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Low enrollment rates
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The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.
The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol® Alert and/or SentryCheck™ Monitor/PatientLook™ Indicator and evaluation using OptiVol® Fluid Status Monitoring with Cardiac Compass. OptiVol® Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products (CRT, CRT-D and ICD devices)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Access Arm | Experimental | HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report |
|
| Control arm | Active Comparator | HF subjects managed with standard clinical assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) | Device | OptiVol® Fluid status Monitoring with Cardiac Compass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization | Number of participants with a combined end point of all-cause mortality or heart failure hospitalization | 14.9 ± 5.4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. D.J. van Veldhuisen, MD | Groningen University Hospital, The Netherlands | Study Chair |
| Prof. Dr. med. M. Borggrefe | Ruprecht-Karls-Universität Heidelberg, Germany | Study Chair |
| Prof. Dr. V. Conraads | Universitair Ziekenhuis Brussel | Principal Investigator |
| Prof. C.M. Yu | Prince of Wales Hospital, Shatin, Hong Kong | Principal Investigator |
| Dr. F. Braunschweig | Karolinska University Hospital | Principal Investigator |
| Prof. Dr. J. Kautzner | IKEM- Klinika Kardiologie, Czech Republic | Principal Investigator |
| Prof. Dr. G. Jondeau | Hôpital Bichat Claude Bernard, France | Principal Investigator |
| Prof. Dr. M.R. Cowie | National Heart & Lung Institute, United Kingdom | Principal Investigator |
| Dr. R. Muñoz-Aguilera | Hospital General Universitario Gregorio Marañon, Spain |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic Bakken Research Center | Maastricht | 6229 GW | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21931078 | Result | van Veldhuisen DJ, Braunschweig F, Conraads V, Ford I, Cowie MR, Jondeau G, Kautzner J, Aguilera RM, Lunati M, Yu CM, Gerritse B, Borggrefe M; DOT-HF Investigators. Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation. 2011 Oct 18;124(16):1719-26. doi: 10.1161/CIRCULATIONAHA.111.043042. Epub 2011 Sep 19. | |
| 24519908 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Access Arm | HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass |
| FG001 | Control Arm | HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) : OptiVol® Fluid status Monitoring with Cardiac Compass |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Access Arm | HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | patient age and SD is similar between the 2 arms |
| 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 Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization | Number of participants with a combined end point of all-cause mortality or heart failure hospitalization | Posted | Count of Participants | Participants | 14.9 ± 5.4 months |
|
mean follow up period (months): 14.9 +/- 5.4
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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 | Access Arm | HF subjects managed with standard clinical assessment and using OptiVol® Fluid status monitoring with Cardiac Compass Report Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director CRDM | Medtronic Bakken Research Center | 31-43-3566813 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Intervention: in the access arm the patiens had programmmed the audible OptiVol Fliud status alert "on". Control patienst had programmed the audible alert "off"
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| Prof. I. Ford | Robertson Center for Biostatistics, Scotland | Principal Investigator |
| Dr. M Lunati | Azienda Ospedaliera Niguarda Ca' Granda | Principal Investigator |
| Conraads VM, Spruit MA, Braunschweig F, Cowie MR, Tavazzi L, Borggrefe M, Hill MR, Jacobs S, Gerritse B, van Veldhuisen DJ. Physical activity measured with implanted devices predicts patient outcome in chronic heart failure. Circ Heart Fail. 2014 Mar 1;7(2):279-87. doi: 10.1161/CIRCHEARTFAILURE.113.000883. Epub 2014 Feb 11. |
HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| QRS duration | Mean | Standard Deviation | ms |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| NYHA functional 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. | Number | participants |
|
| LVEF | Mean | Standard Deviation | % |
|
| Type of device implanted | Count of Participants | Participants |
|
|
|
|
| 50 |
| 168 |
| 47 |
| 168 |
| EG001 | Control Arm | HF subjects managed with standard clinical assessment Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ): OptiVol® Fluid status Monitoring with Cardiac Compass | 34 | 167 | 20 | 167 |
| Cardiac failure | Cardiac disorders |
|
| Pneumonia | Infections and infestations |
|
| Lead Dislodgement | Injury, poisoning and procedural complications |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Ventricular tachycardia | Cardiac disorders |
|
| Chest pain | General disorders |
|
| Oedema peripheral | General disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
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