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OpenTrials
Completed

NCT Number: NCT00743522

Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication

Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life. Previous studies have suggested that one or more sets of aggressive device parameter settings may reduce the total number of shocks in primary prevention patients. In addition to shock therapies, antitachycardia pacing (ATP) is also available in ICDs to treat VT. The PROVIDE trial aims to prospectively study the effect of high detection rates, prolonged detection intervals, aggressive SVT discriminators, and extensive ATP therapy in prolonging the time to first shock in primary prevention patients.

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hall-Garcia Cardiology Associates

Houston, Texas, 77598, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary Prevention indication for ICD/ CRT-D

Exclusion criteria

  • No prior documented history of spontaneous VT/VF

Treatment and study plan

ICD/ CRT-D

Device

Cardiac device

Primary outcomes

  1. The primary endpoint of this study is the rate of first shock

    Time frame: Average follow-up period is 530 days

  2. The primary safety endpoint of this study is the rate of arrhythmic syncope

    Time frame: Average follow-up period is 530 days

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Programming Implantable Cardioverter Defibrillators (ICDs) in Patients With Primary Prevention Indication to Prolong Time to First Shock

Acronym: PROVIDE

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 29, 2008
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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