Congestive Heart Failure Treated
Conditions
Keywords
Heart Failure, Cardiac Resynchronization Therapy, Remote Care, Disease Management
Brief summary
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT-D) device reprogramming.
Detailed description
The outcome measure of the study is a combined endpoint of: * Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months * Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management
Interventions
DEVICERemote Care Follow up
Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1 * 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months * Left Bundle Branch Block (LBBB) * Patients must be able to provide written informed consent * Patients are mentally capable to participate in the Investigation (based on physician's discretion)
Exclusion criteria
* Patients already implanted with CRT or CRT-D device to be replaced * Patients in long-standing persistent or permanent AT/AF * Patients in dialysis treatment at the time of enrollment * Patients in parenteral inotropic therapy at the time of enrollment * Patients with epicardial Left Ventricular (LV) lead * Patients with mechanical valvular prosthesis * Patients with life expectancy \< 12 months * Patients actively considered for cardiac transplant * Patients \< 18 years old * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Endpoint on Patient Clinical Outcome | 12 months follow up | Combined Endpoint: * proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months * proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months |
Countries
Italy
Participant flow
Recruitment details
5 subjects not randomized. 139 Subjects randomized in 2 arms
Participants by arm
| Arm | Count |
|---|---|
| Optimal Remote Care Patient follow up is performed through remote care, remote alerts on Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.
Remote Care Follow up: Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed | 66 |
| Optimal Standard Care Patient standard in clinic visits are performed every 6 months. | 73 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 10 |
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Physician Decision | 0 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Optimal Remote Care | Optimal Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 11.3 | 71.9 years STANDARD_DEVIATION 10.6 | 71.0 years STANDARD_DEVIATION 10.9 |
| Comorbidities Chronic Obstructive Pulmonary Disease | 8 Participants | 13 Participants | 21 Participants |
| Comorbidities Chronic Renal Insufficiency | 8 Participants | 9 Participants | 17 Participants |
| Comorbidities Diabetes Mellitus | 14 Participants | 19 Participants | 33 Participants |
| Comorbidities Dysthyroidism | 5 Participants | 5 Participants | 10 Participants |
| Comorbidities Hypercholesterolemia | 26 Participants | 16 Participants | 42 Participants |
| Comorbidities Hypertension | 38 Participants | 38 Participants | 76 Participants |
| Comorbidities None | 2 Participants | 7 Participants | 9 Participants |
| Comorbidities Other | 14 Participants | 24 Participants | 38 Participants |
| Comorbidities Paroxysmal AT/AF | 6 Participants | 10 Participants | 16 Participants |
| Comorbidities Smoking | 32 Participants | 29 Participants | 61 Participants |
| Current Medication Aldosterone Antagonist | 23 Participants | 24 Participants | 47 Participants |
| Current Medication Amiodarone | 12 Participants | 15 Participants | 27 Participants |
| Current Medication Angiotensin-Converting Enzyme (ACE) Inhibitors | 40 Participants | 49 Participants | 89 Participants |
| Current Medication Angiotensin Receptor Blockers (ARBs) | 13 Participants | 16 Participants | 29 Participants |
| Current Medication Beta Blockers | 53 Participants | 60 Participants | 113 Participants |
| Current Medication Cardiac Glycosides | 6 Participants | 3 Participants | 9 Participants |
| Current Medication Diuretics | 63 Participants | 66 Participants | 129 Participants |
| Current Medication Other | 57 Participants | 64 Participants | 121 Participants |
| Current Medication Other Antiarrhythmics | 1 Participants | 3 Participants | 4 Participants |
| Current Medication Statins | 35 Participants | 32 Participants | 67 Participants |
| Etiology of cardiovascular disease (Ischemic/Non Ischemic) Ischemic | 31 Participants | 27 Participants | 58 Participants |
| Etiology of cardiovascular disease (Ischemic/Non Ischemic) Non Ischemic | 35 Participants | 44 Participants | 79 Participants |
| Height (cm) | 169.0 cm STANDARD_DEVIATION 7.8 | 168.5 cm STANDARD_DEVIATION 8 | 168.7 cm STANDARD_DEVIATION 7.9 |
| Implant Information Final Programmed LV Configuration (Distal 1 - Mid 2) | 26 Participants | 29 Participants | 55 Participants |
| Implant Information Final Programmed LV Configuration (Distal 1 - Prox 4) | 2 Participants | 5 Participants | 7 Participants |
| Implant Information Final Programmed LV Configuration (Distal 1 - RV Coil) | 7 Participants | 11 Participants | 18 Participants |
| Implant Information Final Programmed LV Configuration (Mid 2 - Prox 4) | 3 Participants | 3 Participants | 6 Participants |
| Implant Information Final Programmed LV Configuration (Mid 2 - RV Coil) | 6 Participants | 9 Participants | 15 Participants |
| Implant Information Final Programmed LV Configuration (Mid 3 - Mid 2) | 6 Participants | 3 Participants | 9 Participants |
| Implant Information Final Programmed LV Configuration (Mid 3 - Prox 4) | 7 Participants | 3 Participants | 10 Participants |
| Implant Information Final Programmed LV Configuration (Mid 3 - RV Coil)) | 5 Participants | 5 Participants | 10 Participants |
| Implant Information Final Programmed LV Configuration (Prox 4 - Mid 2) | 1 Participants | 1 Participants | 2 Participants |
| Implant Information Final Programmed LV Configuration (Prox 4 - RV Coil) | 3 Participants | 4 Participants | 7 Participants |
| Implant Information Implantation Indication (Primary Prevention) | 60 Participants | 65 Participants | 125 Participants |
| Implant Information Implantation Indication (Secondary Prevention) | 6 Participants | 8 Participants | 14 Participants |
| Implant Information Left Ventricle (LV) Lead Tip Position (Basal Anterior) | 2 Participants | 0 Participants | 2 Participants |
| Implant Information LV Lead Tip Position (Basal Ant. Septum) | 0 Participants | 0 Participants | 0 Participants |
| Implant Information LV Lead Tip Position (Basal Inferior) | 0 Participants | 0 Participants | 0 Participants |
| Implant Information LV Lead Tip Position (Basal Lateral) | 7 Participants | 11 Participants | 18 Participants |
| Implant Information LV Lead Tip Position (Basal Posterior) | 7 Participants | 2 Participants | 9 Participants |
| Implant Information LV Lead Tip Position (Basal Post. Septum) | 0 Participants | 0 Participants | 0 Participants |
| Implant Information LV Lead Tip Position (Medium Anterior) | 1 Participants | 0 Participants | 1 Participants |
| Implant Information LV Lead Tip Position (Medium Ant Septum) | 0 Participants | 0 Participants | 0 Participants |
| Implant Information LV Lead Tip Position (Medium Inferior) | 0 Participants | 0 Participants | 0 Participants |
| Implant Information LV Lead Tip Position (Medium Lateral) | 35 Participants | 46 Participants | 81 Participants |
| Implant Information LV Lead Tip Position (Medium Posterior) | 13 Participants | 14 Participants | 27 Participants |
| Implant Information LV Lead Tip Position (Medium Post Septum) | 1 Participants | 0 Participants | 1 Participants |
| Implant Information Pulse Generator (CRT-D) Position (Left) | 64 Participants | 72 Participants | 136 Participants |
| Implant Information Pulse Generator (CRT-D) Position (Right) | 2 Participants | 1 Participants | 3 Participants |
| Implant Information RA Lead Position (Atrial Appendage) | 65 Participants | 69 Participants | 134 Participants |
| Implant Information RA Lead Position (Atrial Freewall) | 1 Participants | 0 Participants | 1 Participants |
| Implant Information RA Lead Position (Atrial Septum) | 0 Participants | 3 Participants | 3 Participants |
| Implant Information RA Lead Position (Other) | 0 Participants | 1 Participants | 1 Participants |
| Implant Information RV Lead Position (Other) | 1 Participants | 0 Participants | 1 Participants |
| Implant Information RV Lead Position (RV Apex) | 38 Participants | 41 Participants | 79 Participants |
| Implant Information RV Lead Position (RV Outflow) | 2 Participants | 1 Participants | 3 Participants |
| Implant Information RV Lead Position (RV Septum) | 25 Participants | 31 Participants | 56 Participants |
| Implant Information (AV/PV & V-V Delay Optimization method) Default Parameters | 15 Participants | 23 Participants | 38 Participants |
| Implant Information (AV/PV & V-V Delay Optimization method) Echo | 0 Participants | 4 Participants | 4 Participants |
| Implant Information (AV/PV & V-V Delay Optimization method) Echo (Specify parameters) | 0 Participants | 2 Participants | 2 Participants |
| Implant Information (AV/PV & V-V Delay Optimization method) Other | 12 Participants | 12 Participants | 24 Participants |
| Implant Information (AV/PV & V-V Delay Optimization method) QuickOpt | 39 Participants | 32 Participants | 71 Participants |
| Implant Information (Base Rate) | 52.5 bpm STANDARD_DEVIATION 7.4 | 52.7 bpm STANDARD_DEVIATION 7.8 | 52.6 bpm STANDARD_DEVIATION 7.6 |
| Implant Information (Device Programming) AF Suppression (Off) | 66 Participants | 73 Participants | 139 Participants |
| Implant Information (Device Programming) AF Suppression (On) | 0 Participants | 0 Participants | 0 Participants |
| Implant Information (Device Programming) Pacing Mode (DDD) | 66 Participants | 73 Participants | 139 Participants |
| Implant Information (Device Programming) Sensor (Off) | 60 Participants | 67 Participants | 127 Participants |
| Implant Information (Device Programming) Sensor (On) | 6 Participants | 6 Participants | 12 Participants |
| Implant Information (Electrical Measures) Capture Threshold (V) at 0.5 ms | 14 units on a scale STANDARD_DEVIATION 0.8 | 1.4 units on a scale STANDARD_DEVIATION 1.1 | 1.4 units on a scale STANDARD_DEVIATION 1 |
| Implant Information (Electrical Measures) Phrenic Nerve Stimulation Threshold (V) at 0.5 ms | 4.6 units on a scale STANDARD_DEVIATION 1.4 | 4.9 units on a scale STANDARD_DEVIATION 1.6 | 4.8 units on a scale STANDARD_DEVIATION 1.4 |
| Implant Information (Electrical Measures) | 773.3 Impedance (Ω) STANDARD_DEVIATION 259.3 | 757.1 Impedance (Ω) STANDARD_DEVIATION 237.2 | 764.8 Impedance (Ω) STANDARD_DEVIATION 247.1 |
| Implant Information (Intervals Programming) AV Delay (msec) | 147.4 units on a scale STANDARD_DEVIATION 24.3 | 146.2 units on a scale STANDARD_DEVIATION 18.3 | 146.8 units on a scale STANDARD_DEVIATION 21.3 |
| Implant Information (Intervals Programming) PV Delay (msec) | 112.1 units on a scale STANDARD_DEVIATION 14.4 | 111.8 units on a scale STANDARD_DEVIATION 13.3 | 111.9 units on a scale STANDARD_DEVIATION 13.8 |
| Implant Information (Intervals Programming) VV Delay (msec) | 34.4 units on a scale STANDARD_DEVIATION 15.2 | 33.7 units on a scale STANDARD_DEVIATION 15.9 | 34.0 units on a scale STANDARD_DEVIATION 15.5 |
| Implant Information (Patient Notifier and Merlin.net Programming) Direct Alerts programmed as Protocol No | 0 Participants | 0 Participants | 0 Participants |
| Implant Information (Patient Notifier and Merlin.net Programming) Direct Alerts programmed as Protocol Yes | 65 Participants | 5 Participants | 70 Participants |
| Implant Information (Patient Notifier and Merlin.net Programming) Merlin.Net patient profile programmed as Protocol No | 1 Participants | 68 Participants | 69 Participants |
| Implant Information (Patient Notifier and Merlin.net Programming) Merlin.Net patient profile programmed as Protocol Yes | 65 Participants | 5 Participants | 70 Participants |
| Implant Information (Patient Notifier and Merlin.net Programming) Patient Notifier programmed as Protocol No | 3 Participants | 6 Participants | 9 Participants |
| Implant Information (Patient Notifier and Merlin.net Programming) Patient Notifier programmed as Protocol Yes | 63 Participants | 67 Participants | 130 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Distal 1 - Mid 2) | 26 Participants | 30 Participants | 56 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Distal 1 - Prox 4) | 2 Participants | 5 Participants | 7 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Distal 1 - RV Coil) | 7 Participants | 11 Participants | 18 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Mid 2 - Prox 4) | 3 Participants | 3 Participants | 6 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Mid 2 - RV Coil) | 6 Participants | 10 Participants | 16 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Mid 3 - Mid 2) | 6 Participants | 3 Participants | 9 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Mid 3 - Prox 4) | 7 Participants | 3 Participants | 10 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Mid 3 - RV Coil) | 5 Participants | 4 Participants | 9 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Prox 4 - Mid 2) | 1 Participants | 0 Participants | 1 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) Final LV Pacing Vector (Prox 4 - RV Coil) | 3 Participants | 4 Participants | 7 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) VV Delay (LV First) | 34 Participants | 46 Participants | 80 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) VV Delay (RV First) | 2 Participants | 1 Participants | 3 Participants |
| Implant Information (VV Delay and Final LV Pacing Vector Programming) VV Delay (Simultaneous) | 30 Participants | 26 Participants | 56 Participants |
| NYHA Class NYHA Class I | 5 participants | 4 participants | 9 participants |
| NYHA Class NYHA Class II | 24 participants | 27 participants | 51 participants |
| NYHA Class NYHA Class III | 35 participants | 41 participants | 76 participants |
| NYHA Class NYHA Class IV | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 49 Participants | 53 Participants | 102 Participants |
| Weight (kg) | 76.1 Kg STANDARD_DEVIATION 15.5 | 74.4 Kg STANDARD_DEVIATION 14.3 | 75.2 Kg STANDARD_DEVIATION 14.8 |
| Widest Intrinsic Complex (QRS) duration (msec) | 155.9 msec STANDARD_DEVIATION 23.5 | 152.5 msec STANDARD_DEVIATION 22.9 | 154.0 msec STANDARD_DEVIATION 23.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 73 | 8 / 66 |
| other Total, other adverse events | 13 / 73 | 21 / 66 |
| serious Total, serious adverse events | 37 / 73 | 28 / 66 |
Outcome results
Primary
Combined Endpoint on Patient Clinical Outcome
Combined Endpoint: * proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months * proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months
Time frame: 12 months follow up
Population: The study enrolled less than one third of expected patients as per sample size (144 out of 438). The pool of data collected during the follow up phase were spare and incomplete for the major part of patients enrolled. In addition an high number of deviations were collected during the study due to incomplete data collection. For the aforementioned reasons, the analysis for primary and secondary endpoints hasn't been performed.