Heart Failure Clinical Trial

Advance Cardiac Resynchronization Therapy (CRT) Registry

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

1529

Study ID:

NCT01805154

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

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There are 40 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1529

Study ID:

NCT01805154

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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