SAFEty of Two Strategies of ICD Management at Implantation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

NCT03495297

Ventricular Arrythmia

ACTIVE_NOT_RECRUITING NA

TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

NCT00345592

Heart Failure, Congestive

COMPLETED PHASE4

Quick ICD Study: Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary ?

NCT00180362

Cardiac Arrest

COMPLETED PHASE4

Comparison of a MAGNET Protocol Versus "off-on" Protocol for Patients With Implantable Cardioverter Defibrillators

NCT01599065

Sudden Cardiac Death Arrhythmia Heart Failure

COMPLETED

Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

NCT00947310

Primary Prevention of Sudden Cardiac Arrest

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventricular Fibrillation Ventricular Flutter Sudden Cardiac Death

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Patients having VF induction with shock termination at implant

Implantable defibrillator

Intervention Type DEVICE

Implantable defibrillator to reduce ventricular arrhythmias via shock.

2

Patients not having VF induction at implant or during follow-up

Implantable defibrillator

Intervention Type DEVICE

Implantable defibrillator to reduce ventricular arrhythmias via shock.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantable defibrillator

Implantable defibrillator to reduce ventricular arrhythmias via shock.

Intervention Type DEVICE

Implantable defibrillator

Implantable defibrillator to reduce ventricular arrhythmias via shock.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Not applicable. All devices allowed. Not applicable. All devices allowed.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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