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Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication (PROVIDE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743522
First Posted: August 29, 2008
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  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.

Condition Intervention Phase
Shock Device: ICD/ CRT-D Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Programming Implantable Cardioverter Defibrillators (ICDs) in Patients With Primary Prevention Indication to Prolong Time to First Shock

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The primary endpoint of this study is the rate of first shock [ Time Frame: Average follow-up period is 530 days ]
  • The primary safety endpoint of this study is the rate of arrhythmic syncope [ Time Frame: Average follow-up period is 530 days ]

Enrollment: 1670
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control
PROVE Trial settings
Device: ICD/ CRT-D
Cardiac device
Experimental
Pre-selected settings
Device: ICD/ CRT-D
Cardiac device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with approved ICD/CRT-D indications
Criteria

Inclusion Criteria:

  • Primary Prevention indication for ICD/ CRT-D

Exclusion Criteria:

  • No prior documented history of spontaneous VT/VF
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743522


Locations
United States, Texas
Hall-Garcia Cardiology Associates
Houston, Texas, United States, 77598
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Mohammad Saeed, MD Hall-Garcia Cardiology Associates
  More Information

Publications:
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00743522     History of Changes
Other Study ID Numbers: 448
First Submitted: August 28, 2008
First Posted: August 29, 2008
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by St. Jude Medical:
Reducing shocks

Additional relevant MeSH terms:
Shock
Pathologic Processes