tunneled pleural catheter for Congestive Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Congestive Heart Failure+2 Moretunneled pleural catheter - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether a tunneled pleural catheter (TPC) can improve quality of life for people with congestive heart failure (CHF) who have recurrent symptomatic pleural effusions that are not helped by diuretics.

Eligible Conditions
  • Congestive Heart Failure
  • Shortness of Breath
  • Chronic Pleural Effusions

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 1 year post-enrollment

1 year post-enrollment
All cause mortality
Incidence of hemothorax
Incidence of hospitalizations and emergency room encounters
Incidence of pleural procedures
Incidence of pleural space or chest wall infection
Incidence of pleurodesis
Incidence of trapped lung, loculated pleural effusion, and pneumothorax
Rate of hemodialysis initiation
Time to pleurodesis among those who achieved pleurodesis
Month 12
Change from baseline serum albumin
Change from baseline serum creatinine
Change in quality of life scores from baseline as measured by the Minnesota Living with Heart Failure Questionnaire
New York Heath Association (NYHA) functional class

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Intervention Group
1 of 2

Active Control

Experimental Treatment

210 Total Participants · 2 Treatment Groups

Primary Treatment: tunneled pleural catheter · No Placebo Group · N/A

Intervention Group
Device
Experimental Group · 1 Intervention: tunneled pleural catheter · Intervention Types: Device
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post-enrollment

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,411 Previous Clinical Trials
6,941,379 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had two or more episodes of pleural effusions
The pleural fluid is clinically determined to be due only to CHF.
The patient has a documented subjective symptom relief after thoracentesis and drainage of the pleural space.
References