Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
PROVIDE
1 other identifier
observational
1,670
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2008
CompletedFirst Posted
Study publicly available on registry
August 29, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 4, 2019
February 1, 2019
3 years
August 28, 2008
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The primary endpoint of this study is the rate of first shock
Average follow-up period is 530 days
The primary safety endpoint of this study is the rate of arrhythmic syncope
Average follow-up period is 530 days
Study Arms (2)
Control
PROVE Trial settings
Experimental
Pre-selected settings
Interventions
Eligibility Criteria
Patients with approved ICD/CRT-D indications
You may qualify if:
- Primary Prevention indication for ICD/ CRT-D
You may not qualify if:
- No prior documented history of spontaneous VT/VF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hall-Garcia Cardiology Associates
Houston, Texas, 77598, United States
Related Publications (2)
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: 24112717RESULTSanders 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.
PMID: 29749945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammad Saeed, MD
Hall-Garcia Cardiology Associates
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2008
First Posted
August 29, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
February 4, 2019
Record last verified: 2019-02