Advance Cardiac Resynchronization Therapy (CRT) Registry

NCT01805154 | Completed Results

• 1 other identifier: 60046199
• Study Type: observational
• Target: 1,529
• Locations: 9 countries
• Sites: 69

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response

  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

  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

  Between 6 and 12 months

• Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months

  Improvement in NYHA Class determined by improvement by at least 1 class.

  Between 6 and 12 months

Study Arms (1)

CRT patients

Patients who have received any market approved St Jude Medical CRT-D or CRT-P device

Device: CRT Patients

Interventions

CRT Patients DEVICE

This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.

Also known as: St Jude Medical, Any approved CRT device

CRT patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HF patients with St. Jude Medical CRT devices

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (69)

Alabama Cardiovascular Group, P.C.

Birmingham, Alabama, 35205, United States

Location

*Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Cardiovascular Consultants Ltd

Glendale, Arizona, 85306, United States

Location

Cardiovascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85298, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Comprehensive Cardiovascular

Bakersfield, California, 93309, United States

Location

Chula Vista Cardiac Center

Chula Vista, California, 91910, United States

Location

Cardiac Rhythm Specialist

Northridge, California, 91325, United States

Location

Claudio Bonometti MD, Inc

Santa Barbara, California, 93101, United States

Location

The Cardiac & Vascular Institute Research Foundation, LLC

Gainesville, Florida, 32605, United States

Location

Cardiology Consultants - Baptist Campus

Pensacola, Florida, 32501, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

VA Medical Center - Tampa

Tampa, Florida, 33612, United States

Location

Heartland Cardiovascular Center

Joliet, Illinois, 60451, United States

Location

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, 60181, United States

Location

Unitypoint

Des Moines, Iowa, 50316, United States

Location

Heart Care Associates PSC

Madisonville, Kentucky, 42431, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Cardiology Consultants of East Michigan

Flint, Michigan, 48532, United States

Location

*Thoracic Cardio Healthcare Found. (aka Sparrow Research)

Lansing, Michigan, 48912, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Lourdes Cardiology Services

Cherry Hill, New Jersey, 08043, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44094, United States

Location

Genesis HealthCare System

Zanesville, Ohio, 43701, United States

Location

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, 16502, United States

Location

Mountain States Medical Group Cardiology

Johnson City, Tennessee, 37601, United States

Location

Knoxville Cardiovascular Research Group, LLC

Knoxville, Tennessee, 37922, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

North Texas Heart Center

Dallas, Texas, 75231, United States

Location

Martha Jefferson

Charlottesville, Virginia, 22911, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Cardiac Rhythm Specialists, S.C.

Milwaukee, Wisconsin, 53202, United States

Location

Cheyenne Cardiology Associates

Cheyenne, Wyoming, 82001, United States

Location

Fundacion Favaloro para la Docencia e Inv. med.

Buenos Aires, Riodepl, Argentina

Location

Instituto Cardiovascular Buenos Aires (ICBA)

Buenos Aires, Riodepl, Argentina

Location

Biocor Instituto

Nova Lima, Minas Gerais, Brazil

Location

Hospital Beneficiencia Portuguesa de Sao Paulo

São Paulo, Sao Pau, Brazil

Location

Instituto do Coracao (InCor) - HCFMUSP

São Paulo, Brazil

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

The 2nd Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

APEX Foundation

Medellín, Antioq, Colombia

Location

Care Institute of Medical Sciences

Ahmedabad, Gujarat, India

Location

Holy Family Hospital and Medical Research Center

Mumbai, Mhrshtr, India

Location

Ruby Hall Clinic

Pune, Mhrshtr, India

Location

Delhi Heart and Lung Institute

New Delhi, National Capital Territory of Delhi, India

Location

Escorts Heart Institute and Research Centre

New Delhi, National Capital Territory of Delhi, India

Location

Fortis Flt. Lt. Rajan Dhall Hospital

New Delhi, National Capital Territory of Delhi, India

Location

Medanta - The Medicity Hospital

Gūrgaon, NCT DLH, India

Location

Fortis Escorts Hospital

Amritsar, Punjab, India

Location

Fortis Hospital

Mohali, Punjab, India

Location

The Madras Medical Mission

Chennai, Tmlnadu, India

Location

Fujita Health University School of medicine

Toyoake, Aichi-ken, Japan

Location

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Location

Chiba University

Chiba, Japan

Location

Heart Rhythm Management

San Juan, Puerto Rico

Location

Eulji university Hospital Daejeon

Daejeon, Hoseo, South Korea

Location

Samsung Medical Center

Seoul, Sudogwn, South Korea

Location

Yonsei University Health System

Seoul, Sudogwn, South Korea

Location

Related Publications (2)

• 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.

  PMID: 34838518 DERIVED

• 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.

  PMID: 31748196 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clay Cohorn, Clinical Program Director
• Organization: Abbott

clay.cohorn@abbott.com

972-309-8087

Study Officials

• Niraj Varma, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: March 6, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: September 1, 2017
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (10); PR (1); JP (4); CO (1); US (41); KR (3); AR (2); CN (4); BR (3)