Personalized CRT - MPP Post Approval Study

Heart Failure Clinical Trial

Official title:

Personalized CRT - Multiple Point Pacing Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232944
• Other study ID #: MPP PAS
• Status: Completed
• Start date: July 5, 2017
• Est. completion date: January 7, 2021

Study information

• Verified date: February 2021
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1338
• Est. completion date: January 7, 2021
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy - MPP
The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Malaysia,  Netherlands,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPP therapy responder	To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".	Up to 3 years
Secondary	HF hospitalization and/or mortality	Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled	Up to 3 years