Clinical trial NCT01805154: Advance Cardiac Resynchronization Therapy (CRT) Registry
Official title: Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-03-06
Enrollment: 1529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HF patients with St. Jude Medical CRT devices

Brief summary: The intent of this registry is to understand comprehensive clinical care strategies for Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world clinical practice.

Detailed description: Patients who are implanted CRT devices will be enrolled in the study. Once implanted, all patients will be followed at every 3 months for the first 12 months from the implant. The responder/non-responder evaluation will occur at 6 months from the implant date. The criteria used for determining the response to CRT will be captured.

During the office follow-up visits, arrhythmic episode diagnoses, device data and stored electrogram will be collected. All clinical events such as hospitalization for heart failure (HF), all-cause hospitalizations, and all-cause death will also be collected. For patients who are non-responders to CRT, any re-optimization of the device, i.e., atrioventricular and ventricle-to-ventricle interval optimization, left ventricular (LV) lead repositioning and pacing vector reconfiguration as well as modified/new clinical therapies administered in an attempt to improve HF condition will be collected.

Eligibility criteria: Inclusion Criteria:

* Patient willing and able to sign informed consent
* Patients implanted with any market-approved St. Jude Medical CRT-D/P device with no prior LV lead placement

Exclusion Criteria:

* Are likely to undergo heart transplantation within the next 12 months
* Are less than 18 years of age
* Are pregnant or planning to become pregnant during the duration of the study
* Are currently participating in a clinical investigation that includes an active treatment arm
* Have a life expectancy of less than 6 months

Primary outcomes:
measure: Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response
timeFrame: 6 months
measure: Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT
timeFrame: 6 months
measure: Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months
timeFrame: Between 6 and 12 months
measure: Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months
timeFrame: Between 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Cardiovascular Group, P.C.
state: Alabama
city: Huntsville
country: United States
facility: *Heart Center Research, LLC.
state: Alabama
city: Glendale
country: United States
facility: Cardiovascular Consultants Ltd
state: Arizona
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular
state: California
city: Chula Vista
country: United States
facility: Chula Vista Cardiac Center
state: California
city: Northridge
country: United States
facility: Cardiac Rhythm Specialist
state: California
city: Santa Barbara
country: United States
facility: Claudio Bonometti MD, Inc
state: California
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute Research Foundation, LLC
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants - Baptist Campus
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Tampa
country: United States
facility: VA Medical Center - Tampa
state: Florida
city: Joliet
country: United States
facility: Heartland Cardiovascular Center
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Advocate Health and Hospitals Corporation
state: Illinois
city: Des Moines
country: United States
facility: Unitypoint
state: Iowa
city: Madisonville
country: United States
facility: Heart Care Associates PSC
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: Lansing
country: United States
facility: *Thoracic Cardio Healthcare Found. (aka Sparrow Research)
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Cherry Hill
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Zanesville
country: United States
facility: Genesis HealthCare System
state: Ohio
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Johnson City
country: United States
facility: Mountain States Medical Group Cardiology
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville Cardiovascular Research Group, LLC
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Dallas
country: United States
facility: North Texas Heart Center
state: Texas
city: Charlottesville
country: United States
facility: Martha Jefferson
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Cardiac Rhythm Specialists, S.C.
state: Wisconsin
city: Cheyenne
country: United States
facility: Cheyenne Cardiology Associates
state: Wyoming
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro para la Docencia e Inv. med.
state: Riodepl
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular Buenos Aires (ICBA)
state: Riodepl
city: Nova Lima
country: Brazil
facility: Biocor Instituto
state: Minas
city: Sao Paulo
country: Brazil
facility: Hospital Beneficiencia Portuguesa de Sao Paulo
state: Sao Pau
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao (InCor) - HCFMUSP
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The 2nd Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Medellin
country: Colombia
facility: APEX Foundation
state: Antioq
city: New Delhi
country: India
facility: Delhi Heart and Lung Institute
state: Delhi
city: New Delhi
country: India
facility: Escorts Heart Institute and Research Centre
state: Delhi
city: New Delhi
country: India
facility: Fortis Flt. Lt. Rajan Dhall Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Care Institute of Medical Sciences
state: Gujarat
city: Mumbai
country: India
facility: Holy Family Hospital and Medical Research Center
state: Mhrshtr
city: Pune
country: India
facility: Ruby Hall Clinic
state: Mhrshtr
city: Gurgaon
country: India
facility: Medanta - The Medicity Hospital
state: Nct Dlh
city: Amritsar
country: India
facility: Fortis Escorts Hospital
state: Punjab
city: Mohali
country: India
facility: Fortis Hospital
state: Punjab
city: Chennai
country: India
facility: The Madras Medical Mission
state: Tmlnadu
city: Toyoake
country: Japan
facility: Fujita Health University School of medicine
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka Prefecture
city: Chiba
country: Japan
facility: Chiba University
city: Daejeon
country: Korea, Republic of
facility: Eulji university Hospital Daejeon
state: Hoseo
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Sudogwn
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
state: Sudogwn
city: San Juan
country: Puerto Rico
facility: Heart Rhythm Management
Study officials:
affiliation: The Cleveland Clinic
name: Niraj Varma, MD
role: STUDY_CHAIR
References:
citation: Varma N, Wang JA, Jaswal A, Sethi KK, Kondo Y, Joung B, Yoo D, Auricchio A, Singh JP, Lee K, Gold MR. CRT Efficacy in "Mid-Range" QRS Duration Among Asians Contrasted to Non-Asians, and Influence of Height. JACC Clin Electrophysiol. 2022 Feb;8(2):211-221. doi: 10.1016/j.jacep.2021.09.012. Epub 2021 Nov 24.
citation: Varma N, Boehmer J, Bhargava K, Yoo D, Leonelli F, Costanzo M, Saxena A, Sun L, Gold MR, Singh J, Gill J, Auricchio A. Evaluation, Management, and Outcomes of Patients Poorly Responsive to Cardiac Resynchronization Device Therapy. J Am Coll Cardiol. 2019 Nov 26;74(21):2588-2603. doi: 10.1016/j.jacc.2019.09.043.