStar Heart and Vascular Institute — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Ascension St. John Hospital & Medical Center — Detroit, Michigan, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• St. Mary's of Michigan Research Institute at Covenant Medical Ceter — Saginaw, Michigan, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.