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Cardioverter Defibrillator Replacement With Induction of Ventricular Fibrillation and Defibrillation Testing (SIMPLER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02513030
Recruitment Status : Unknown
Verified October 2017 by Prof. Michael Glikson, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : July 31, 2015
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Michael Glikson, Sheba Medical Center

Brief Summary:
The SIMPLE study was a large one, and lasted quite a few years due to its design as a randomized controlled trial and the follow up needed to reach an endpoint. The investigators aim to conduct an observational pilot study looking at frequency of positive findings during VF testing . The comparator will be the rate of findings during testing in the Simple trial. If the investigators will find an increased rate of findings (significantly higher than in the Simple trial ) it may set the stage for a randomized controlled trial of replacements , along the line of the Simple trial , or to a recommendation to continue VF testing in all ICD replacements.

Condition or disease Intervention/treatment
Defibrillation Capacity of Defibrilators After Replacement Procedure: Defibrillation testing during ICD replacement

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardioverter Defibrillator Replacement With Induction of Ventricular Fibrillation and Defibrillation Testing
Study Start Date : August 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Replacement of defibrillator Procedure: Defibrillation testing during ICD replacement



Primary Outcome Measures :
  1. Failure of DT at a single shock at 10 J below maximal capacity of the device [ Time Frame: During replacement ]

Secondary Outcome Measures :
  1. Rate of system malfunction requiring intervention [ Time Frame: During procedure ]
  2. Number of patients in which DT testing produced arrhythmia or ahock during procedure change [ Time Frame: 6 month ]
  3. Rate of lead failure or battery failure [ Time Frame: 6 month ]
  4. Lead management decisions in cases where lead failure is identified (adding a new lead, extraction and etc.) [ Time Frame: During procedure ]
  5. Number of patients with subsequent device infection and opted management (i.e. association with type of antibiotics, IV vs. PO, use of same pouch and etc.) [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an ICD or CRT-D undergoing pocket generator replacement.
Criteria

Inclusion Criteria:

1. Patients with an ICD or CRT-D undergoing pocket generator replacement.

Exclusion Criteria:

  1. If there is an absolute contraindication to DFT testing

    • NYHA class IV
    • AF > 24 hours unless on oral anticoagulation or negative TEE
    • Recent anoxic brain injury
  2. Obvious lead malfunction (i.e. short V-V intervals, inappropriate shock for noise, clear fracture on CXR and etc.)
  3. Unwilling to provide written informed consent
  4. Unavailable for Follow-up
  5. Pregnancy (or women of child-bearing potential not taking or willing to take an effective method of contraception).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513030


Contacts
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Contact: Michael Glikson, MD 972-3-530-5330 michael.glikson@sheba.health.gov.il
Contact: Eyal Nof, MD 972-3-530-5330 eyal.nof@sheba.health.gov.il

Locations
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Israel
Arrythmia Service Center Recruiting
Ramat Gan, Israel
Principal Investigator: Michael Glikson, MD         
Sub-Investigator: Roy Beinart, MD         
Sub-Investigator: Eyal Nof, MD         
Sub-Investigator: Osnat Gurevitz, MD         
Sub-Investigator: David Bar Lev, MD         
Sponsors and Collaborators
Sheba Medical Center
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Responsible Party: Prof. Michael Glikson, Director of Davidai Arrhythmia Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02513030    
Other Study ID Numbers: SHEBA-15-2033-MG-CTIL
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes