Personalized CRT - PSR

Heart Failure Clinical Trial

Official title:

Personalized CRT - Product Surveillance Registry (PSR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723265
• Other study ID #: Personalized CRT
• Status: Completed
• Start date: January 2012
• Est. completion date: April 28, 2022

Study information

• Verified date: May 2022
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

Description:

The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1517
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• 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 an eligible CRT device
• Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Malaysia,  Netherlands,  Serbia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRT Response	A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits.	Every 3-9 months
Secondary	Treatments for CRT non-response	Summary statistics will be obtained to describe the distribution of different treatments (or no treatment) the patient receives.	Every 3-9 months
Secondary	Treatment effects for different CRT features in the CRT non-responder population	A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response.	Every 3-9 months
Secondary	Patient outcome post initial CRT implant	Patient outcome will be measured as the patient first occurrence of HF related hospitalization or death.	Every 3-9 months