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Trial record 2 of 3 for:    QUAD PAS

Personalized Therapy Study - Attain Stability Quad Post-Approval Study (ASQ)

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ClinicalTrials.gov Identifier: NCT04024943
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:
The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

Condition or disease Intervention/treatment
Heart Failure Device: Quadripolar LV Lead

Detailed Description:
The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are allowed.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : April 2027

Intervention Details:
  • Device: Quadripolar LV Lead
    The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is an active fixation quadripolar LV lead based on the Attain Performa lead family models (4298, 4398, and 4598). The lead incorporates an active fixation helix similar to the OUS commercialized Attain Stability bipolar LV lead (Model 20066/4796) which is designed to allow an implanter more options in lead location.
    Other Names:
    • Medtronic CRT-P
    • Medtronic CRT-D


Primary Outcome Measures :
  1. Percentage of patients without a lead- related event at 5 years post-implant [ Time Frame: 5 years ]
    To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads.


Secondary Outcome Measures :
  1. Number of lead-related adverse device effects [ Time Frame: 5 years ]

    The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product:

    • To summarize all Attain Stability Quad lead-related ADEs


  2. Number of explanted leads that have been returned [ Time Frame: 5 years ]

    The secondary objectives are descriptive in nature and are intended to gain additional information about the safety and performance of the Product:

    • To summarize analysis results from explanted and returned Attain Stability Quad leads




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population includes patients that are or will be implanted with a Model 4798 lead and a Medtronic CRT device.
Criteria

Inclusion Criteria:

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive or be treated with a Model 4798 lead and a Medtronic CRT device
  • Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria:

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

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): NCT04024943


Locations
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Sponsors and Collaborators
Medtronic
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT04024943    
Other Study ID Numbers: Attain Stability Quad PAS
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases