Advance Cardiac Resynchronization Therapy (CRT) Registry
- Conditions
- Heart Failure
- Interventions
- Device: CRT Patients
- Registration Number
- NCT01805154
- Lead Sponsor
- Abbott Medical 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1529
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CRT patients CRT Patients Patients who have received any market approved St Jude Medical CRT-D or CRT-P device
- Primary Outcome Measures
Name Time Method Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT 6 months Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.
Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months Between 6 and 12 months Improvement in NYHA Class determined by improvement by at least 1 class.
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 CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response 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.)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (69)
The Cleveland Clinic Foundation
๐บ๐ธCleveland, Ohio, United States
The Madras Medical Mission
๐ฎ๐ณChennai, Tmlnadu, India
Kokura Memorial Hospital
๐ฏ๐ตKitakyushu, Fukuoka Prefecture, Japan
Cardiovascular Associates of Mesa
๐บ๐ธMesa, Arizona, United States
Saint Vincent Consultants in Cardiovascular Diseases
๐บ๐ธErie, Pennsylvania, United States
Mountain States Medical Group Cardiology
๐บ๐ธJohnson City, Tennessee, United States
Jackson Heart Clinic
๐บ๐ธJackson, Mississippi, United States
Cardiology Associates of North Mississippi
๐บ๐ธTupelo, Mississippi, United States
Heart Rhythm Management
๐ต๐ทSan Juan, Puerto Rico
Guizhou Provincial People's Hospital
๐จ๐ณGuiyang, Guizhou, China
The 2nd Affiliated Hospital of Zhejiang University
๐จ๐ณHangzhou, Zhejiang, China
Cardiology Consultants of East Michigan
๐บ๐ธFlint, Michigan, United States
Heart Care Associates PSC
๐บ๐ธMadisonville, Kentucky, United States
Fortis Escorts Hospital
๐ฎ๐ณAmritsar, Punjab, India
Fortis Flt. Lt. Rajan Dhall Hospital
๐ฎ๐ณNew Delhi, Delhi, India
Holy Family Hospital and Medical Research Center
๐ฎ๐ณMumbai, Mhrshtr, India
Anhui Provincial Hospital
๐จ๐ณHefei, Anhui, China
Care Institute of Medical Sciences
๐ฎ๐ณAhmedabad, Gujarat, India
St. Louis University Hospital
๐บ๐ธSaint Louis, Missouri, United States
APEX Foundation
๐จ๐ดMedellin, Antioq, Colombia
Fundacion Favaloro para la Docencia e Inv. med.
๐ฆ๐ทBuenos Aires, Riodepl, Argentina
Hospital Beneficiencia Portuguesa de Sao Paulo
๐ง๐ทSao Paulo, Sao Pau, Brazil
Fujita Health University School of medicine
๐ฏ๐ตToyoake, Aichi, Japan
Hirosaki University Hospital
๐ฏ๐ตHirosaki-shi, Aomori, Japan
Fortis Hospital
๐ฎ๐ณMohali, Punjab, India
Yonsei University Health System
๐ฐ๐ทSeoul, Sudogwn, Korea, Republic of
Cheyenne Cardiology Associates
๐บ๐ธCheyenne, Wyoming, United States
Delhi Heart and Lung Institute
๐ฎ๐ณNew Delhi, Delhi, India
Escorts Heart Institute and Research Centre
๐ฎ๐ณNew Delhi, Delhi, India
The First Affiliated Hospital of Kunming Medical University
๐จ๐ณKunming, Yunnan, China
University of Mississippi Medical Center
๐บ๐ธJackson, Mississippi, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
St. Elizabeth's Medical Center
๐บ๐ธBoston, Massachusetts, United States
Minneapolis Heart Institute
๐บ๐ธMinneapolis, Minnesota, United States
University of Washington Medical Center
๐บ๐ธSeattle, Washington, United States
Instituto do Coracao (InCor) - HCFMUSP
๐ง๐ทSao Paulo, Brazil
Chiba University
๐ฏ๐ตChiba, Japan
*Heart Center Research, LLC.
๐บ๐ธHuntsville, Alabama, United States
Southern Arizona VA Health Care System
๐บ๐ธTucson, Arizona, United States
Comprehensive Cardiovascular
๐บ๐ธBakersfield, California, United States
Chula Vista Cardiac Center
๐บ๐ธChula Vista, California, United States
Tallahassee Research Institute
๐บ๐ธTallahassee, Florida, United States
Advocate Health and Hospitals Corporation
๐บ๐ธOakbrook Terrace, Illinois, United States
Heartland Cardiovascular Center
๐บ๐ธJoliet, Illinois, United States
Cardiovascular Consultants Ltd
๐บ๐ธGlendale, Arizona, United States
Cardiology Consultants - Baptist Campus
๐บ๐ธPensacola, Florida, United States
Cardiac Rhythm Specialist
๐บ๐ธNorthridge, California, United States
Lourdes Cardiology Services
๐บ๐ธCherry Hill, New Jersey, United States
Claudio Bonometti MD, Inc
๐บ๐ธSanta Barbara, California, United States
*Thoracic Cardio Healthcare Found. (aka Sparrow Research)
๐บ๐ธLansing, Michigan, United States
Deborah Heart and Lung Center
๐บ๐ธBrowns Mills, New Jersey, United States
Genesis HealthCare System
๐บ๐ธZanesville, Ohio, United States
Knoxville Cardiovascular Research Group, LLC
๐บ๐ธKnoxville, Tennessee, United States
North Texas Heart Center
๐บ๐ธDallas, Texas, United States
Martha Jefferson
๐บ๐ธCharlottesville, Virginia, United States
Eulji university Hospital Daejeon
๐ฐ๐ทDaejeon, Hoseo, Korea, Republic of
Instituto Cardiovascular Buenos Aires (ICBA)
๐ฆ๐ทBuenos Aires, Riodepl, Argentina
Biocor Instituto
๐ง๐ทNova Lima, Minas, Brazil
Samsung Medical Center
๐ฐ๐ทSeoul, Sudogwn, Korea, Republic of
Medanta - The Medicity Hospital
๐ฎ๐ณGurgaon, Nct Dlh, India
Alabama Cardiovascular Group, P.C.
๐บ๐ธBirmingham, Alabama, United States
Phoenix Cardiovascular Research Group
๐บ๐ธPhoenix, Arizona, United States
The Cardiac & Vascular Institute Research Foundation, LLC
๐บ๐ธGainesville, Florida, United States
VA Medical Center - Tampa
๐บ๐ธTampa, Florida, United States
Unitypoint
๐บ๐ธDes Moines, Iowa, United States
University of Michigan
๐บ๐ธAnn Arbor, Michigan, United States
Texas Cardiac Arrhythmia
๐บ๐ธAustin, Texas, United States
Cardiac Rhythm Specialists, S.C.
๐บ๐ธMilwaukee, Wisconsin, United States
Ruby Hall Clinic
๐ฎ๐ณPune, Mhrshtr, India