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Trial record 1 of 1 for:    Quadripolar Pacing Post Approval Study
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Quadripolar Pacing Post Approval Study (Quad PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01555619
First Posted: March 15, 2012
Last Update Posted: June 22, 2017
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
March 13, 2012
March 15, 2012
June 22, 2017
February 15, 2012
March 2019   (Final data collection date for primary outcome measure)
  • Complication free survival rate related to the CRT-D system [ Time Frame: 5 years ]
    Complication free survival rate through 5 years for complications related to the CRT-D system
  • Complication free survival rate related to the LV lead [ Time Frame: 5 years ]
    Complication free survival rate at 5 years for complications related to the left ventricular lead
  • Mean programmed LV lead pacing capture threshold [ Time Frame: 5 years ]
    Mean programmed LV lead pacing capture threshold at 5 years
  • •Complication free survival rate through 5 years for complications related to the CRT-D system [ Time Frame: 5 years ]
  • •Complication free survival rate at 5 years for complications related to the left ventricular lead [ Time Frame: 5 years ]
  • Mean programmed LV lead pacing capture threshold at 5 years [ Time Frame: 5 years ]
Complete list of historical versions of study NCT01555619 on ClinicalTrials.gov Archive Site
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Quadripolar Pacing Post Approval Study
Quadripolar Pacing Post Approval Study
The purpose of this post approval study is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy.
The Quadripolar Pacing Post Approval Study is a multi-center, post-approval study. Patients who meet inclusion/exclusion criteria will have an attempted implant of a Quadripolar CRT-D device system (device and lead). Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so. Patients enrolled in the study will be followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years). After patients complete 60 months of follow-up, their participation in the study will be terminated.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients indicated for cardiac resynchronization therapy.
Heart Failure
Device: CRT-D System
Implantation of a CRT-D System
Other Name: CRT-D and LV pacing lead
CRT-D System
St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.
Intervention: Device: CRT-D System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1971
December 2019
March 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Approved indication per current ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s).
  2. Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study (IDE study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
  3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
  2. Have a life expectancy of less than 5 years due to any condition
  3. Be less than 18 years of age
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01555619
60030283
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: No
St. Jude Medical
St. Jude Medical
Not Provided
Study Chair: Raffaele Corbisiero, MD Deborah Heart and Lung Center
St. Jude Medical
June 2017