Clinical trial NCT03232944: Personalized CRT - MPP Post Approval Study
Official title: Personalized CRT - Multiple Point Pacing Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 1338
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 Quad system.

Brief summary: The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

Detailed description: Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.

The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.

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: MPP therapy responder
timeFrame: Up to 3 years
Secondary outcomes:
measure: HF hospitalization and/or mortality
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Saint Vincent Heart Clinic Arkansas
state: Arkansas
city: Chula Vista
country: United States
facility: Chula Vista Cardiac Center
state: California
city: Palm Springs
country: United States
facility: Desert Heart Rhythm Consultants
state: California
city: Torrance
country: United States
facility: COR Healthcare
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiology
state: Colorado
city: Denver
country: United States
facility: Denver Heart
state: Colorado
city: Lakewood
country: United States
facility: Colorado Heart and Vascular, PC
state: Colorado
city: Hollywood
country: United States
facility: Heart Rhythm Solutions
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Safety Harbor
country: United States
facility: Heart & Vascular Institute of Florida
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Bethesda
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation Inc
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Marquette
country: United States
facility: UP Health System - Marquette
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Heart and Vascular Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Henderson
country: United States
facility: HealthCare Partners Medical Group
state: Nevada
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Garden City
country: United States
facility: Island Cardiac Specialists
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Utica
country: United States
facility: Central New York Cardiology
state: New York
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Akron
country: United States
facility: Northeast Ohio Cardiovascular Specialists
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital Health Network
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Toledo
country: United States
facility: Mercy Health - Saint Vincent Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Spokane
country: United States
facility: Kootenai Heart Clinics Northwest
state: Washington
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Yvoir
country: Belgium
facility: CHU UCL Mont-Godinne - Dinant
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Institut de cardiologie et de pneumologie de Québec (IUCPQ)
state: Quebec
city: Brest
country: France
facility: CHRU Brest - Hôpital de la Cavale Blanche
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
city: La Rochelle
country: France
facility: CHRU La Rochelle
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Pringy
country: France
facility: Centre hospitalier de la région d'Annecy
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Köln
country: Germany
facility: St. Vinzenz-Hospital Köln
city: Tübingen
country: Germany
facility: Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Magyar Honvédség Honvédkorház
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara - National Heart Institute
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital Rotterdam
city: Kosice
country: Slovakia
facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
city: A Coruña
country: Spain
facility: Hospital Universitario da Coruña
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
city: Birmingham
country: United Kingdom
facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital - South Tees Hospitals NHS
Study officials:
References: