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Quadripolar Pacing Post Approval Study (Quad PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01555619
First received: March 13, 2012
Last updated: June 20, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Heart Failure Device: CRT-D System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quadripolar Pacing Post Approval Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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


Enrollment: 1971
Study Start Date: February 15, 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CRT-D System
St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.
Device: CRT-D System
Implantation of a CRT-D System
Other Name: CRT-D and LV pacing lead

Detailed Description:
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 Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so.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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for cardiac resynchronization therapy.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555619

  Show 71 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Raffaele Corbisiero, MD Deborah Heart and Lung Center
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01555619     History of Changes
Other Study ID Numbers: 60030283
Study First Received: March 13, 2012
Last Updated: June 20, 2017
Individual Participant Data  
Plan to Share IPD: 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

Keywords provided by St. Jude Medical:
Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart Failure
Quadripolar pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017