MultiPoint Pacing IDE Study

Completed · Phase 3

Conditions studied: Heart Failure

In brief

This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months. The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.

Key facts

Study ID

NCT01786993

Run by

Abbott Medical Devices

People needed

506

Starts

2013-04-01

Expected to finish

2016-06-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s)
• Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
• Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

You may not qualify if…

• Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment
• Have an existing Class I recalled lead
• Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
• Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months
• Have permanent atrial fibrillation (AF)
• Have undergone a cardiac transplantation within 40 days of enrollment
• Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant.
• Are currently participating in a clinical investigation that includes an active treatment arm
• Are pregnant or planning to become pregnant during the duration of the study
• Have a life expectancy of less than 9 months due to any condition
• Are less than 18 years of age

Where it is running

• Heart Center Research, LLC. — Huntsville, Alabama, United States
• Banner Heart Hospital — Mesa, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Glendale Memorial Hospital and Medical Center — Glendale, California, United States
• Scripps Green Hospital — La Jolla, California, United States
• Premier Cardiology, Inc — Newport Beach, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Sutter Memorial Hospital — Sacramento, California, United States
• Colorado Heart & Vascular, P.C. — Lakewood, Colorado, United States
• Cardiology Associates of Fairfield County, PC — Norwalk, Connecticut, United States
• Christiana Hospital — Newark, Delaware, United States
• Bay Area Cardiology Associates PA — Brandon, Florida, United States
• Watson Clinic Center — Lakeland, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• St. Joseph's Hospital — Atlanta, Georgia, United States
• HeartCare Midwest — Peoria, Illinois, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Thoracic Cardio Healthcare Foundation — Lansing, Michigan, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• St. Luke's Hospital — Kansas City, Missouri, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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