Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication

NCT ID: NCT00743522

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

PROVE Trial settings

ICD/ CRT-D

Intervention Type DEVICE

Cardiac device

Experimental

Pre-selected settings

ICD/ CRT-D

Intervention Type DEVICE

Cardiac device

Interventions

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ICD/ CRT-D

Cardiac device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary Prevention indication for ICD/ CRT-D

Exclusion Criteria

* No prior documented history of spontaneous VT/VF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Saeed, MD

Role: PRINCIPAL_INVESTIGATOR

Hall-Garcia Cardiology Associates

Locations

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Hall-Garcia Cardiology Associates

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24112717 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29749945 (View on PubMed)

Other Identifiers

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448

Identifier Type: -

Identifier Source: org_study_id

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