Advance Cardiac Resynchronization Therapy (CRT) Registry

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805154
• Other study ID #: 60046199
• Status: Completed
• Start date: January 2013
• Est. completion date: September 2017

Study information

• Verified date: July 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1529
• Est. completion date: September 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  China,  Colombia,  India,  Japan,  Korea, Republic of,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response	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.; Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.)	6 months
Primary	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
Primary	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
Primary	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