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:
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

March 13, 2012
February 26, 2014
February 2012
August 2019   (final data collection date for primary outcome measure)
  • •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 ]
Same as current
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients indicated for cardiac resynchronization therapy.

Heart Failure
Device: Implantation of a 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: Implantation of a 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
1884
April 2020
August 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01555619
60030283
No
St. Jude Medical
St. Jude Medical
Not Provided
Study Chair: Raffaele Corbisiero, MD Deborah Heart and Lung Center
St. Jude Medical
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP