Clinical trial NCT03723265: Personalized CRT - PSR
Official title: Personalized CRT - Product Surveillance Registry (PSR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 1517
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients that are or will be implanted with an eligible CRT system.

Brief summary: The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

Detailed description: The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.

Eligibility criteria: Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible CRT device
* Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/ or device study that may confound results

Primary outcomes:
measure: CRT Response
timeFrame: Every 3-9 months
Secondary outcomes:
measure: Treatments for CRT non-response
timeFrame: Every 3-9 months
measure: Treatment effects for different CRT features in the CRT non-responder population
timeFrame: Every 3-9 months
measure: Patient outcome post initial CRT implant
timeFrame: Every 3-9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Gilbert
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Redwood City
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: West Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Edgewood
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Clinton
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Robbinsdale
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Saint Louis Park
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Morristown
country: United States
state: New Jersey
city: Ocean Township
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Garden City
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Bethlehem
country: United States
state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wilkes-Barre
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Leuven
country: Belgium
city: Yvoir
country: Belgium
city: Calgary
country: Canada
city: Kingston
country: Canada
city: Montreal
country: Canada
city: Québec
country: Canada
city: Clermont-Ferrand
country: France
city: La Rochelle
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Pringy
country: France
city: Aachen
country: Germany
city: Essen
country: Germany
city: Hannover
country: Germany
city: Homburg
country: Germany
city: Köln
country: Germany
city: Tübingen
country: Germany
city: Ulm
country: Germany
city: Milano
country: Italy
city: Reggio Emilia
country: Italy
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur
country: Malaysia
city: Eindhoven
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Belgrade
country: Serbia
city: A Coruña
country: Spain
city: Palma de Mallorca
country: Spain
city: Skövde
country: Sweden
city: Birmingham
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
Study officials:
References: