The Product Surveillance Registry REVERSE Post Approval Study

Medtronic155 enrolled

Overview

The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.

The REVERSE PAS will estimate the 3-year survival probability of freedom from heart failure hospitalization and heart failure events in patients implanted with a Medtronic CRT-D device who meet the expanded indication criteria with a QRS duration ≤ 150 ms.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Heart Failure

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 Medtronic CRT-D who meets the expanded CRT-D indication criteria with a QRS ≤ 150ms * Patient within 30 days of implant Exclusion Criteria: * Patient who is, or will 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

Locations (123)

Outcomes

Primary Outcomes

Survival from Heart Failure Hospitalization and All-Cause Mortality

To estimate the 3-year survival probability of freedom from heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms.

Time frame: 3 years

Survival from Heart Failure Event and All-Cause Mortality

To estimate the 3-year survival probability of freedom from heart failure event or all- cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms.

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Chandler, Arizona, United States

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Gilbert, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Chula Vista, California, United States

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Los Angeles, California, United States

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Rancho Mirage, California, United States

...and 113 more locations