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Quadripolar Pacing Post Approval Study (Quad PAS)

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ClinicalTrials.gov Identifier: NCT01555619
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date March 13, 2012
First Posted Date March 15, 2012
Last Update Posted Date April 16, 2019
Actual Study Start Date February 15, 2012
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2018)
  • 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 LV lead
  • Mean programmed LV lead pacing capture threshold [ Time Frame: 5 years ]
    Mean programmed LV lead pacing capture threshold at 5 years
Original Primary Outcome Measures
 (submitted: March 14, 2012)
  • •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 ]
Change History Complete list of historical versions of study NCT01555619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quadripolar Pacing Post Approval Study
Official Title Quadripolar Pacing Post Approval Study
Brief Summary 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 (CRT).
Detailed Description Quad PAS 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 left ventricular (LV) 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients indicated for CRT.
Condition Heart Failure
Intervention Device: CRT-D System
Implantation of a CRT-D System
Other Name: CRT-D and LV pacing lead
Study Groups/Cohorts CRT-D System
St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.
Intervention: Device: CRT-D System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2015)
1971
Original Estimated Enrollment
 (submitted: March 14, 2012)
1884
Actual Study Completion Date February 28, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Approved indication per current American College of Cardiology/American Heart Association/Heart Rhythm Society 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 (Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing implantable cardioverter-defibrillator 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01555619
Other Study ID Numbers 60030283
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Chair: Raffaele Corbisiero, MD Deborah Heart and Lung Center
PRS Account Abbott Medical Devices
Verification Date April 2019