Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:April 14, 2017
End Date:August 1, 2022
Contact:Sara Veraghtert
Email:sara.veraghtert@bsci.com
Phone:+32(0)478783897

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Trial Summary
Trial Overview
Inclusion Criteria

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population,
which optimization techniques are used and how effective they are. It will compare 12-month
response rates among different optimization methods and characterize which selected subject
subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up
(PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage
in a real world setting and monitor long term safety associated with these devices to support
CE Mark.


Inclusion Criteria:

- Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any
manufacturer quadripolar LV lead based on BSC labeling for devices in specific
geographies.

- Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation
procedure.

- Subject is age 18 or above, or of legal age to give informed consent specific to each
country and national laws

- Subject is willing and capable of complying with follow-up visits and procedures as
defined by this protocol

Exclusion Criteria:

- Subject with documented life expectancy of less than 12 months

- Subject currently on the active heart transplant list or has a current Left
Ventricular Assist Device or other assist device (mechanical circulatory support
device).

- Subject who have had a pre-existing CRT device

- Subject enrolled in any other concurrent clinical trial without prior written approval
from BSC Clinical Trial Manager

- Women of childbearing potential who are or might be pregnant at time of study
enrolment

- Any contra-indication to receive a CRT-D device per local guidelines
We found this trial at
31
sites
Sinai Hospital of Baltimore
2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Principal Investigator: Mohammed Kanjwal, Dr
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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St. Alexius Medical Center
931 S. 9th Street
Bismarck, North Dakota 58504
701-530-6954
Principal Investigator: Colby Halsy, Dr
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Bismarck, ND
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North Florida/South Georgia Veterans Health System
Gainesville, Florida 32608
Principal Investigator: Mark Panna, Dr.
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Gainesville, FL
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Abington Memorial Hospital
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: Charles Gottlieb, Dr.
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Abington, PA
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Alaska Heart and Vascular Institute
3831 Piper Street
Anchorage, Alaska 99508
Principal Investigator: Steve Compton, Dr.
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Anchorage, AK
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Comprehensive Cardiovascular Medical Group
Bakersfield, California 93309
Principal Investigator: Moksedul Habib, Dr
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Bakersfield, CA
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Flinders Medical Centre
Bedford Park, South Australia 5042
Principal Investigator: Andrew McGavin, Dr.
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Bedford Park,
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Summit Medical Group
Berkeley Heights, New Jersey 07922
Principal Investigator: Robert Altman, Dr.
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Berkeley Heights, NJ
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Bay Area Cardiology Associates, P.A.
Brandon, Florida 33511
Principal Investigator: Stephen Mester, Dr.
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from
Brandon, FL
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Trinity Medical WNY, PC
3050 Orchard Park Road
Buffalo, New York 14215
Principal Investigator: Prajwal Deshmukh, Dr.
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Buffalo, NY
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University of Illinois Hospital & Health Sciences System
Chicago, Illinois 60612
Principal Investigator: Erik Wissner, Dr
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Chicago, IL
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Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut 06810
Principal Investigator: Robert Winslow, Dr.
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Danbury, CT
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Midwest Cardiovascular Research Foundation
Davenport, Iowa 52803
Principal Investigator: Linda Hu, Dr.
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from
Davenport, IA
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Flint Cardiovascular Consultants
Flint, Michigan 48532
Principal Investigator: Samir Elian, Dr.
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from
Flint, MI
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North Georgia Heart Foundation
Gainesville, Georgia 30501
Principal Investigator: Salem Sayar, Dr.
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Gainesville, GA
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Texas Heart Rhythm
Houston, Texas 77074
Principal Investigator: Jie Cheng, Dr.
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from
Houston, TX
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St. Bernard's Medical Center
Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair, Dr.
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from
Jonesboro, AR
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Riverside Medical Center / Midwest Arrhythmia Consultants
350 N Wall St
Kankakee, Illinois 60901
Principal Investigator: Brad Supernant, Dr.
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Kankakee, IL
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Kettering Medical Center
3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Principal Investigator: Khawaja Shahid H Baig, Dr.
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Cardiovascular Institute of the South
Lafayette, Louisiana 70506
Principal Investigator: Marc Saad, Dr.
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from
Lafayette, LA
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VA Loma Linda Healthcare System
Loma Linda, California 92357
Principal Investigator: Ronald Lo, Dr.
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from
Loma Linda, CA
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McAllen Medical Heart Hospital
McAllen, Texas 78503
Principal Investigator: Eric Taylor, Dr.
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from
McAllen, TX
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Cardiovascular Associates of Mesa
Mesa, Arizona 85206
Principal Investigator: Andrew Kaplan, Dr.
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from
Mesa, AZ
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Ball Memorial Hospital
Muncie, Indiana 47303
Principal Investigator: Michael Moran, Dr
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from
Muncie, IN
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Columbia University Medical Center/NY Presbyterian Hospital
New York, New York 10032
Principal Investigator: Jose Dizon, Dr.
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New York, NY
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Cardiac & Vascular Research Centre of Northern Michigan
416 Connable Avenue
Petoskey, Michigan 49770
Principal Investigator: Daniel Buerkel, Dr.
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from
Petoskey, MI
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Hunter Holmes McGuire VA Medical Center
Richmond, Virginia 23249
Principal Investigator: Karoly Kaszala, Dr.
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from
Richmond, VA
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Peninsula Cardiology Associates
Salisbury, Maryland 21804
Principal Investigator: Nsah Emmanuel, Dr.
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from
Salisbury, MD
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STAR Clinical Trials LLC
San Antonio, Texas 78229
Principal Investigator: Carlos Roman, Dr.
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from
San Antonio, TX
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Regional Cardiac Arrythmia
Washington, Pennsylvania 15301
Principal Investigator: Maninder Bedi, Dr.
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from
Washington, PA
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New Hanover Regional Medical Center
Wilmington, North Carolina 28401
Principal Investigator: Meena Rao
Phone: 910-667-4044
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Wilmington, NC
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