Clinical trial NCT06311149: Multicenter Evaluation of Patients Using LATITUDE Monitoring System
Official title: Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Failure
Sudden Cardiac Death
Keywords: Cardiac implantable electrical device
Implantable cardioverter defibrillator
Pacemaker
Cardiac resynchronization therapy
Subcutaneous defibrillator
Implantable cardiac monitor
Remote monitoring
Latitude monitoring system
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be recruited from the general patient population of the participating centers who are

* receiving diagnosis or treatment using a device monitored through the LATITUDE monitoring system and
* fulfilling all inclusion criteria and none of the exclusion criteria.

Brief summary: The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.

The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.

The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle.


Eligibility criteria: Inclusion Criteria:

* Subject is willing and capable of providing informed consent to collect/store/process personal health information by the sponsor or such consent is provided by a legally designated representative, if required by local law or regulation.
* Subject is:

  1. prospectively scheduled for receiving a device monitored through the LATITUDE monitoring system
  2. retrospectively enrolled after having received a device monitored through the LATITUDE monitoring system

Exclusion Criteria:

* Subject foreseen not to be followed at the enrolling center for at least 1 year after having received the device.
* Subject is receiving a device that is not approved for commercial use at the time of procedure.

Primary outcomes:
measure: Mortality
timeFrame: 10 years
Secondary outcomes:
measure: Hospitalization
timeFrame: 10 years
measure: Device therapy
timeFrame: 10 years
measure: Device-related complications
timeFrame: 10 years
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Roma
country: Italy
facility: Ospedale "G.B. Grassi"
Study officials:
affiliation: Azienda Ospedaliera Universitaria di Ferrara
name: Matteo Bertini, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. Erratum In: Eur Heart J. 2022 May 1;43(17):1651. doi: 10.1093/eurheartj/ehac075.
citation: Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.
citation: Maines M, Tomasi G, Moggio P, Peruzza F, Catanzariti D, Angheben C, Simoncelli M, Degiampietro M, Piffer L, Valsecchi S, Del Greco M. Implementation of remote follow-up of cardiac implantable electronic devices in clinical practice: organizational implications and resource consumption. J Cardiovasc Med (Hagerstown). 2020 Sep;21(9):648-653. doi: 10.2459/JCM.0000000000001011.
citation: Palmisano P, Melissano D, Zanotto G, Perego GB, Toselli T, Landolina M, Ricci RP; Italian Association of Arrhythmology, Cardiac Pacing (AIAC). Change in the use of remote monitoring of cardiac implantable electronic devices in Italian clinical practice over a 5-year period: results of two surveys promoted by the AIAC (Italian Association of Arrhythmology and Cardiac Pacing). J Cardiovasc Med (Hagerstown). 2020 Apr;21(4):305-314. doi: 10.2459/JCM.0000000000000950.