Advance Cardiac Resynchronization Therapy (CRT) Registry

July 1, 2019 updated by: Abbott Medical Devices

Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1529

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Riodepl
      • Buenos Aires, Riodepl, Argentina
        • Fundacion Favaloro para la Docencia e Inv. med.
      • Buenos Aires, Riodepl, Argentina
        • Instituto Cardiovascular Buenos Aires (ICBA)
  • Brazil
      • Sao Paulo, Brazil
        • Instituto do Coracao (InCor) - HCFMUSP
    • Minas
      • Nova Lima, Minas, Brazil
        • Biocor Instituto
    • Sao Pau
      • Sao Paulo, Sao Pau, Brazil
        • Hospital Beneficiencia Portuguesa de Sao Paulo
  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui Provincial Hospital
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Provincial People's Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • The First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The 2nd Affiliated Hospital of Zhejiang University
  • Colombia
    • Antioq
      • Medellin, Antioq, Colombia
        • APEX Foundation
  • India
    • Delhi
      • New Delhi, Delhi, India
        • Delhi Heart and Lung Institute
      • New Delhi, Delhi, India
        • Escorts Heart Institute and Research Centre
      • New Delhi, Delhi, India
        • Fortis Flt. Lt. Rajan Dhall Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Care Institute of Medical Sciences
    • Mhrshtr
      • Mumbai, Mhrshtr, India
        • Holy Family Hospital and Medical Research Center
      • Pune, Mhrshtr, India
        • Ruby Hall Clinic
    • Nct Dlh
      • Gurgaon, Nct Dlh, India
        • Medanta - The Medicity Hospital
    • Punjab
      • Amritsar, Punjab, India
        • Fortis Escorts Hospital
      • Mohali, Punjab, India
        • Fortis Hospital
    • Tmlnadu
      • Chennai, Tmlnadu, India
        • The Madras Medical Mission
  • Japan
      • Chiba, Japan
        • Chiba University
    • Aichi
      • Toyoake, Aichi, Japan
        • Fujita Health University School of Medicine
    • Aomori
      • Hirosaki-shi, Aomori, Japan
        • Hirosaki University Hospital
    • Fukuoka Prefecture
      • Kitakyushu, Fukuoka Prefecture, Japan
        • Kokura Memorial Hospital
  • Korea, Republic of
    • Hoseo
      • Daejeon, Hoseo, Korea, Republic of
        • Eulji University Hospital Daejeon
    • Sudogwn
      • Seoul, Sudogwn, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Sudogwn, Korea, Republic of
        • Yonsei University Health System
  • Puerto Rico
      • San Juan, Puerto Rico
        • Heart Rhythm Management
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Cardiovascular Group, P.C.
      • Huntsville, Alabama, United States, 35801
        • *Heart Center Research, LLC.
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Cardiovascular Consultants Ltd
      • Mesa, Arizona, United States, 85206
        • CardioVascular Associates of Mesa
      • Phoenix, Arizona, United States, 85298
        • Phoenix Cardiovascular Research Group
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Cardiovascular
      • Chula Vista, California, United States, 91910
        • Chula Vista Cardiac Center
      • Northridge, California, United States, 91325
        • Cardiac Rhythm Specialist
      • Santa Barbara, California, United States, 93101
        • Claudio Bonometti MD, Inc
    • Florida
      • Gainesville, Florida, United States, 32605
        • The Cardiac & Vascular Institute Research Foundation, LLC
      • Pensacola, Florida, United States, 32501
        • Cardiology Consultants - Baptist Campus
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
      • Tampa, Florida, United States, 33612
        • VA Medical Center - Tampa
    • Illinois
      • Joliet, Illinois, United States, 60451
        • Heartland Cardiovascular Center
      • Oakbrook Terrace, Illinois, United States, 60181
        • Advocate Health and Hospitals Corporation
    • Iowa
      • Des Moines, Iowa, United States, 50316
        • Unitypoint
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Heart Care Associates PSC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02135
        • St. Elizabeth's Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • University of Michigan
      • Flint, Michigan, United States, 48532
        • Cardiology Consultants of East Michigan
      • Lansing, Michigan, United States, 48912
        • *Thoracic Cardio Healthcare Found. (aka Sparrow Research)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates of North Mississippi
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Hospital
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Cherry Hill, New Jersey, United States, 08043
        • Lourdes Cardiology Services
    • Ohio
      • Cleveland, Ohio, United States, 44094
        • The Cleveland Clinic Foundation
      • Zanesville, Ohio, United States, 43701
        • Genesis HealthCare System
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16502
        • Saint Vincent Consultants in Cardiovascular Diseases
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Mountain States Medical Group Cardiology
      • Knoxville, Tennessee, United States, 37922
        • Knoxville Cardiovascular Research Group, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia
      • Dallas, Texas, United States, 75231
        • North Texas Heart Center
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Martha Jefferson
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Cardiac Rhythm Specialists, S.C.
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Cardiology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HF patients with St. Jude Medical CRT devices

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRT patients
Patients who have received any market approved St Jude Medical CRT-D or CRT-P device
Device: CRT Patients
This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.
Other Names:
  • St Jude Medical, Any approved CRT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response
Time Frame: 6 months
  1. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score.
  2. Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.)
6 months
Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT
Time Frame: 6 months
Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.
6 months
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months
Time Frame: Between 6 and 12 months
Between 6 and 12 months
Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months
Time Frame: Between 6 and 12 months
Improvement in NYHA Class determined by improvement by at least 1 class.
Between 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: Niraj Varma, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (ESTIMATE)

March 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60046199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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