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: February 26, 2014
Last verified: February 2014
  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: Implantation of a CRT-D System

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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • •Complication free survival rate through 5 years for complications related to the CRT-D system [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • •Complication free survival rate at 5 years for complications related to the left ventricular lead [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Mean programmed LV lead pacing capture threshold at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1884
Study Start Date: February 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: August 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: Implantation of a CRT-D System
Implantation of a CRT-D System
Other Name: CRT-D and LV pacing lead

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555619

  Show 72 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Raffaele Corbisiero, MD Deborah Heart and Lung Center
  More Information

No publications provided

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: February 26, 2014
Health Authority: United States: Institutional Review Board

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 April 23, 2014