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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT patients | Patients who have received any market approved St Jude Medical CRT-D or CRT-P device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT Patients | Device | This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response |
| 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. | 6 months |
| 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
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HF patients with St. Jude Medical CRT devices
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| Name | Affiliation | Role |
|---|---|---|
| Niraj Varma, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Cardiovascular Group, P.C. | Birmingham | Alabama | 35205 | United States | ||
| *Heart Center Research, LLC. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34838518 | Derived | 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. | |
| 31748196 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Resynchronization Therapy Patients | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 17, 2015 |
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| 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 | St 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 Gerais | Brazil |
| Hospital Beneficiencia Portuguesa de Sao Paulo | São Paulo | Sao Pau | Brazil |
| Instituto do Coracao (InCor) - HCFMUSP | São 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 | Medellín | Antioq | Colombia |
| Care Institute of Medical Sciences | Ahmedabad | Gujarat | India |
| Holy Family Hospital and Medical Research Center | Mumbai | Mhrshtr | India |
| Ruby Hall Clinic | Pune | Mhrshtr | India |
| Delhi Heart and Lung Institute | New Delhi | National Capital Territory of Delhi | India |
| Escorts Heart Institute and Research Centre | New Delhi | National Capital Territory of Delhi | India |
| Fortis Flt. Lt. Rajan Dhall Hospital | New Delhi | National Capital Territory of Delhi | 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-ken | Japan |
| Hirosaki University Hospital | Hirosaki-shi | Aomori | Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | Japan |
| Chiba University | Chiba | Japan |
| Heart Rhythm Management | San Juan | Puerto Rico |
| Eulji university Hospital Daejeon | Daejeon | Hoseo | South Korea |
| Samsung Medical Center | Seoul | Sudogwn | South Korea |
| Yonsei University Health System | Seoul | Sudogwn | South Korea |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Of 1529 subjects enrolled, 5 were not included in baseline analyses (1 subject had incomplete informed consent and 4 did not have a device implant). Thus, only 1524 subjects were evaluable.
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| ID | Title | Description |
|---|---|---|
| BG000 | CRT Patients | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Information was provided by 1428 subjects | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| New York Heart Association (NYHA) Class | NYHA Functional Classification has 4 categories: Class I (least severe) - no limitation of physical activity Class II - slight limitation of physical activity Class III - marked limitation of physical activity Class IV (most severe) - unable to carry on any physical activity without discomfort | information was available on 1522 subjects | Count of Participants | Participants |
| ||||||||||||||||
| Type of Cardiomyopathy | Information was available on 1518 subjects | Count of Participants | Participants |
| |||||||||||||||||
| Left Ventricular Ejection Fraction % (EF) | This is % of blood ejected from the left ventricle | Information was available on 1521 subjects | Mean | Standard Deviation | Percent blood ejected |
| |||||||||||||||
| History of Atrial Fibrillation (AF) | Information was available on 1518 subjects | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response |
| 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | Between 6 and 12 months |
|
|
Data were collected and reported over the 12-month study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CRT Patients | 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). | 132 | 1,524 | 226 | 1,524 | 403 | 1,524 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute CHF | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Arrythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fib Ablation | Cardiac disorders | Systematic Assessment |
| ||
| Air Embolism | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Arrest Cardiopulmonary | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| BLEEDING(NON-HEMATOMA) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| CARDIAC TAMPONADE | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| CARDIAC/CORONARY SINUS DISSECTION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| CHEST PAIN | Cardiac disorders | Systematic Assessment |
| ||
| ER VISIT AND OBSERVATION ADMISSION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| EROSION/EXTRUSION | Infections and infestations | Systematic Assessment |
| ||
| HEMATOMA | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| HOSPITALIZATION FOR DECREASED MENTAL STATUS AND FEVER | General disorders | Systematic Assessment |
| ||
| INFECTION | Infections and infestations | Systematic Assessment |
| ||
| LEAD DISLODGEMENT OR MIGRATION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RA LEAD FRACTURE | Product Issues | Systematic Assessment |
| ||
| RV LEAD MALFUNCTION | Product Issues | Systematic Assessment |
| ||
| LV LOSS OF CAPTURE | Product Issues | Systematic Assessment |
| ||
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
| ||
| NEW OR WORSENED ANGINA | Cardiac disorders | Systematic Assessment |
| ||
| OTHER Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| OTHER Death | Cardiac disorders | Systematic Assessment |
| ||
| OTHER Gastro | Gastrointestinal disorders | Systematic Assessment |
| ||
| OTHER General | General disorders | Systematic Assessment |
| ||
| OTHER Infections | Infections and infestations | Systematic Assessment |
| ||
| Other Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PERICARDIAL EFFUSION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| PHRENIC NERVE/DIAPHRAGMATIC STIMULATION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| PNEUMOTHORAX | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SOB; EDEMA; DIURESIS; MONITORING | General disorders | Systematic Assessment |
| ||
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| PULSE GENERATOR MALFUNCTION | Product Issues | Systematic Assessment |
| ||
| SHOCK/HYPOTENSION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SYNCOPE UNKNOWN ETIOLOGY | General disorders | Systematic Assessment |
| ||
| THROMBO-EMBOLIC EVENT | General disorders | Systematic Assessment |
| ||
| TRIMALLEOLAR FRACTURE RIGHT ANKLE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| VENTRICULAR ARRHYTHMIA | Cardiac disorders | Systematic Assessment |
| ||
| WORSENING CAD | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE CORONARY SYNDROME | Cardiac disorders | Systematic Assessment |
| ||
| ARREST - CARDIOPULMONARY | Cardiac disorders | Systematic Assessment |
| ||
| ASYSTOLE | Cardiac disorders | Systematic Assessment |
| ||
| ATRIAL ARRHYTHMIA | Cardiac disorders | Systematic Assessment |
| ||
| BLEEDING(NON-HEMATOMA) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| CHEST PAIN | General disorders | Systematic Assessment |
| ||
| CLOSTRIDIUM DIAARHEA | Gastrointestinal disorders | Systematic Assessment |
| ||
| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment |
| ||
| DECOMPENSATED HF | Cardiac disorders | Systematic Assessment |
| ||
| DIZZINESS, NAUSEA, IRREGULAR HEART BEAT | General disorders | Systematic Assessment |
| ||
| ELEVATED PACING THRESHOLDS | Product Issues | Systematic Assessment |
| ||
| FATIGUE | General disorders | Systematic Assessment |
| ||
| HEART FAILURE | Cardiac disorders | Systematic Assessment |
| ||
| HEMATOMA | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| HEMOTHORAX | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| HIGH DFT'S | Product Issues | Systematic Assessment |
| ||
| INFECTION | Infections and infestations | Systematic Assessment |
| ||
| LEAD DISLODGEMENT OR MIGRATION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lead Noise | Product Issues | Systematic Assessment |
| ||
| LOSS OF CAPTURE | Product Issues | Systematic Assessment |
| ||
| LOSS OF SENSING | Product Issues | Systematic Assessment |
| ||
| LOW CARDIAC OUTPUT SYNDROME AND PULMONARY OEDEMA | Cardiac disorders | Systematic Assessment |
| ||
| LOWER EXTREMITY EDEMA | Vascular disorders | Systematic Assessment |
| ||
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
| ||
| NEW OR WORSENED ANGINA | Cardiac disorders | Systematic Assessment |
| ||
| OTHER Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| OTHER Gastro | Gastrointestinal disorders | Systematic Assessment |
| ||
| OTHER General | General disorders | Systematic Assessment |
| ||
| OTHER Implant | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| OTHER Infections | Infections and infestations | Systematic Assessment |
| ||
| Other Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| OVERSENSING | Product Issues | Systematic Assessment |
| ||
| OVERSENSING RESULTING IN THERAPY | Product Issues | Systematic Assessment |
| ||
| PACEMAKER MEDIATED TACHYCARDIA (PMT) | Product Issues | Systematic Assessment |
| ||
| PERICARDIAL EFFUSION | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| PHRENIC NERVE/DIAPHRAGMATIC STIMULATION | Product Issues | Systematic Assessment |
| ||
| PNEUMOTHORAX | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| SHOCK/HYPOTENSION | Infections and infestations | Systematic Assessment |
| ||
| SYNCOPE UNKNOWN ETIOLOGY | General disorders | Systematic Assessment |
| ||
| THERAPY FOR NON-VENTRICULAR RHYTHM | Cardiac disorders | Systematic Assessment |
| ||
| THROMBO-EMBOLIC EVENT | General disorders | Systematic Assessment |
| ||
| UNDERSENSING | Product Issues | Systematic Assessment |
| ||
| UPPER RESIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| VENTRICULAR ARRHYTHMIA | Cardiac disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn, Clinical Program Director | Abbott | 972-309-8087 | clay.cohorn@abbott.com |
| Jul 1, 2019 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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| Asian |
|
| Black or African American |
|
| Hispanic or Latino |
|
| White or Caucasian |
|
| Other |
|
|
| United States |
|
|
| India |
|
|
| NYHA Class II |
|
| NYHA Class III |
|
| NYHA Class IV |
|
| Non-Ischemic |
|
| None |
|
|
|
|