Cardiac Rhythm and Heart Failure Product Surveillance Registry (PSR) Platform Base - Triage HF India
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- India Medtronic Pvt Ltd
- Enrollment
- 100
- Locations
- 11
- Primary Endpoint
- 1. All data collected from regional cohorts will contribute to the overall primary objective of safety and effectiveness of the product
Study Overview
Brief Summary
This is a non-randomized, prospective and non-regulated study on commercial released TraigeHF which is enabled with Cobalt/Crome device. The main objective of study is to collect data from regional cohorts and assess the overall primary objective of safety and effectiveness of the commercialized product.
Study will be conducted in 10-12 sites in India with a target to enroll 100 patients. Study duration will be 2-3 years which include 12 months follow up.
Data will be collected at Baseline (consenting, eligibility, pre-procedure and Medical history), CVG procedure (Procedure type and implant) and follow-up visits.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
- •Patient has, or is intended to receive or be treated with, an eligible Medtronic product
- •Patient is consented within the enrollment window of the therapy received, as applicable
- •Additional Therapy-specific components if needed.
Exclusion Criteria
- •Patient who is, or is expected to be, inaccessible for follow-up
- •Participation is excluded by local law
- •Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
- •Additional Therapy-specific components if needed.
Outcomes
Primary Outcomes
1. All data collected from regional cohorts will contribute to the overall primary objective of safety and effectiveness of the product
Time Frame: Baseline, Implant/ Procedure, 12 months follow up
2. The primary effectiveness objective is to estimate the positive predictive value (PPV) of HFRS high risk status associated with worsening heart failure.
Time Frame: Baseline, Implant/ Procedure, 12 months follow up
Secondary Outcomes
- 1. Summarize the number of subsequent heart failure hospitalization (HFH) or HF related deaths that were not preceded by a high Heart Failure Risk Status.(2. Compare the incidence in subsequent heart failure hospitalization between subjects with actions taken based on HFRS and subjects without actions taken.)
Investigators
Vinay Rajan
India Medtronic Pvt Ltd