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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06311149
Other study ID # 479/2023/Oss/AOUFe
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2043

Study information

Verified date December 2023
Source University Hospital of Ferrara
Contact Matteo Bertini, Prof
Phone +390532236111
Email doc.matber@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date December 31, 2043
Est. primary completion date December 31, 2043
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Locations

Country Name City State
Italy Azienda Ospedaliero-Universitaria di Ferrara Ferrara
Italy Policlinico Federico II Napoli

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Te — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality 10 years
Secondary Hospitalization Hospitalization 10 years
Secondary Device therapy For therapeutic devices, e.g. ICDs, CRT-Ds, S-ICDs) 10 years
Secondary Device-related complications Complication 10 years
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