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The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation.
The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle.
Cardiac resynchronization therapy (CRT) reduces mortality and the risk of heart failure decompensation and improves quality of life in indicated patients. However, many do not benefit due to failure to deliver the left ventricular (LV) lead via coronary sinus (5-10%) or lack of symptomatic improvement (30-40%).
The purpose of the ALSYNC Study was to evaluate the feasibility and safety of LV endocardial (LVE) pacing using a Model 3830 lead implanted by a novel pectoral atrial transseptal lead delivery system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocardial Left Ventricular pacing | Experimental | All patients will undergo the intervention, and are followed at 1, 3, 6, and 12 months (minimum) and biannually thereafter until 1 year after enrollment of the last patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocardial Left Ventricular pacing | Device | Subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter, using trans esophageal echo (TEE) or intra-cardiac echo (ICE) to guide the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. | Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Success | Number of participants with a successful implant of Model 3830 lead. | Implant |
| Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor | Questionaires were collected for each LV lead implant attempt, reattempt, and LV lead modification. To evaluate the ease of positioning of the Model 3830 lead and the Models 6227ATS and 6248HS, JS, JL catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent was used for each of the ten questions on the questionnaire. Outcome reports the number of questionnaires where no single question was answered with Poor. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor John Morgan, MD | Spire Southampton Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan - Campus Sint-Jan | Bruges | Belgium | ||||
| Centre Hospitalier Regional de la Citadelle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29579617 | Derived | Biffi M, Defaye P, Jais P, Ruffa F, Leclercq C, Gras D, Yang Z, Gerritse B, Ziacchi M, Morgan JM; ALSYNC Investigators. Benefits of left ventricular endocardial pacing comparing failed implants and prior non-responders to conventional cardiac resynchronization therapy: A subanalysis from the ALSYNC study. Int J Cardiol. 2018 May 15;259:88-93. doi: 10.1016/j.ijcard.2018.01.030. | |
| 26787437 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LV Endocardial Lead | subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Implant |
| Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months | Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit. | 12 months |
| Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months | Bipolar measurement of Model 3830 lead voltage threshold at 0.4ms pulse width using the implanted device at the 12 month visit | 12 months |
| Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months | Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit | 12 months |
| Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months | NYHA Class change was evaluated between baseline and the 6 months visit. Reported are the subjects with at least 1 class improvement from baseline to 6 months | baseline and 6 months |
| Distance Walked at 6 Minute Hall Walk at the 12 Month Visit | Distance walked at the 6 minute hall walk test at the 12 month visit | 12 months |
| Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months | Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months | baseline and 6 months |
| Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months | Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months | 6 months |
| Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months | Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months | baseline and 6 months |
| Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months | Reported is the number of patients with at least one class improvement from baseline to 6 months | baseline and 6 months |
| Change in (NT-pro)BNP Levels From Baseline to 6 Months | Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months | baseline and 6 months |
| Liège |
| Belgium |
| Saint Paul's Hospital | Vancouver | British Columbia | Canada |
| London Health Sciences Centre - University Campus | London | Ontario | Canada |
| Hôpital Haut-Lévêque - CHU de Bordeaux | Bordeaux | France |
| CHU Grenoble Hôpital Michalon | Grenoble | France |
| Infirmerie Protestante de Lyon | Lyon | France |
| Nouvelles Cliniques Nantaises | Nantes | France |
| Hôpital Pontchaillou - CHU de Rennes | Rennes | France |
| Semmelweis Egyetem AOK | Budapest | Hungary |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi | Bologna | Italy |
| Presidio Ospedaliero Alessandro Manzoni | Lecco | Italy |
| Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri | Roma | Italy |
| Academisch Ziekenhuis Maastricht (AZM) | Maastricht | Netherlands |
| Royal Victoria Hospital | Belfast | United Kingdom |
| Golden Jubilee National Hospital | Glasgow | United Kingdom |
| University College London Hospitals NHS Foundation Trust - The Heart Hospital | London | United Kingdom |
| Southampton General Hospital | Southhampton | United Kingdom |
| Derived |
| Morgan JM, Biffi M, Geller L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18. |
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled subjects meeting eligibility criteria are included in the baseline analysis population. 2 subjects were not included from the overall number of subjects that completed the study because they had a major eligibility violation (both had left superior vena cava).
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| ID | Title | Description |
|---|---|---|
| BG000 | Left Ventricular Endocardial Pacing | All enrolled patients were scheduled to receive a CRT implantation with endocardial LV lead |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| New York Heart Association (NYHA) Class | Classification of symptoms: Class I=No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea. Class II=Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. Class III=Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV=Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Count of Participants | Participants |
| |||||||||||||||||
| Atrial Fibrillation | Number of subjects that have Atrial Fibrillation at baseline | Count of Participants | Participants |
| |||||||||||||||||
| Left Bundle Branch Block (LBBB) | Number of subjects that have LBBB at baseline | Count of Participants | Participants |
| |||||||||||||||||
| QRS duration | The duration in milliseconds (ms) of the QRS complex in the subject's electrocardiogram at baseline. | Mean | Standard Deviation | milliseconds (ms) |
| ||||||||||||||||
| Left Ventricular Ejection Fraction (LVEF) | The percentage of blood leaving the heart each time it contracts | Mean | Standard Deviation | percentage |
|
| 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 | Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. | Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval. | The Analysis cohort (132) includes the Baseline cohort (136) (Enrolled patients (138), excluding patients exited for eligibility violation without implant attempt and patients removed for major eligibility violation (2)), excluding patients that did not have implant attempt (4). | Posted | Number | 95% Confidence Interval | percentage of patients | 6 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Implant Success | Number of participants with a successful implant of Model 3830 lead. | The Analysis cohort (132) includes the Baseline cohort (136) (Enrolled patients (138), excluding patients exited for eligibility violation without implant attempt and patients removed for major eligibility violation (2)), excluding patients that did not have implant attempt (4). | Posted | Count of Participants | Participants | Implant |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor | Questionaires were collected for each LV lead implant attempt, reattempt, and LV lead modification. To evaluate the ease of positioning of the Model 3830 lead and the Models 6227ATS and 6248HS, JS, JL catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent was used for each of the ten questions on the questionnaire. Outcome reports the number of questionnaires where no single question was answered with Poor. | Participants analyzed are those in the Analysis cohort as described before (132). The unit of analysis is a questionnaire for each attempted Model 3820 lead implant (139). In 7 cases their was a repeat procedure (reported as repeat implant attempt or system modification). | Posted | Count of Units | questionnaire | Implant | questionnaire | questionnaire |
|
| |||||||||||||||||||||||||
| Secondary | Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months | Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit. | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 5 had a missing R-wave amplitude measurement | Posted | Mean | Standard Deviation | Bipolar Sensing Amplitude in milliVolts | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months | Bipolar measurement of Model 3830 lead voltage threshold at 0.4ms pulse width using the implanted device at the 12 month visit | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 4 had a missing bipolar pacing threshold measurement | Posted | Mean | Standard Deviation | Bipolar LV pacing threshold in Volts | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months | Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit and 3 had a missing impedance measurement | Posted | Mean | Standard Deviation | Bipolar LV Pacing Impedance in Ohms | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months | NYHA Class change was evaluated between baseline and the 6 months visit. Reported are the subjects with at least 1 class improvement from baseline to 6 months | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 13 patients had a missing 6-months follow-up visit. | Posted | Count of Participants | Participants | baseline and 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Distance Walked at 6 Minute Hall Walk at the 12 Month Visit | Distance walked at the 6 minute hall walk test at the 12 month visit | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 24 patients had a missing 12-months follow-up visit, and 18 did not complete the test. | Posted | Mean | Standard Deviation | Distance walked in meters | 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months | Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 18 patients had a missing LVEF measurement at baseline and/or 6 months. | Posted | Mean | Standard Deviation | Percent change in LVEF | baseline and 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months | Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 27 patients had a missing LVESV measurement at baseline and/or 6 months. | Posted | Mean | Standard Deviation | LVESV change in milliliters | 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months | Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 17 patients had a missing LVEDD measurement at baseline and/or 6 months. | Posted | Mean | Standard Deviation | millimeters change in LVEDD | baseline and 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months | Reported is the number of patients with at least one class improvement from baseline to 6 months | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 16 patients had a missing MR measurement at baseline and/or 6 months. | Posted | Count of Participants | Participants | baseline and 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change in (NT-pro)BNP Levels From Baseline to 6 Months | Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months | Of the 118 patients that were successfully implanted with the Model 3830 lead in the LV, 22 patients had a missing (NTpro)BNP measurement at baseline and/or 6 months. | Posted | Mean | Standard Deviation | change in picograms per milliliter | baseline and 6 months |
|
|
Serious adverse events are reported with onset between the start of the LV endocardial implant procedure and the end of follow-up, which was after 17.3 months on average.
Serious adverse events are reported for the 132 patients that had an attempt to implant an endocardial LV lead. Implantation was successful for 118 patients.
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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 | Left Ventricular Endocardial Pacing | subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter and guidance of TEE or ICE. Medtronic Model 6227ATS deflectable delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter: Endocardial Left Ventricular pacing lead delivery Medtronic Model 3830: Endocardial Left Ventricular pacing | 23 | 132 | 86 | 132 | 49 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Electromechanical dissociation | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Retinal artery thrombosis | Eye disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac failure | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Presyncope | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac vein perforation | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Device dislocation | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Device lead damage | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Device migration | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site reaction | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Lead dislodgement | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| International normalised ratio decreased | Investigations | MedDRA v12.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v12.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v12.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v12.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v12.1 | Systematic Assessment |
| |
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v12.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Device psychogenic complication | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Bronchopulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac failure | Surgical and medical procedures | MedDRA v12.1 | Systematic Assessment |
| |
| Extrusion of device | Surgical and medical procedures | MedDRA v12.1 | Systematic Assessment |
| |
| Peripheral revascularisation | Surgical and medical procedures | MedDRA v12.1 | Systematic Assessment |
| |
| Arterial disorder | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site haematoma | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Metamorphopsia | Eye disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Oesophageal disorder | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site fibrosis | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Inappropriate device stimulation of tissue | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Inappropriate device therapy | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
| |
| Lead dislodgement | Injury, poisoning and procedural complications | MedDRA v12.1 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA v12.1 | Systematic Assessment |
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| Troponin | Investigations | MedDRA v12.1 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v12.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v12.1 | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Migraine with aura | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Transient acantholytic dermatosis | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Implant site haematoma | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v12.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mireille van Ginneken, Principal Clinical Research Specialist | Medtronic Bakken Research Center B.V. | +31433566801 | mireille.vanginneken@medronic.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| NYHA Class III |
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| NYHA Class IV |
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