MultiPoint Pacing™ Post Market Study

Completed

Conditions studied: Heart Failure

In brief

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.

Key facts

Study ID

NCT02832622

Run by

Abbott Medical Devices

People needed

2169

Starts

2016-07-01

Expected to finish

2019-07-15

Last updated by the study team

2021-02-17

Who can join

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

You may qualify if…

• Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular 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…

• Are expected to receive a heart transplant during the duration of the study
• Have an epicardial ventricular lead system (Active or Inactive)
• Are less than 18 years of age
• Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
• Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care

Where it is running

• Heart Center Research, LLC. — Huntsville, Alabama, United States
• Integrated Medical Services — Avondale, Arizona, United States
• Cardiovascular Consultants Ltd — Glendale, Arizona, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
• John C. Lincoln North Mountain Hospital — Phoenix, Arizona, United States
• Arizona Arrhythmia Consultants — Scottsdale, Arizona, United States
• Comprehensive Cardiovascular Specialists — Alhambra, California, United States
• USC University Hospital — Los Angeles, California, United States
• Jeffrey Goodman — Los Angeles, California, United States
• Premier Cardiology, Inc — Newport Beach, California, United States
• Desert Heart Rhythm Consultants — Palm Springs, California, United States
• Chaparral Medical Group — Pomona, California, United States
• Cardiac Rhythm Specialists, Inc. — Reseda, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• COR Healthcare Medical Associates — Torrance, California, United States
• Aurora Denver Cardiology Associates, P.C. — Aurora, Colorado, United States
• Cardiology Associates of Fairfield County, PC — Norwalk, Connecticut, United States
• Cardiac Arrhythmia Services — Boca Raton, Florida, United States
• Yoel R. Vivas, MD — Delray Beach, Florida, United States
• Heart Rhythm Solutions — Hollywood, Florida, United States
• Citrus Cardiology Consultants, PA — Inverness, Florida, United States
• St. Vincent's Medical Center — Jacksonville, Florida, United States
• Naushad Shaik, MD — Kissimmee, Florida, United States
• University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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