Advance Cardiac Resynchronization Therapy (CRT) Registry

An observational study of Heart Failure, run by Abbott Medical Devices at 69 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: CRT Patients
Type of treatment: Medical device
How many people: 1,529 participants
Where: 69 sitesin 9 countries
Study dates: Jan 2013to Sep 2017
How long will I take part?: 12 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: HF patients with St. Jude Medical CRT devices

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

69 sites in 9 countries.

Country

City, postcode or hospital

69 sites in 9 countries

United States41 sites

University of Michigan
Ann Arbor, Michigan, 48104
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Comprehensive Cardiovascular
Bakersfield, California, 93309
Alabama Cardiovascular Group, P.C.
Birmingham, Alabama, 35205
Massachusetts General Hospital
Boston, Massachusetts, 02114
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Martha Jefferson
Charlottesville, Virginia, 22911
Lourdes Cardiology Services
Cherry Hill, New Jersey, 08043
Cheyenne Cardiology Associates
Cheyenne, Wyoming, 82001
Chula Vista Cardiac Center
Chula Vista, California, 91910
The Cleveland Clinic Foundation
Cleveland, Ohio, 44094
North Texas Heart Center
Dallas, Texas, 75231
Unitypoint
Des Moines, Iowa, 50316
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, 16502
Cardiology Consultants of East Michigan
Flint, Michigan, 48532
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville, Florida, 32605
Cardiovascular Consultants Ltd
Glendale, Arizona, 85306
*Heart Center Research, LLC.
Huntsville, Alabama, 35801
Jackson Heart Clinic
Jackson, Mississippi, 39216
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Mountain States Medical Group Cardiology
Johnson City, Tennessee, 37601
Heartland Cardiovascular Center
Joliet, Illinois, 60451
Knoxville Cardiovascular Research Group, LLC
Knoxville, Tennessee, 37922
*Thoracic Cardio Healthcare Found. (aka Sparrow Research)
Lansing, Michigan, 48912
Heart Care Associates PSC
Madisonville, Kentucky, 42431
Cardiovascular Associates of Mesa
Mesa, Arizona, 85206
Cardiac Rhythm Specialists, S.C.
Milwaukee, Wisconsin, 53202
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Cardiac Rhythm Specialist
Northridge, California, 91325
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, 60181
Cardiology Consultants - Baptist Campus
Pensacola, Florida, 32501
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85298
Claudio Bonometti MD, Inc
Santa Barbara, California, 93101
University of Washington Medical Center
Seattle, Washington, 98195
St. Louis University Hospital
St Louis, Missouri, 63110
Tallahassee Research Institute
Tallahassee, Florida, 32308
VA Medical Center - Tampa
Tampa, Florida, 33612
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
Genesis HealthCare System
Zanesville, Ohio, 43701

Other trials in United States

India10 sites

Care Institute of Medical Sciences
Ahmedabad, Gujarat
Fortis Escorts Hospital
Amritsar, Punjab
The Madras Medical Mission
Chennai, Tmlnadu
Medanta - The Medicity Hospital
Gūrgaon, NCT DLH
Fortis Hospital
Mohali, Punjab
Holy Family Hospital and Medical Research Center
Mumbai, Mhrshtr
Delhi Heart and Lung Institute
New Delhi, National Capital Territory of Delhi
Escorts Heart Institute and Research Centre
New Delhi, National Capital Territory of Delhi
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi
Ruby Hall Clinic
Pune, Mhrshtr

Other trials in India

China4 sites

Guizhou Provincial People's Hospital
Guiyang, Guizhou
The 2nd Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Anhui Provincial Hospital
Hefei, Anhui
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan

Other trials in China

Japan4 sites

Chiba University
Chiba
Hirosaki University Hospital
Hirosaki-shi, Aomori
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Fujita Health University School of medicine
Toyoake, Aichi-ken

Other trials in Japan

Brazil3 sites

Biocor Instituto
Nova Lima, Minas Gerais
Hospital Beneficiencia Portuguesa de Sao Paulo
São Paulo, Sao Pau
Instituto do Coracao (InCor) - HCFMUSP
São Paulo

Other trials in Brazil

South Korea3 sites

Eulji university Hospital Daejeon
Daejeon, Hoseo
Samsung Medical Center
Seoul, Sudogwn
Yonsei University Health System
Seoul, Sudogwn

Other trials in South Korea

Argentina2 sites

Fundacion Favaloro para la Docencia e Inv. med.
Buenos Aires, Riodepl
Instituto Cardiovascular Buenos Aires (ICBA)
Buenos Aires, Riodepl

Other trials in Argentina

Colombia1 site

APEX Foundation
Medellín, Antioq

Other trials in Colombia

Puerto Rico1 site

Heart Rhythm Management
San Juan

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Conditions: Heart Failure
Being tested: CRT Patients
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRT PatientsDevice
Also called St Jude Medical, Any approved CRT device
This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.

Study groups in NCT01805154
Study group	Role	What they receive
CRT patients		Patients who have received any market approved St Jude Medical CRT-D or CRT-P device Receives: Device: CRT Patients

What is being measured

The primary outcome is the main question the study is designed to answer.

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.)
Measured: 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.
Measured: 6 months
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months
Measured: 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.
Measured: Between 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Sep 2017

First posted6 Mar 2013 (estimated)
Study startJan 2013
Primary completionNov 2016
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,529 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT01805154
Sponsor's protocol ID: 60046199
Status last verified: Jul 2019
First submitted: 14 Feb 2013
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 34838518
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.
PubMed 31748196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
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Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
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Enrolling by invitationObservational study
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All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders
ClinicalTrials.gov ID: NCT01805154
Acronym / sponsor ID: 60046199
Conditions: Heart Failure
Study type: Observational
Recruitment status: Completed
Enrolment: 1,529 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Jan 2013 (actual)
Primary completion: Nov 2016 (actual)
Study completion: Sep 2017 (actual)
First posted: 6 Mar 2013 (estimated)
Results: Posted 12 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
CRT patients	–	Device: CRT PatientsPatients who have received any market approved St Jude Medical CRT-D or CRT-P device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HF patients with St. Jude Medical CRT devices

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CRT PatientsAlso: St Jude Medical, Any approved CRT deviceThis is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.	Device	CRT patients

Primary outcome

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.)
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.
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
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.

Results and safety

Results posted to the registry on 12 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cardiac Resynchronization Therapy Patients	1,529	1,175

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

Time frame: 6 months. Count of participants. Unit: Participants

Measure	CRT Patients n = 1327
Site Determined CRT Response	1061
CCS Deteremined CRT Response	900

Population analysed: The analysis population included any subject who had a 6-month CRT evaluation or died due to a cardiovascular cause prior to 6 months. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	CRT Patients n = 1299
Echocardiographic Remodeling Used	431
Clinical Functional Assessment Used	847
Clinical Events Used	858

Population analysed: The analysis population included any subject with a completed 6-month CRT evaluation. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	CRT Patients n = 1299
Device LV Pacing Change	63
Device AV/VV Intervals Optimized	197
Other Device Parameters Changed	88
Medication Changed	319
Arrythmia Treatments	79
Diet Compliance	53
Medication Compliance	42
HF Education Provided	328

Primary outcome: Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months

Time frame: Between 6 and 12 months. Count of participants. Unit: Participants

Measure	Site CRT Responders n = 559	Site CRT Non-Responders n = 90
Value	93	34

Population analysed: Only subjects who had evaluable data at 6 and 12 months are included. Thus, fewer subjects than those who completed the 6-month and 12-month visits were analyzable.

Adverse events

Time frame: Data were collected and reported over the 12-month study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRT Patients	226 of 1,524 (14.8%)	403 of 1,524 (26.4%)	132 of 1,524

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34838518Varma 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.
Derived from this study: PubMed 31748196Varma 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Niraj Varma, MD study chair

The Cleveland Clinic

69 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Abbott Medical Devices at 69 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, India, China, Japan, Brazil and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01805154, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.