Clinical trial NCT00661037: SAFEty of Two Strategies of ICD Management at Implantation
Official title: SAFEty of Two Strategies of ICD Management at Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Fibrillation
Ventricular Flutter
Sudden Cardiac Death
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 2120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.

Brief summary: The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable cardioverter defibrillator

Detailed description: The standardized requirements for implantable cardioverter defibrillator (ICD) include defibrillation testing (DT), consisting in induction and termination of ventricular fibrillation (VF). An effective DT has historically been considered part of standard procedures at implant. Nevertheless, implant techniques and technology have evolved during years and nowadays deviations are frequent in clinical practice mainly due to the fact that physicians are seriously concerned about the risk of severe complications related to DT. However, the practice of not performing DT is arbitrary and its safety is yet unproven. This observational study will assess the safety of the two strategies adopted at ICD implant: induction (including patients who undergo DT at implant) and non-induction (including patients who do not undergo DT at implant. No deviation from the centres' current practice in choosing to perform or not perform DT is introduced by this study protocol. The study considers consecutive patients undergoing first implant of ICD

Eligibility criteria: Inclusion Criteria:

* first implantation of ICD or CRT-D
* Patients undergoing upgrade to ICD or CRT-D from pacemaker
* Patients undergoing upgrade to CRT-D from CRT
* Age 18 or above, or legal age to give written informed consent

Exclusion Criteria:

* Patients who do not give consent to treat their data.

Primary outcomes:
measure: Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up
timeFrame: 2 years
Secondary outcomes:
measure: Severe Intra-operative Complications
timeFrame: Acute (ICD implant)
measure: Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up
timeFrame: 2 years
Other outcomes:
Locations:
city: Lavagna
country: Italy
facility: Ospedali del Tigullio, via Don Bobbio 25
Study officials:
affiliation: Ospedali del Tigullio
name: Michele Brignole, MD
role: STUDY_CHAIR
References:
citation: Brignole M, Occhetta E, Bongiorni MG, Proclemer A, Favale S, Iacopino S, Calo L, Vado A, Buja G, Mascioli G, Quartieri F, Tritto M, Parravicini U, Castro A, Tomasi C, Villani GQ, D'Acri MG, Klersy C, Gasparini M; SAFE-ICD Study Investigators. Clinical evaluation of defibrillation testing in an unselected population of 2,120 consecutive patients undergoing first implantable cardioverter-defibrillator implant. J Am Coll Cardiol. 2012 Sep 11;60(11):981-7. doi: 10.1016/j.jacc.2012.05.014. Epub 2012 Aug 1.