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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Medtronic Japan Co., Ltd. | INDUSTRY |
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The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.
The purpose of the Mid-Q Response study is to test the hypothesis that the AdaptivCRT (aCRT) algorithm is superior to standard CRT therapy regarding patient outcomes in CRT indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction and left bundle branch block (LBBB).
The study will be executed at approximately 60 centers in Asia. The subjects will be randomly assigned in a 1:1 ratio to the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Nonadaptive CRT) group.
The primary objective is to test the hypothesis that aCRT ON increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF at 6 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdaptivCRT ON (aCRT ON, treatment group) | Experimental | AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise. |
|
| AdaptivCRT OFF (aCRT OFF, control group) | Active Comparator | AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aCRT ON | Device | CRT device with AdaptivCRT enabled |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Composite Score | The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post-randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened New York Heart Association (NYHA) class (using last observation carried forward), or worsened status on the Global Assessment Score. Also, patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged including all patients that miss NYHA class and Global Assessment Score data and are not classified Worsened because of death, HF hospitalization, exit or crossover. | 6 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in New York Heart Association (NYHA) Class | NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazutaka Aonuma, MD | University of Tsukuba Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gleneagles Jerudong Park Medical Centre | Bandar Seri Begawan | Brunei | ||||
| Ruijin Hospital Shanghai Jiao Tong University School of Medicine |
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Patients were enrolled as long as they met the inclusion criteria and were willing to consent. A total of 177 subjects were enrolled, of which 171 subjects were randomized between Adaptive and Conventional CRT.
The study was multicentric and in a hospital setting, patients selected were heart failure patients in Asian countries indicated for CRT per local guidelines with moderately wide QRS (duration ≥120ms and <150ms), preserved AV conduction (PR interval ≤ 200 ms), along with a Left bundle branch block (LBBB).
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| ID | Title | Description |
|---|---|---|
| FG000 | AdaptivCRT ON (aCRT ON, Treatment Group) | AdaptivCRT programmed to "Adaptive Bi-V and LV". The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise. aCRT ON: CRT device with AdaptivCRT enabled |
| FG001 | AdaptivCRT OFF (aCRT OFF, Control Group) |
| 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 | Yes | No | No | Study Protocol | Dec 29, 2020 | Apr 10, 2025 |
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Eligible subjects will be randomized after baseline assessment and implant of a CRT system containing the aCRT algorithm. Randomization will be done in a 1:1 ratio to either treatment (aCRT ON, Adaptive Bi-V and LV) or control (aCRT OFF, Nonadaptive CRT) groups. All subjects, independent of randomization assignment, will have a CRT system.
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| aCRT OFF |
| Device |
CRT device with AdaptivCRT disabled |
|
| Baseline to 6 and 12 months post-randomization |
| Occurrence of Hospitalizations for Worsening Heart Failure | Defined as an event requiring inpatient hospitalization or invasive intervention | 12 months post-randomization |
| All-cause Mortality | All-cause mortality in the aCRT ON group vs the aCRT OFF group | 12 months post-randomization |
| Cardiovascular-related Mortality | Defined as all cardiac deaths as well as any cardiovascular deaths that are not directly a result of mechanical or electrical heart dysfunction. | 12 months post-randomization |
| Shanghai |
| China |
| Grantham Hospital | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital | Hong Kong | Hong Kong |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| National Cardiovascular Center Harapan Kita | Jakarta | 11420 | Indonesia |
| University of Fukui Hospital | Fukui | Japan |
| Kokura Memorial Hospital | Fukuoka | Japan |
| Hirosaki University Hospital | Hirosaki | Japan |
| Hiroshima Prefectural Hospital | Hiroshima | Japan |
| The Hospital of Hyogo College of Medicine | Hyōgo | Japan |
| University of Tsukuba Hospital | Ibaraki | Japan |
| Tokai University Hospital | Isehara | Japan |
| Kitasato University Hospital | Kanagawa | Japan |
| St. Marianna University School of Medicine Hospital | Kawasaki | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Japan |
| Kurashiki Central Hospital | Kurashiki | Japan |
| Tohoku University Hospital | Miyagi | Japan |
| Miyazaki Medical Association Hospital | Miyazaki | Japan |
| University of Miyazaki Hospital | Miyazaki | Japan |
| Iwate Medical University Hospital | Morioka | Japan |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Nagoya | Japan |
| Nagoya University Hospital | Nagoya | Japan |
| Okayama University Hospital | Okayama | Japan |
| The Sakakibara Heart Institute of Okayama | Okayama | Japan |
| National Cerebral and Cardiovascular Center | Osaka | Japan |
| Sakurabashi Watanabe Hospital | Osaka | Japan |
| Japanese Red Cross Saitama Hospital | Saitama | Japan |
| Saitama Medical Center Jichi Medical University | Saitama | Japan |
| Saitama Medical University International Medical Center | Saitama | Japan |
| Shizuoka General Hospital | Shizuoka | Japan |
| Juntendo University Hospital | Tokyo | Japan |
| Kyorin University Hospital | Tokyo | Japan |
| Fujita Health University Hospital | Toyoake | Japan |
| Yamagata Prefectural Central Hospital | Yamagata | Japan |
| Saiseikai Yokohama tobu Hospital | Yokohama | Japan |
| St. Marianna University Yokohama City Seibu Hospital | Yokohama | Japan |
| Oita University Hospital | Yufu | Japan |
| Hospital Sultanah Bahiyah | Alor Star | Malaysia |
| Hospital Serdang | Kajang | Malaysia |
| Sarawak Heart Center | Kota | Malaysia |
| Institut Jantung Negara - National Heart Institute | Kuala Lumpur | Malaysia |
| Sarawak Heart Centre | Kuching | Malaysia |
| Makati Medical Center | Makati | Philippines |
| Changi General Hospital | Singapore | Singapore |
| National University Hospital | Singapore | Singapore |
| Tan Tock Seng Hospital | Singapore | Singapore |
| Sejong General Hospital | Bucheon-si | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Kyung Hee University Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| National Taiwan University Hospital Hsin Chu Branch | Hsinchu | Taiwan |
| Kaohsing Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Chang Gung Memorial Hospital Linkou | Taoyuan City | 333 | Taiwan |
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. aCRT OFF: CRT device with AdaptivCRT disabled |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Number of subjects randomized following successful implant
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| ID | Title | Description |
|---|---|---|
| BG000 | AdaptivCRT ON (aCRT ON, Treatment Group) | AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise. aCRT ON: CRT device with AdaptivCRT enabled |
| BG001 | AdaptivCRT OFF (aCRT OFF, Control Group) | AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected. aCRT OFF: CRT device with AdaptivCRT disabled |
| BG002 | Total | Total of all reporting groups |
| 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| NYHA class | Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Count of Participants | Participants |
| |||||||||||||||
| LVEF | Left ventricular ejection fraction | Mean | Standard Deviation | percent |
| ||||||||||||||
| QRS duration | Mean | Standard Deviation | ms |
| |||||||||||||||
| PR interval | Mean | Standard Deviation | ms |
|
| 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 | Clinical Composite Score | The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post-randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened New York Heart Association (NYHA) class (using last observation carried forward), or worsened status on the Global Assessment Score. Also, patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged including all patients that miss NYHA class and Global Assessment Score data and are not classified Worsened because of death, HF hospitalization, exit or crossover. | All randomized subjects | Posted | Count of Participants | Participants | 6 months post-randomization |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in New York Heart Association (NYHA) Class | NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | All randomized subjects | Posted | Count of Participants | Participants | Baseline to 6 and 12 months post-randomization |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Hospitalizations for Worsening Heart Failure | Defined as an event requiring inpatient hospitalization or invasive intervention | All randomized subjects | Posted | Count of Participants | Participants | 12 months post-randomization |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality | All-cause mortality in the aCRT ON group vs the aCRT OFF group | All randomized subjects | Posted | Count of Participants | Participants | 12 months post-randomization |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cardiovascular-related Mortality | Defined as all cardiac deaths as well as any cardiovascular deaths that are not directly a result of mechanical or electrical heart dysfunction. | All randomized subjects | Posted | Count of Participants | Participants | 12 months post-randomization |
|
|
The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
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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 | AdaptivCRT ON (aCRT ON, Treatment Group) | AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise. aCRT ON: CRT device with AdaptivCRT enabled | 5 | 86 | 27 | 86 | 8 | 86 |
| EG001 | AdaptivCRT OFF (aCRT OFF, Control Group) | AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected. aCRT OFF: CRT device with AdaptivCRT disabled | 6 | 85 | 24 | 85 | 14 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myocardial injury | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Medical device site inflammation | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Congestive hepatopathy | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Emphysematous pyelonephritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pleural infection bacterial | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Post procedural cellulitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Post stroke epilepsy | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lead dislodgement | Product Issues | MedDRA (26.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Urethral perforation | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Medical device site pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Device stimulation issue | Product Issues | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lidwien Vainer | Medtronic, Bakken Research Center B.V. | +31610419653 | lidwien.vainer@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2019 | Apr 10, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
|
|
|
|
| Worsened |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| Class III/IV |
|
| Not reported |
|
| Class III/IV |
|
| Not reported |
|
| Class III/IV |
|
| Not reported |
|