Multicenter Evaluation of Patients Using LATITUDE Monitoring System

NCT06311149 | Recruiting

• 1 other identifier: 479/2023/Oss/AOUFe
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality

  10 years

Secondary Outcomes (3)

• Hospitalization

  10 years

• Device therapy

  10 years

• Device-related complications

  10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• prospectively scheduled for receiving a device monitored through the LATITUDE monitoring system
• retrospectively enrolled after having received a device monitored through the LATITUDE monitoring system

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (3)

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, 44124, Italy

RECRUITING

Policlinico Federico II

Napoli, Italy

RECRUITING

Ospedale "G.B. Grassi"

Roma, Italy

RECRUITING

Related 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-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19.

  PMID: 37211145 BACKGROUND

• 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.

  PMID: 34455430 BACKGROUND

• 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.

  PMID: 36017572 BACKGROUND

• 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.

  PMID: 32628426 BACKGROUND

• 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.

  PMID: 32073430 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Officials

• Matteo Bertini, Prof

  Azienda Ospedaliera Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Bertini, Prof

CONTACT

+390532236111; doc.matber@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2043
• Study Completion (Estimated): December 31, 2043
• Last Updated: August 12, 2024

Record last verified: 2023-12

Locations

IT (3)