Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication (PROVIDE)

February 1, 2019 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1670

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77598
        • Hall-Garcia Cardiology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with approved ICD/CRT-D indications

Description

Inclusion Criteria:

  • Primary Prevention indication for ICD/ CRT-D

Exclusion Criteria:

  • No prior documented history of spontaneous VT/VF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
PROVE Trial settings
Device: ICD/ CRT-D
Cardiac device
Experimental
Pre-selected settings
Device: ICD/ CRT-D
Cardiac device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of this study is the rate of first shock
Time Frame: Average follow-up period is 530 days
Average follow-up period is 530 days
The primary safety endpoint of this study is the rate of arrhythmic syncope
Time Frame: Average follow-up period is 530 days
Average follow-up period is 530 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Mohammad Saeed, MD, Hall-Garcia Cardiology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (ESTIMATE)

August 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 448

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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