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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00832975
Other study ID # CR08003ES
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2008
Est. completion date December 2013

Study information

Verified date February 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.


Description:

The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.


Recruitment information / eligibility

Status Completed
Enrollment 157
Est. completion date December 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)

- Patient has signed the study specific Informed consent document.

- Patient is older than 18 years of age

Exclusion Criteria:

- Patient has a permanent Atrial Fibrillation

- Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.

- Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.

- Patient requires cardiac resynchronization

- Patient has Brugada Syndrome

- Patient has long QT Syndrome

- Patient has a device replacement;

- Patient is pregnant or nursing

- Patient is unable to attend the follow-up visits

Study Design


Locations

Country Name City State
Spain Hospital Universitario Puerta de Hierro Madrid
Spain Hospital Clínico Universitario Virgen de la Victoria Málaga

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec 24 months
Secondary Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure 24 months
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