Multicenter Evaluation of Patients Using LATITUDE Monitoring System

Heart Failure Clinical Trial

— Multitude  

Official title:

Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311149
• Other study ID #: 479/2023/Oss/AOUFe
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiovascular Diseases
• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

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