A Phase 4 interventional study of Programming (CRT-D, ICD OptiVol® and Cardiac Compass® ) in Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Phase 4, Interventional, and Treatment
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)
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 335 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HF subjects managed with standard clinical assessment and using the audible OptiVol® Fluid status monitoring alert and the device Cardiac Compass Report
Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
HF subjects managed with standard clinical assessment
Device: Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
OptiVol® Fluid status Monitoring with Cardiac Compass
Also known as: OptiVol® audible alert
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
Time frame: 14.9 ± 5.4 months
| Milestone | Access Arm | Control Arm |
|---|---|---|
| Started | 168 | 167 |
| Completed | 137 | 141 |
| Not completed | 31 | 26 |
| Withdrew: Death | 19 | 15 |
| Withdrew: Early exit | 12 | 11 |
Number of participants with a combined end point of all-cause mortality or heart failure hospitalization
| Participants | Access Arm | Control Arm |
|---|---|---|
| Number of Participants With Combined End Point of All-cause Mortality or Heart Failure Hospitalization | 48 | 33 |
Collected over mean follow up period (months): 14.9 +/- 5.4. Non-serious events are listed at a 2.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Access Arm | — | 50/168 (29.8%) | 47/168 (28%) |
| Control Arm | — | 34/167 (20.4%) | 20/167 (12%) |
| Event | Access Arm | Control Arm |
|---|---|---|
| Cardiac failureCardiac disorders | 39/168 | 23/167 |
| PneumoniaInfections and infestations | 6/168 | 4/167 |
| Lead DislodgementInjury, poisoning and procedural complications | 4/168 | 3/167 |
| AnaemiaBlood and lymphatic system disorders | 0/168 | 2/167 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/168 | 2/167 |
| Event | Access Arm | Control Arm |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 19/168 | 11/167 |
| Chest painGeneral disorders | 8/168 | 3/167 |
| Cardiac failureCardiac disorders | 7/168 | 3/167 |
| Ventricular tachycardiaCardiac disorders | 7/168 | 0/167 |
| Oedema peripheralGeneral disorders | 6/168 | 3/167 |
| Age, Continuous(years) | Access Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 64 ± 10 | 64 ± 10 | 64 ± 10 |
| Sex: Female, Male(Participants) | Access Arm | Control Arm | Total |
|---|---|---|---|
| Female | 22 | 25 | 47 |
| Male | 146 | 142 | 288 |
| QRS duration(ms) | Access Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 142 ± 39 | 143 ± 36 | 142 ± 38 |
| Body Mass Index(kg/m^2) | Access Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 28 ± 5 | 27 ± 4 | 28 ± 4 |
| NYHA functional class(participants) | Access Arm | Control Arm | Total |
|---|---|---|---|
| NYHA functional class I | 6 | 5 | 11 |
| NYHA functional class II | 98 | 103 | 201 |
| NYHA functional class III | 63 | 58 | 121 |
| NYHA functional class IV | 1 | 1 | 2 |
| LVEF(%) | Access Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 25 ± 7 | 25 ± 7 | 25 ± 7 |
| Type of device implanted(Participants) | Access Arm | Control Arm | Total |
|---|---|---|---|
| CRT-D | 141 | 133 | 274 |
| ICD | 27 | 34 | 61 |
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure