Personalized CRT - PSR | NCT03723265

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Apr 28, 2022Actual

Completion Date

Apr 28, 2022Actual

First Submitted Date

Oct 15, 2018

First Submission Date that Met QC Criteria

Oct 26, 2018

First Posted Date

Oct 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2022

Last Update Posted Date

May 20, 2022Actual

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,517Actual

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Resynchronization Therapy	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Treatment effects for different CRT features in the CRT non-responder population

Other Outcomes

Not provided

Eligibility Module

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 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population includes patients that are or will be implanted with an eligible CRT system.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D002304	Cardiac Pacing, Artificial
D004599	Electric Stimulation Therapy
D013812	Therapeutics