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

Heart Failure Clinical Trial

— CORRELATE-HF  

Official title:

CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00758121
• Other study ID #: CR-CA-091008-H
• Status: Terminated
• Phase: N/A
• First received: September 19, 2008
• Last updated: November 4, 2009
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2009
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEuropean Union: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy Defibrillator
CRT-D observational study

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels
United States	San Diego Cardiac Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,