Advance Cardiac Resynchronization Therapy (CRT) Registry

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01805154
• Collaborator: (none)
• Enrollment: 1,529
• Locations: 69
• Actual Duration (Months): 56
• Patients Per Site: 22.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CRT Patients

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1529 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
CRT patients Patients who have received any market approved St Jude Medical CRT-D or CRT-P device	Device: CRT Patients; This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.; Other Names: St Jude Medical, Any approved CRT device

Outcome Measures

Primary Outcome Measures

1. Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response [6 months]

   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.)

2. 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.

3. 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]

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Cardiovascular Group, P.C.	Birmingham	Alabama	United States	35205
2	*Heart Center Research, LLC.	Huntsville	Alabama	United States	35801
3	Cardiovascular Consultants Ltd	Glendale	Arizona	United States	85306
4	Cardiovascular Associates of Mesa	Mesa	Arizona	United States	85206
5	Phoenix Cardiovascular Research Group	Phoenix	Arizona	United States	85298
6	Southern Arizona VA Health Care System	Tucson	Arizona	United States	85723
7	Comprehensive Cardiovascular	Bakersfield	California	United States	93309
8	Chula Vista Cardiac Center	Chula Vista	California	United States	91910
9	Cardiac Rhythm Specialist	Northridge	California	United States	91325
10	Claudio Bonometti MD, Inc	Santa Barbara	California	United States	93101
11	The Cardiac & Vascular Institute Research Foundation, LLC	Gainesville	Florida	United States	32605
12	Cardiology Consultants - Baptist Campus	Pensacola	Florida	United States	32501
13	Tallahassee Research Institute	Tallahassee	Florida	United States	32308
14	VA Medical Center - Tampa	Tampa	Florida	United States	33612
15	Heartland Cardiovascular Center	Joliet	Illinois	United States	60451
16	Advocate Health and Hospitals Corporation	Oakbrook Terrace	Illinois	United States	60181
17	Unitypoint	Des Moines	Iowa	United States	50316
18	Heart Care Associates PSC	Madisonville	Kentucky	United States	42431
19	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
20	St. Elizabeth's Medical Center	Boston	Massachusetts	United States	02135
21	University of Michigan	Ann Arbor	Michigan	United States	48104
22	Cardiology Consultants of East Michigan	Flint	Michigan	United States	48532
23	*Thoracic Cardio Healthcare Found. (aka Sparrow Research)	Lansing	Michigan	United States	48912
24	Minneapolis Heart Institute	Minneapolis	Minnesota	United States	55407
25	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
26	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
27	Cardiology Associates of North Mississippi	Tupelo	Mississippi	United States	38801
28	St. Louis University Hospital	Saint Louis	Missouri	United States	63110
29	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
30	Lourdes Cardiology Services	Cherry Hill	New Jersey	United States	08043
31	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44094
32	Genesis HealthCare System	Zanesville	Ohio	United States	43701
33	Saint Vincent Consultants in Cardiovascular Diseases	Erie	Pennsylvania	United States	16502
34	Mountain States Medical Group Cardiology	Johnson City	Tennessee	United States	37601
35	Knoxville Cardiovascular Research Group, LLC	Knoxville	Tennessee	United States	37922
36	Texas Cardiac Arrhythmia	Austin	Texas	United States	78705
37	North Texas Heart Center	Dallas	Texas	United States	75231
38	Martha Jefferson	Charlottesville	Virginia	United States	22911
39	University of Washington Medical Center	Seattle	Washington	United States	98195
40	Cardiac Rhythm Specialists, S.C.	Milwaukee	Wisconsin	United States	53202
41	Cheyenne Cardiology Associates	Cheyenne	Wyoming	United States	82001
42	Fundacion Favaloro para la Docencia e Inv. med.	Buenos Aires	Riodepl	Argentina
43	Instituto Cardiovascular Buenos Aires (ICBA)	Buenos Aires	Riodepl	Argentina
44	Biocor Instituto	Nova Lima	Minas	Brazil
45	Hospital Beneficiencia Portuguesa de Sao Paulo	Sao Paulo	Sao Pau	Brazil
46	Instituto do Coracao (InCor) - HCFMUSP	Sao Paulo		Brazil
47	Anhui Provincial Hospital	Hefei	Anhui	China
48	Guizhou Provincial People's Hospital	Guiyang	Guizhou	China
49	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China
50	The 2nd Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	China
51	APEX Foundation	Medellin	Antioq	Colombia
52	Delhi Heart and Lung Institute	New Delhi	Delhi	India
53	Escorts Heart Institute and Research Centre	New Delhi	Delhi	India
54	Fortis Flt. Lt. Rajan Dhall Hospital	New Delhi	Delhi	India
55	Care Institute of Medical Sciences	Ahmedabad	Gujarat	India
56	Holy Family Hospital and Medical Research Center	Mumbai	Mhrshtr	India
57	Ruby Hall Clinic	Pune	Mhrshtr	India
58	Medanta - The Medicity Hospital	Gurgaon	Nct Dlh	India
59	Fortis Escorts Hospital	Amritsar	Punjab	India
60	Fortis Hospital	Mohali	Punjab	India
61	The Madras Medical Mission	Chennai	Tmlnadu	India
62	Fujita Health University School of medicine	Toyoake	Aichi	Japan
63	Hirosaki University Hospital	Hirosaki-shi	Aomori	Japan
64	Kokura Memorial Hospital	Kitakyushu	Fukuoka Prefecture	Japan
65	Chiba University	Chiba		Japan
66	Eulji university Hospital Daejeon	Daejeon	Hoseo	Korea, Republic of
67	Samsung Medical Center	Seoul	Sudogwn	Korea, Republic of
68	Yonsei University Health System	Seoul	Sudogwn	Korea, Republic of
69	Heart Rhythm Management	San Juan		Puerto Rico

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: Niraj Varma, MD, The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol and Informed Consent Form - Dec 17, 2015

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01805154
• Other Study ID Numbers: 60046199
• First Posted: Mar 6, 2013
• Last Update Posted: Aug 12, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Cardiac Resynchronization Therapy Patients
Arm/Group Description	Patients who have received any market approved St Jude Medical cardiac resynchronization therapy defibrillator (CRT-D) or cardiac resynchronization therapy pacemaker (CRT-P) device. Cardiac resynchronization therapy patients: This is a group of patients who are receiving bi-ventricular pacing therapy from cardiac resynchronization therapy device.
Period Title: Overall Study
STARTED	1529
COMPLETED	1175
NOT COMPLETED	354

Baseline Characteristics

Arm/Group Title	CRT Patients
Arm/Group Description	Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from a CRT device.
Overall Participants	1524
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.9 (11.5)
Sex: Female, Male (Count of Participants)
Female	480 31.5%
Male	1044 68.5%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	6 0.4%
Asian	327 21.5%
Black or African American	78 5.1%
Hispanic or Latino	113 7.4%
White or Caucasian	883 57.9%
Other	21 1.4%
Region of Enrollment (participants) [Number]
Colombia	27 1.8%
Argentina	9 0.6%
United States	1147 75.3%
India	205 13.5%
New York Heart Association (NYHA) Class (Count of Participants)
NYHA Class I	45 3%
NYHA Class II	335 22%
NYHA Class III	1033 67.8%
NYHA Class IV	109 7.2%
Type of Cardiomyopathy (Count of Participants)
Ischemic	597 39.2%
Non-Ischemic	709 46.5%
None	212 13.9%
Left Ventricular Ejection Fraction % (EF) (Percent blood ejected) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent blood ejected]	29.2 (11.2)
History of Atrial Fibrillation (AF) (Count of Participants)
Count of Participants [Participants]	583 38.3%

Outcome Measures

1. Primary Outcome

Title	Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response
Description	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.)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CRT Patients
Arm/Group Description	Patients who received any market approved St. Jude Medical CRT-D or CRT-P device.
Measure Participants	1327
Site Determined CRT Response	1061 69.6%
CCS Deteremined CRT Response	900 59.1%

2. Primary Outcome

Title	Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT
Description	Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CRT Patients
Arm/Group Description	Patients who received any market approved St. Jude Medical CRT-D or CRT-P device.
Measure Participants	1299
Echocardiographic Remodeling Used	431 28.3%
Clinical Functional Assessment Used	847 55.6%
Clinical Events Used	858 56.3%

3. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CRT Patients
Arm/Group Description	Patients who have received any market approved St. Jude Medical CRT-D or CRT-P device
Measure Participants	1299
Device LV Pacing Change	63 4.1%
Device AV/VV Intervals Optimized	197 12.9%
Other Device Parameters Changed	88 5.8%
Medication Changed	319 20.9%
Arrythmia Treatments	79 5.2%
Diet Compliance	53 3.5%
Medication Compliance	42 2.8%
HF Education Provided	328 21.5%
Other Treatments	71 4.7%
Treatment for Comorbidities	100 6.6%
Bi-Ventricular Pacing Increase	43 2.8%

4. Primary Outcome

Title	Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months
Description	Improvement in NYHA Class determined by improvement by at least 1 class.
Time Frame	Between 6 and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Site CRT Responders	Site CRT Non-Responders
Arm/Group Description	Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT responders at 6 months.	Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device and were classified as CRT non-responders at 6 months.
Measure Participants	559	90
Count of Participants [Participants]	93 6.1%	34 NaN

Adverse Events

Time Frame	Data were collected and reported over the 12-month study period.
Arm/Group Title	CRT Patients
Arm/Group Description	Patients who have received any market approved St Jude Medical CRT-D or CRT-P device CRT Patients: This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device. Of 1529 subjects enrolled, 5 were not included in analysis (1 had incomplete informed consent and 4 did not receive a device implant).
All Cause Mortality
	CRT Patients
	Affected / at Risk (%)	# Events
Total	132/1524 (8.7%)
Serious Adverse Events
	CRT Patients
	Affected / at Risk (%)	# Events
Total	226/1524 (14.8%)
Cardiac disorders
Acute CHF	70/1524 (4.6%)	102
Atrial Arrythmia	12/1524 (0.8%)	14
Atrial Fib Ablation	3/1524 (0.2%)	3
CHEST PAIN	1/1524 (0.1%)	1
MYOCARDIAL INFARCTION	19/1524 (1.2%)	20
NEW OR WORSENED ANGINA	4/1524 (0.3%)	4
OTHER Cardiac	8/1524 (0.5%)	10
OTHER Death	5/1524 (0.3%)	5
VENTRICULAR ARRHYTHMIA	11/1524 (0.7%)	11
WORSENING CAD	1/1524 (0.1%)	1
Gastrointestinal disorders
OTHER Gastro	6/1524 (0.4%)	6
General disorders
HOSPITALIZATION FOR DECREASED MENTAL STATUS AND FEVER	1/1524 (0.1%)	1
OTHER General	37/1524 (2.4%)	43
SOB; EDEMA; DIURESIS; MONITORING	1/1524 (0.1%)	1
SYNCOPE UNKNOWN ETIOLOGY	2/1524 (0.1%)	2
THROMBO-EMBOLIC EVENT	2/1524 (0.1%)	2
Infections and infestations
EROSION/EXTRUSION	3/1524 (0.2%)	3
INFECTION	7/1524 (0.5%)	7
OTHER Infections	14/1524 (0.9%)	17
Injury, poisoning and procedural complications
Air Embolism	1/1524 (0.1%)	1
Arrest Cardiopulmonary	4/1524 (0.3%)	4
BLEEDING(NON-HEMATOMA)	7/1524 (0.5%)	7
CARDIAC TAMPONADE	2/1524 (0.1%)	2
CARDIAC/CORONARY SINUS DISSECTION	1/1524 (0.1%)	1
ER VISIT AND OBSERVATION ADMISSION	1/1524 (0.1%)	1
HEMATOMA	6/1524 (0.4%)	7
LEAD DISLODGEMENT OR MIGRATION	41/1524 (2.7%)	51
PERICARDIAL EFFUSION	2/1524 (0.1%)	2
PHRENIC NERVE/DIAPHRAGMATIC STIMULATION	2/1524 (0.1%)	2
PNEUMOTHORAX	3/1524 (0.2%)	3
SHOCK/HYPOTENSION	5/1524 (0.3%)	6
Musculoskeletal and connective tissue disorders
TRIMALLEOLAR FRACTURE RIGHT ANKLE	1/1524 (0.1%)	1
Product Issues
RA LEAD FRACTURE	1/1524 (0.1%)	1
RV LEAD MALFUNCTION	1/1524 (0.1%)	1
LV LOSS OF CAPTURE	2/1524 (0.1%)	3
PULSE GENERATOR MALFUNCTION	1/1524 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Other Respiratory	7/1524 (0.5%)	11
PULMONARY EMBOLISM	1/1524 (0.1%)	1
Other (Not Including Serious) Adverse Events
	CRT Patients
	Affected / at Risk (%)	# Events
Total	403/1524 (26.4%)
Cardiac disorders
ACUTE CORONARY SYNDROME	1/1524 (0.1%)	1
ARREST - CARDIOPULMONARY	2/1524 (0.1%)	2
ASYSTOLE	1/1524 (0.1%)	1
ATRIAL ARRHYTHMIA	37/1524 (2.4%)	39
DECOMPENSATED HF	98/1524 (6.4%)	133
HEART FAILURE	1/1524 (0.1%)	1
LOW CARDIAC OUTPUT SYNDROME AND PULMONARY OEDEMA	1/1524 (0.1%)	1
MYOCARDIAL INFARCTION	1/1524 (0.1%)	1
NEW OR WORSENED ANGINA	7/1524 (0.5%)	7
OTHER Cardiac	18/1524 (1.2%)	20
THERAPY FOR NON-VENTRICULAR RHYTHM	9/1524 (0.6%)	13
VENTRICULAR ARRHYTHMIA	7/1524 (0.5%)	51
Gastrointestinal disorders
CLOSTRIDIUM DIAARHEA	1/1524 (0.1%)	1
CONSTIPATION	1/1524 (0.1%)	1
OTHER Gastro	26/1524 (1.7%)	26
General disorders
CHEST PAIN	1/1524 (0.1%)	1
DIZZINESS, NAUSEA, IRREGULAR HEART BEAT	1/1524 (0.1%)	1
FATIGUE	1/1524 (0.1%)	1
OTHER General	174/1524 (11.4%)	284
SYNCOPE UNKNOWN ETIOLOGY	7/1524 (0.5%)	7
THROMBO-EMBOLIC EVENT	6/1524 (0.4%)	6
Infections and infestations
INFECTION	25/1524 (1.6%)	26
OTHER Infections	37/1524 (2.4%)	53
SHOCK/HYPOTENSION	5/1524 (0.3%)	5
UPPER RESIRATORY TRACT INFECTION	1/1524 (0.1%)	1
Injury, poisoning and procedural complications
BLEEDING(NON-HEMATOMA)	7/1524 (0.5%)	7
HEMATOMA	17/1524 (1.1%)	18
HEMOTHORAX	1/1524 (0.1%)	1
LEAD DISLODGEMENT OR MIGRATION	5/1524 (0.3%)	5
OTHER Implant	12/1524 (0.8%)	12
PERICARDIAL EFFUSION	2/1524 (0.1%)	2
PNEUMOTHORAX	1/1524 (0.1%)	1
Product Issues
ELEVATED PACING THRESHOLDS	14/1524 (0.9%)	14
HIGH DFT'S	1/1524 (0.1%)	1
Lead Noise	3/1524 (0.2%)	3
LOSS OF CAPTURE	6/1524 (0.4%)	7
LOSS OF SENSING	2/1524 (0.1%)	2
OVERSENSING	9/1524 (0.6%)	10
OVERSENSING RESULTING IN THERAPY	1/1524 (0.1%)	1
PACEMAKER MEDIATED TACHYCARDIA (PMT)	5/1524 (0.3%)	5
PHRENIC NERVE/DIAPHRAGMATIC STIMULATION	33/1524 (2.2%)	38
UNDERSENSING	2/1524 (0.1%)	2
Respiratory, thoracic and mediastinal disorders
Other Respiratory	18/1524 (1.2%)	23
Vascular disorders
LOWER EXTREMITY EDEMA	1/1524 (0.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.