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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.
The outcome measure of the study is a combined endpoint of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimal Remote Care | Active Comparator | Patient follow up is performed through remote care, remote alerts on 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. |
|
| Optimal Standard Care | No Intervention | Patient standard in clinic visits are performed every 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Care Follow up | Device | Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Endpoint on Patient Clinical Outcome | Combined Endpoint:
| 12 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Padeletti, Prof. | Azienda Ospedaliero-Universitaria Careggi | Study Chair |
| Maria Grazia Bongiorni, MD | Ospedale S.Chiara-Cisanello, Pisa | Principal Investigator |
| Gerardo Ansalone, MD | Ospedale Vannini, Roma | Principal Investigator |
| Gianluca Botto, MD | Ospedale S. Anna, Como | Principal Investigator |
| Antonio Curnis, MD | Spedali Civili, Brescia | Principal Investigator |
| Stefano Favale, Prof. | Policlinico Consorziale, Bari | Principal Investigator |
| Edoardo Gronda, MD | Multimedica IRCCS, Milano | Principal Investigator |
| Roberto Verlato, MD | Ospedale Pietro Cosma, Camposampiero (PD) | Principal Investigator |
| Alessandro Proclemer, MD | Ospedale S.M. della Misericordia, Udine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa di Cura "Montevergine" | Mercogliano | Avellino | Italy | |||
| Ospedale Pietro Cosma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18975066 | Background | Santini M, Ricci RP, Lunati M, Landolina M, Perego GB, Marzegalli M, Schirru M, Belvito C, Brambilla R, Guenzati G, Gilardi S, Valsecchi S. Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes. J Interv Card Electrophysiol. 2009 Jan;24(1):53-61. doi: 10.1007/s10840-008-9321-3. Epub 2008 Oct 31. | |
| 18811805 |
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5 subjects not randomized. 139 Subjects randomized in 2 arms
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| ID | Title | Description |
|---|---|---|
| FG000 | Optimal Remote Care | Patient follow up is performed through remote care, remote alerts on 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 |
| FG001 | Optimal Standard Care | Patient standard in clinic visits are performed every 6 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Combined Endpoint on Patient Clinical Outcome | Combined Endpoint:
| 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. | Posted | 12 months follow up |
|
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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 | Optimal Standard Care | Patient standard in clinic visits are performed every 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Denaro, Sr. Director Clinical Site Management | Abbott | alessandra.denaro@abbott.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Luca Santini, MD |
| University of Rome Tor Vergata |
| Principal Investigator |
| Alessandro Capucci, Prof. | Azienda Ospedaliero, Universitaria Ospedali Riuniti | Principal Investigator |
| Francesco Solimene, MD | Casa di Cura "Montevergine", Mercogliano (AV) | Principal Investigator |
| Camposampiero |
| Padova |
| Italy |
| Osp. S.Raffaele Giglio | Cefalù | Palermo | Italy |
| Presidio Ospedaliero Riunito di Ciriè | Cirié | Torino | Italy |
| Presidio Ospedaliero di Conegliano | Conegliano | Treviso | Italy |
| Casa di Cura Pederzoli | Peschiera del Garda | Verona | Italy |
| Azienda Ospedaliero Universitaria "Ospedali Riuniti" | Ancona | Italy |
| Policlinico Consorziale | Bari | Italy |
| Spedali Civili | Brescia | Italy |
| Ospedale Ferrarotto Vittorio Emanuele | Catania | Italy |
| Ospedale S. Anna | Como | Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | Italy |
| Azienda Ospedaliera dei Colli - Ospedale Monaldi | Naples | Italy |
| Ospedale Guglielmo da Saliceto | Piacenza | Italy |
| Ospedale S. Chiara - Cisanello | Pisa | Italy |
| Ospedale Vannini | Roma | Italy |
| Policlinico Tor Vergata | Roma | Italy |
| Ospedale di Belcolle | Viterbo | Italy |
| Background |
| Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x. |
| 21449992 | Background | Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, McRae S, Toledo GB, Sarkar S, Hettrick DA; FAST Study Investigators. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). Congest Heart Fail. 2011 Mar-Apr;17(2):51-5. doi: 10.1111/j.1751-7133.2011.00220.x. Epub 2011 Mar 21. |
| 20569704 | Background | Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034. |
| 21080835 | Background | Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG001 | Optimal Standard Care | Patient standard in clinic visits are performed every 6 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight (kg) | Weight in Remote Care Arm was available only for 65 subjects instead of 66. | Mean | Standard Deviation | Kg |
|
| Height (cm) | info not available for the entire population | Mean | Standard Deviation | cm |
|
| NYHA Class | New York Heart Association (NYHA) functional classification for heart failure. It places patients in four categories based on the limitation during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain. Class I: Cardiac disease without limitation of physical activity. Class II: Cardiac disease with slight limitation of physical activity. Class III: Cardiac disease with marked limitation of physical activity. Class IV: Cardiac disease with inability to carry on any physical activity without discomfort. | Number | participants |
|
| Widest Intrinsic Complex (QRS) duration (msec) | data not available for the entire population | Data not available for the entire study population | Mean | Standard Deviation | msec |
|
| Current Medication | Count of Participants | Participants |
|
| Etiology of cardiovascular disease (Ischemic/Non Ischemic) | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Implant Information | Count of Participants | Participants |
|
| Implant Information (Electrical Measures) | Measure Description: data not available for the entire population | Mean | Standard Deviation | units on a scale |
|
| Implant Information (Electrical Measures) | Measure Analysis Population Description: data not available for the entire population | Mean | Standard Deviation | Impedance (Ω) |
|
| Implant Information (AV/PV & V-V Delay Optimization method) | Atrioventricular (AV/PV) and interventricular (VV) delay optimization in pacing devices can be performed using different methods. Echo: standard AV/PV and/or VV delay optimization guided by Doppler echocardiogram measurements of the maximum aortic velocity time integral (aortic VTI). Echo (Specify parameters): AV/PV and/or VV delay optimization guided by Doppler according to specific parameters. Automated Optimization (QuickOpt™): proprietary algorithm for AV/PV and VV delay optimization based on intracardiac electrogram (IEGM) measurement. Default Parameters: Standard device parameters. | Count of Participants | Participants |
|
| Implant Information (Device Programming) | Count of Participants | Participants |
|
| Implant Information (Base Rate) | Measure Analysis Population Description: data not available for the entire population | Mean | Standard Deviation | bpm |
|
| Implant Information (Intervals Programming) | data not available for the entire population | Mean | Standard Deviation | units on a scale |
|
| Implant Information (VV Delay and Final LV Pacing Vector Programming) | The VV Delay is the interval between right ventricular (RV) and left ventricular (LV)activation; Simultaneous (VV Delay = 0), LV First (left pre-activation) o RV First (right pre-activation) are programmable configurations. In addition the LV Pacing Vector is programmable in 10 different configurations to optimize the LV contraction and the resynchronization of the two ventricles. | Count of Participants | Participants |
|
| Implant Information (Patient Notifier and Merlin.net Programming) | Data not available for the entire study population | data not available for the entire population | Count of Participants | Participants |
|
Patient standard in clinic visits are performed every 6 months.
| OG001 | Remote Care | Patients perform a 6 and 18 (optional) months Remote Follow Up and 12 and 24 months in clinic visits |
|
| 10 |
| 73 |
| 37 |
| 73 |
| 13 |
| 73 |
| EG001 | Remote Care | Patients perform a 6 and 18 (optional) months Remote Follow Up and 12 and 24 months in clinic visits | 8 | 66 | 28 | 66 | 21 | 66 |
| Atrial Flutter | Cardiac disorders | MedDRA 10.0 |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 |
|
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 10.0 |
|
| Heart Failure | Cardiac disorders | MedDRA 10.0 |
|
| Pulmonary Edema | Cardiac disorders | MedDRA 10.0 |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 10.0 |
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| Inguinal Hernia | Gastrointestinal disorders | MedDRA 10.0 |
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| Intestinal Perforation | Gastrointestinal disorders | MedDRA 10.0 |
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| Cardiac Death | General disorders | MedDRA 10.0 |
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| Infected Skin Ulcer | Infections and infestations | MedDRA 10.0 |
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| Urosepsis | Infections and infestations | MedDRA 10.0 |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 |
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| Implant Site Infection | Injury, poisoning and procedural complications | MedDRA 10.0 |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 |
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| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 10.0 |
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| Respiratory Failure | Metabolism and nutrition disorders | MedDRA 10.0 |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Carotid Artery Thrombosis | Nervous system disorders | MedDRA 10.0 |
|
| Colonic Polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
|
| Coxarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Non ST segment elevation acute coronary syndrome | Cardiac disorders | MedDRA 10.0 |
|
| Hemodynamic Instability | General disorders | MedDRA 10.0 |
|
| Sudden Death, Cause Unknown | Cardiac disorders | MedDRA 10.0 |
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| Unknown Cause of Death | General disorders | MedDRA 10.0 |
|
| Pocket Formation of Decubitus | Injury, poisoning and procedural complications | MedDRA 10.0 |
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| Medical Device Replacement | Injury, poisoning and procedural complications | MedDRA 10.0 |
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| Hypernatremia | Metabolism and nutrition disorders | MedDRA 10.0 |
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| Renal Venous Congestion | Metabolism and nutrition disorders | MedDRA 10.0 |
|
| Osteomyelitis of the foot | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
|
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
|
| Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
|
| Prostate Cancer Metastatic | Reproductive system and breast disorders | MedDRA 10.0 |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
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| Angioplasty | Surgical and medical procedures | MedDRA 10.0 |
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| Aortic Valve Replacement | Surgical and medical procedures | MedDRA 10.0 |
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| Foot Amputation | Surgical and medical procedures | MedDRA 10.0 |
|
| Skin Graft | Surgical and medical procedures | MedDRA 10.0 |
|
| Cardiogenic Shock | Vascular disorders | MedDRA 10.0 |
|
| Lead Dislodgement | Product Issues | MedDRA 10.0 |
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| Cardiac Failure | Cardiac disorders | MedDRA 10.0 |
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| Chest Pain | Cardiac disorders | MedDRA 10.0 |
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| Dyspnea | Cardiac disorders | MedDRA 10.0 |
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| Pulmonary Congestion | Cardiac disorders | MedDRA 10.0 |
|
| Pulmonary Edema | Cardiac disorders | MedDRA 10.0 |
|
| Hypothyroidism | Endocrine disorders | MedDRA 10.0 |
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| Asthenia | General disorders | MedDRA 10.0 |
|
| Chest Crushing | Injury, poisoning and procedural complications | MedDRA 10.0 |
|
| Angiogram | Investigations | MedDRA 10.0 |
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| Sinus Rhythm | Investigations | MedDRA 10.0 |
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| Device Capturing Issue | Product Issues | MedDRA 10.0 |
|
| Device Electrical Impedance Issue | Product Issues | MedDRA 10.0 |
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| Device Inappropriate shock delivery | Product Issues | MedDRA 10.0 |
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| Device Malfunction | Product Issues | MedDRA 10.0 |
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| Device Telemetry Issue | Product Issues | MedDRA 10.0 |
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| Lead Dislodgement | Product Issues | MedDRA 10.0 |
|
| Mobile Medical Application Issue | Product Issues | MedDRA 10.0 |
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| Oversensing | Product Issues | MedDRA 10.0 |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 10.0 |
|
| Hematuria | Reproductive system and breast disorders | MedDRA 10.0 |
|
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| No |
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| No |
|