Overview

This trial is active, not recruiting.

Conditions ventricular tachycardia, atrial fibrillation
Sponsor St. Jude Medical
Start date January 2009
End date July 2013
Trial size 150 participants
Trial identifier NCT00832975, CR08003ES

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Slow Ventricular Tachycardia Episodes devices detected (between 120-150 bpm and > 30sec) AF Episodes devices detected (> 30 sec)
time frame: 24 months

Secondary Outcomes

Measure
Cardiovascular Mortality Hospitalization rate due to cardiovascular reasons or heart failure Slow Ventricular Tachycardia and Atrial fibrillation Episodes Cardiac Symptoms
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has been implanted with a SJM ICD, mono or bicameral according the ACC/AHA/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 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

Additional Information

Official title Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With a DAI.
Principal investigator Ignacio Fernández Lozano, PhD.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by St. Jude Medical.