DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry

NCT02076789 | Unknown

• 1 other identifier: 72/2013/O/Oss
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 32

Brief Summary

This study has been designed to prospectively estimate long term complication rates (12-months and 5-years) in patients undergoing Implantable Cardioverter Defibrillator (ICD) replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies; the study also evaluates the predictors of complications, the patient's management before and during the replacement procedure in clinical practice and the estimated costs related to the use of health care resources.

Conditions

Device Replacement; Device Upgrade; Long-term Postoperative Complications; Resource Consumption and Associated Costs After Device Replacement/Upgrade

Keywords

Device Replacement; Device Upgrade; Long-term Postoperative Complications; Resource consumption and associated costs after device replacement/upgrade

Outcome Measures

Primary Outcomes (1)

• Rate of complications associated with the ICD replacement / upgrade that occur during a period of 12 months

  The primary outcome measure of this study is to estimate, at 12-months follow up, the percentage of subjects undergoing ICD generator replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies, experiencing one of the pre-defined complications.

  12 months

Secondary Outcomes (3)

• Baseline patient's characteristics (clinical history and drug therapy) for subjects undergoing ICD replacement/upgrade

  60 months

• - Rate of complications associated with the ICD replacement / upgrade that occur during a very long-term period

  60 months

• Long-term costs of ICD/upgrade procedure

  60 months

Study Arms (1)

ICD generator replacement

Patients with standard indications to ICD generator replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing ICD generator replacement, with and without a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies (consecutive patients)

You may qualify if:

• Patient implanted with a CardiacResynchronizationTherapy-Defibrillator or single chamber/dual chambers ICD device (any commercially available generator or lead can be included).
• Patient with standard indications to ICD generator replacement according to the investigators' clinical assessment.
• Patient must be able to attend all required follow-up visits at the study center.

You may not qualify if:

• Patient is less than 18 years of age.
• Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
• Patient life expectancy is less than 12 months.
• Patient is participating in another clinical study that may have an impact on the study endpoints.

Sponsors & Collaborators

• Mauro Biffi: lead

Study Sites (32)

Ospedale di Venere

Carbonara di Bari, Bari, 70131, Italy

RECRUITING

A.O. "Papa Giovanni XXIII"

Bergamo, BG, 24123, Italy

RECRUITING

Ospedale di Bentivoglio

Bentivoglio, Bologna, 40010, Italy

RECRUITING

Ospedale SS. Annunziata

Cento, Ferrara, 44011, Italy

RECRUITING

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, 71013, Italy

RECRUITING

Ospedale "Maurizio Bufalini"

Cesena, Forlì, 47521, Italy

RECRUITING

Ospedale Maggiore

Lodi, LO, 26900, Italy

RECRUITING

Ospedale Civile S.Agostino-Estense

Baggiovara, Modena, Italy

RECRUITING

A.O.U.P. "Paolo Giaccone"

Palermo, PA, 90010, Italy

RECRUITING

Policlinico Universitario "Agostino Gemelli"

Rome, RM, 00100, Italy

RECRUITING

Ospedale Santa Maria alle Scotte

Siena, SI, 53100, Italy

RECRUITING

Casa di Cura "Villa Verde"

Taranto, TA, 74121, Italy

RECRUITING

Ospedale "San Donato"

Arezzo, 52100, Italy

RECRUITING

Ospedale Maggiore

Bologna, 40133, Italy

RECRUITING

Azienda Ospedaliera Universitaria , Policlinico Sant'Orsola

Bologna, 40138, Italy

RECRUITING

Università Cattolica del Sacro Cuore

Campobasso, Italy

RECRUITING

Ospedale Cuneo

Cuneo, 12100, Italy

RECRUITING

Ospedale "San Giuseppe"

Empoli, 50053, Italy

RECRUITING

A.O.S.Anna

Ferrara, 44124, Italy

RECRUITING

Ospedale "Morgagni-Pierantoni"

Forlì, 47121, Italy

RECRUITING

Ospedale "Padre Antero Micone" - Sestri Ponente

Genova, 16153, Italy

RECRUITING

Ospedale della Misericordia

Grosseto, 58100, Italy

RECRUITING

Clinica Mediterranea

Napoli, 80122, Italy

RECRUITING

Ospedale Monaldi SUN

Napoli, Italy

RECRUITING

A.O. Santa Maria della Misericordia

Perugia, Italy

RECRUITING

Azienda Ospedali Riuniti Marche Nord

Pesaro, 61121, Italy

RECRUITING

Ospedale "Santa Maria delle Croci"

Ravenna, 48121, Italy

RECRUITING

Ospedale Santa Maria Nuova

Reggio Emilia, Italy

RECRUITING

Ospedale degli Infermi

Rimini, 47900, Italy

RECRUITING

Policlinico Casilino

Roma, 00169, Italy

RECRUITING

A.O. San Giovanni di Dio e Ruggi di Aragona

Salerno, 84131, Italy

RECRUITING

Ospedale Santa Maria di Cà Foncello

Treviso, Italy

RECRUITING

Related Publications (4)

• Zoni-Berisso M, Martignani C, Ammendola E, Narducci ML, Caruso D, Miracapillo G, Notarstefano P, Carinci V, Pierantozzi A, Ciaramitaro G, Calo L, Zennaro M, Infusino T, Ferretti C, Sassone B, Licciardello G, Setti S, Terzaghi C, Malacrida M, Biffi M. Mortality after cardioverter-defibrillator replacement: Results of the DECODE survival score index. Heart Rhythm. 2021 Mar;18(3):411-418. doi: 10.1016/j.hrthm.2020.11.024. Epub 2020 Nov 27.

  PMID: 33249200 DERIVED

• Biffi M, Ammendola E, Menardi E, Parisi Q, Narducci ML, De Filippo P, Manzo M, Stabile G, Potenza DR, Zanon F, Quartieri F, Rillo M, Saporito D, Zaca V, Berisso MZ, Bertini M, Tumietto F, Malacrida M, Diemberger I. Real-life outcome of implantable cardioverter-defibrillator and cardiac resynchronization defibrillator replacement/upgrade in a contemporary population: observations from the multicentre DECODE registry. Europace. 2019 Oct 1;21(10):1527-1536. doi: 10.1093/europace/euz166.

  PMID: 31209482 DERIVED

• Zanon F, Martignani C, Ammendola E, Menardi E, Narducci ML, DE Filippo P, Santamaria M, Campana A, Stabile G, Potenza DR, Pastore G, Iori M, LA Rosa C, Biffi M. Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement. J Cardiovasc Electrophysiol. 2016 Jul;27(7):840-5. doi: 10.1111/jce.12990. Epub 2016 Jun 17.

  PMID: 27094359 DERIVED

• Diemberger I, Parisi Q, De Filippo P, Narducci ML, Zanon F, Potenza DR, Ciaramitaro G, Malacrida M, Boriani G, Biffi M. Detect Long-term Complications After ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry. Clin Cardiol. 2015 Oct;38(10):577-84. doi: 10.1002/clc.22440. Epub 2015 Aug 18.

  PMID: 26282191 DERIVED

Central Study Contacts

Mauro Biffi

CONTACT

0039 051 636 3434; decode.registry@libero.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dirigente Medico di Cardiologia

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

IT (32)