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Quadripolar Pacing Post Approval Study (Quad PAS)

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.
 
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

Study Description
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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).

Condition or disease Intervention/treatment
Heart Failure Device: CRT-D System

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 Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so.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 Design
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Study Type : Observational
Actual Enrollment : 1971 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quadripolar Pacing Post Approval Study
Actual Study Start Date : February 15, 2012
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Mean programmed LV lead pacing capture threshold [ Time Frame: 5 years ]
    Mean programmed LV lead pacing capture threshold at 5 years


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients indicated for CRT.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555619


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Raffaele Corbisiero, MD Deborah Heart and Lung Center
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01555619    
Other Study ID Numbers: 60030283
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart Failure
Quadripolar pacing
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases