The Product Surveillance Registry REVERSE Post Approval Study

Heart Failure Clinical Trial

— PSR-REVERSE  

Official title:

The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660035
• Other study ID #: PSR-REVERSE
• Status: Completed
• Start date: April 2012
• Est. completion date: April 2022

Study information

• Verified date: April 2022
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Hattiesburg Clinic	Hattiesburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Primary	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.	3 years