SAFEty of Two Strategies of ICD Management at Implantation

NCT00661037 | Completed Results DMC

• 1 other identifier: 2007_SI
• Study Type: observational
• Target: 2,120
• Locations: 1 country
• Sites: 1

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

Conditions

Ventricular Fibrillation; Ventricular Flutter; Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up

  * Severe implant-related\* complications at ICD implants among the following: * Survival from cardiopulmonary arrest due to VF requiring 3 or more consecutive external shocks for termination or due to electro-mechanical dissociation. * Transient ischemic attack or stroke, * Cardiogenic shock, * Pulmonary edema, * Embolic events, * Anoxic coma * Pericardial tamponade * Death. * Events at follow up: * Sudden cardiac death (defined as witnessed unexpected death occurring \<1 hour from symptoms onset or unwitnessed during sleep) * Resuscitation after ineffective documented appropriate ICD shocks * Implant related events are considered as those listed above, occurring during the implant procedure in the timeframe betweend device poket insertion and patient exit from the cath-lab, as well as those events occurring after the patient exit from the cath-lab that, after review from the event adjudication committee, have been classified as related to the implant procedure.

  2 years

Secondary Outcomes (2)

• Severe Intra-operative Complications

  Acute (ICD implant)

• Sudden Cardiac Death at Follow up or Resusciation After Ineffective Documented Appropriate ICD Shocks at Follow up

  2 years

Study Arms (2)

1

Patients having VF induction with shock termination at implant

Device: Implantable defibrillator

2

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

Device: Implantable defibrillator

Interventions

Implantable defibrillator DEVICE

Implantable defibrillator to reduce ventricular arrhythmias via shock.

Also known as: Not applicable. All devices allowed.

1

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 having the risk of life threatening arrhythmias and indicated for the implant of an implantable cardioverter defibrillator.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Ospedali del Tigullio, via Don Bobbio 25

Lavagna, 16033, Italy

Location

Related Publications (1)

• 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.

  PMID: 22858384 DERIVED

MeSH Terms

Conditions

Ventricular Fibrillation; Ventricular Flutter; Death, Sudden, Cardiac

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Results Point of Contact

• Title: Dr Michele Brignole
• Organization: Ospedali del Tigullio, Lavagna, Italy

aritmo@asl4.liguria.it

0185 329567329

Study Officials

• Michele Brignole, MD

  Ospedali del Tigullio

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 18, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 21, 2017
• Results First Posted: June 20, 2017

Record last verified: 2017-06

Locations

IT (1)