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

NCT ID: NCT00758121

Last Updated: 2009-11-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-10-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation

Heart failure patients with an implanted CRT-D

Cardiac Resynchronization Therapy Defibrillator

Intervention Type: DEVICE

CRT-D observational study

Interventions

Cardiac Resynchronization Therapy Defibrillator

CRT-D observational study

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Boston Scientific CRM

Principal Investigators

Brian Jaski, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Cardiac Center

Pedro Brugada, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

San Diego Cardiac Center

San Diego, California, United States

UZ Brussel

Brussels, , Belgium

Countries

United States; Belgium

Other Identifiers

CR-CA-091008-H

Identifier Type: -

Identifier Source: org_study_id