Expired Study
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Houston, Texas 77598


Purpose:

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.


Criteria:

Inclusion Criteria: - Primary Prevention indication for ICD/ CRT-D Exclusion Criteria: - No prior documented history of spontaneous VT/VF


Study is Available At:


Original ID:

448


NCT ID:

NCT00743522


Secondary ID:


Study Acronym:

PROVIDE


Brief Title:

Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott Medical Devices


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

1670


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:September 2008
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:September 2011
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 1, 2019
First Received Date:August 28, 2008

Study Outcomes

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

Study Interventions

Intervention Type:Device
Name:ICD/ CRT-D
Description:Cardiac device
Arm Name:Control

Study Arms

Study Arm Type:Other
Arm Name:Experimental
Description:Pre-selected settings
Study Arm Type:Other
Arm Name:Control
Description:PROVE Trial settings

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott Medical Devices

Samples and Retentions

Study Population: Patients with approved ICD/CRT-D indications
Sample Method:Probability Sample

Study References

Reference Type:Results Reference
Citation: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.
PMID:24112717

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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