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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00743522
First received: August 28, 2008
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  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: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Programming Implantable Cardioverter Defibrillators (ICDs) in Patients With Primary Prevention Indication to Prolong Time to First Shock

Resource links provided by NLM:

U.S. FDA Resources

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: Study Termination ] [ Designated as safety issue: No ]
  • The primary safety endpoint of this study is the rate of arrhythmic syncope [ Time Frame: Study Termination ] [ Designated as safety issue: Yes ]

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)
Arms Assigned Interventions
Active Comparator: Control
PROVE Trial settings
 Device: ICD/ CRT-D
Cardiac device
Experimental: Experimental
Pre-selected settings
 Device: ICD/ CRT-D
Cardiac device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary Prevention indication for ICD/ CRT-D

Exclusion Criteria:

  • No prior documented history of spontaneous VT/VF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00743522     History of Changes
Other Study ID Numbers: 448
Study First Received: August 28, 2008
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
Reducing shocks

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013