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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

Tracking Information
First Submitted Date July 23, 2020
First Posted Date July 28, 2020
Last Update Posted Date May 12, 2021
Actual Study Start Date August 1, 2020
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 27, 2020)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
Official Title Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Heart Failure
Intervention Other: Observational
Observational only without any intervention
Study Groups/Cohorts 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.
Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 27, 2020)
2200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2027
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: PSR Study Team 1-800-633-8766 rs.productsurveillanceregistry@medtronic.com
Listed Location Countries France,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04489225
Other Study ID Numbers HFRS PAS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Medtronic
Study Sponsor Medtronic
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic
Verification Date May 2021