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CompletedNCT00743522PROVIDEUpdated Feb 4, 2019

Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication

An observational study in Shock, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,670
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Shock

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Keywords

  • Reducing shocks
03

In context

Shock

916 studies on the registry are indexed under Shock; 176 are open to participants now.

This study's enrollment of 1,670 is above the median of 91 across 346 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with approved ICD/CRT-D indications

Inclusion criteria

  • Primary Prevention indication for ICD/ CRT-D

Exclusion criteria

Exclusion Criteria:

  • No prior documented history of spontaneous VT/VF
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,670 participants (actual)
Patient registry
No

Groups and cohorts

  • Control

    PROVE Trial settings

    Device: ICD/ CRT-D

  • Experimental

    Pre-selected settings

    Device: ICD/ CRT-D

Interventions

  • DeviceICD/ CRT-D

    Cardiac device

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What researchers measure

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

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Study locations

1 site
  • Hall-Garcia Cardiology Associates
    Houston, Texas 77598, United States
08

References and documents

Publications

  • Saeed M, Hanna I, Robotis D, Styperek R, Polosajian L, Khan A, Alonso J, Nabutovsky Y, Neason C. Programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock: results from the PROVIDE study. J Cardiovasc Electrophysiol. 2014 Jan;25(1):52-9. doi: 10.1111/jce.12273. Epub 2013 Sep 24. PubMed 24112717 ↗
  • Sanders P, Connolly AT, Nabutovsky Y, Fischer A, Saeed M. Increased Hospitalizations and Overall Healthcare Utilization in Patients Receiving Implantable Cardioverter-Defibrillator Shocks Compared With Antitachycardia Pacing. JACC Clin Electrophysiol. 2018 Feb;4(2):243-253. doi: 10.1016/j.jacep.2017.09.004. Epub 2017 Nov 15. PubMed 29749945 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00743522
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Aug 29, 2008
Start date
Sep 2008
Primary completion
Sep 2011
Completion
Dec 2011
Last update
Feb 4, 2019

Study contacts

Mohammad Saeed, MD
principal investigator · Hall-Garcia Cardiology Associates

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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