Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication

Shock Clinical Trial

— PROVIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743522
• Other study ID #: 448
• Status: Completed
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1670
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary Prevention indication for ICD/ CRT-D

Exclusion Criteria:

• No prior documented history of spontaneous VT/VF

Related Conditions & MeSH terms

• Shock

Intervention

Device:
• ICD/ CRT-D
Cardiac device

Locations

Country	Name	City	State
United States	Hall-Garcia Cardiology Associates	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 st — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is the rate of first shock		Average follow-up period is 530 days
Primary	The primary safety endpoint of this study is the rate of arrhythmic syncope		Average follow-up period is 530 days