Risk Stratification and Benefits With Cardiac Resynchroni... | NCT00996086

Studies
Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

NCT00996086

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

154Actual

Phase

Not provided

Conditions

Heart Failure
Ventricular Arrhythmias

Interventions

CRT device implant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

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

Feb 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

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

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Name	Class
Northwestern University	OTHER
VA Pittsburgh Healthcare System	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.

Detailed Description

The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.

This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

154Actual

Label	Type	Description	Intervention Names
CRT device-recipients			Device: CRT device implant

Name	Type	Description	Arm Group Labels	Other Names
CRT device implant	Device	CRT device-recipients	CRT device-recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in 6-minute hall walk distance between baseline and subsequent follow-up		12 months
Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36)		12 months
The occurrence of either death (all-cause) or first HF hospitalization.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life		12 months
Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets current clinical indications for CRT-D therapy
Patient is 18 years old or older
Ability to independently comprehend and complete all QOL questionnaires
Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up

Exclusion Criteria:

Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
Myocardial infarction in the last 3 weeks
Unstable angina in the last 3 weeks
Status 1 classification for cardiac transplantation
Currently participating in a clinical trial that includes an active treatment arm
Life expectancy of less than 12 months.
Recent (within 1 week) administration of Nesiritide™ or inotropes
Patients in whom revascularization is expected
Patient is pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who undergo implantation of a market-approved St. Jude Medical CRT defibrillator (CRT-D) and a compatible lead system may be included in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Kadish, M.D.	Northwestern University	Principal Investigator
Alaa Shalaby, M.D.	VA Pittsburgh Healthcare System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Touro College		New York	New York	10010	United States
Veterans' Adminstration Pittsburgh Healthcare System

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases