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Personalized Therapy Study - HFRS (TriageHF) Post Approval Study

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ClinicalTrials.gov Identifier: NCT04489225
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:
Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Condition or disease Intervention/treatment
Heart Failure Other: Observational

Detailed Description:
The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will be followed per the standard of care practices of their care provider.

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Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Observational
This single arm observational study includes all patients implanted with a Medtronic Cobalt™ XT ICD or CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry (PSR). Patients will be followed per the standard of care practices of their care provider. All patients must provide a signed informed consent.
Other: Observational
Observational only without any intervention




Primary Outcome Measures :
  1. positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure [ Time Frame: Up to 5 years ]
    To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure


Secondary Outcome Measures :
  1. Number of HF hospitalization or HF related deaths [ Time Frame: Up to 5 years ]
    Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes all patients implanted with a Medtronic Cobalt™ XT ICD or CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry (PSR).
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 an eligible ICD or CRT device or Patients may be enrolled pre-implant and up to 30 days post-implant following confirmation of patient eligibility.
  • Patient is enrolled in the Medtronic CareLink® Network for remote monitoring.

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): NCT04489225


Contacts
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Contact: PSR Study Team 1-800-633-8766 rs.productsurveillanceregistry@medtronic.com

Locations
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Sponsors and Collaborators
Medtronic
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT04489225    
Other Study ID Numbers: HFRS PAS
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases