Correlation Of Respiratory Rate Level And Trend Evaluatio... | NCT00758121

Studies
Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients

NCT00758121

Sponsor

Boston Scientific Corporation

Status

Terminated

Last Update Posted

Nov 6, 2009Estimated

Enrollment

56Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy Defibrillator

Countries

United States
Belgium

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

Nov 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Sep 19, 2008

First Submission Date that Met QC Criteria

Sep 19, 2008

First Posted Date

Sep 23, 2008Estimated

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

Nov 4, 2009

Last Update Posted Date

Nov 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.

Detailed Description

The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.

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

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation		Heart failure patients with an implanted CRT-D	Device: Cardiac Resynchronization Therapy Defibrillator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Resynchronization Therapy Defibrillator	Device	CRT-D observational study	Observation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
Respiratory Sensor programmed "On"
Classified as having NYHA Class III heart failure documented, in the past 12 months
Age 18 or above, or of legal age to give informed consent specific to state and national law
Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol

Exclusion Criteria:

Inability or refusal to sign the patient Informed Consent
Inability or refusal to comply with the follow-up schedule
Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
Patients prescribed to positive airway pressure therapy
A life expectancy of less than 180 days, per physician discretion
Enrolled in any concurrent study without prior written approval from Boston Scientific CRM
Women who are pregnant or plan to become pregnant in the next twelve months

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

Heart failure patients with an implanted CRT-D.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Jaski, MD	San Diego Cardiac Center	Principal Investigator
Pedro Brugada, MD	Universitair Ziekenhuis Brussel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Diego Cardiac Center		San Diego	California	91213	United States
UZ Brussel

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases