CRT Pilot Study for Children With Heart Failure

NCT00585065 | Completed FDA Device

• 1 other identifier: 00015291
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To collect information on pediatric patients receiving Cardiac Resynchronization Therapy (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart failure.

Conditions

Chronic Pediatric Heart Failure

Outcome Measures

Primary Outcomes (2)

• Collection of quality of life information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).

  Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always). Higher scores = Better health related quality of life (HRQOL)

  Within 30 days of CRT implant to 12 months post implant

• Collection of survival information using the Pediatric Quality of Life Inventory 4.0 (PedsQl v4.0) in children and adolescents with chronic, advanced heart failure (defined by NYHA Functional Classification).

  Composed of 23 items comprising 4 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always). Higher scores = Better health related quality of life (HRQOL)

  Within 30 days of CRT implant to 12 months post implant

Secondary Outcomes (1)

• Echocardiographic measurement predictors of positive response to cardiac resynchronization therapy (CRT) in children and adolescent patients according to the American Society of Echocardiography guidelines

  Within 30 days of CRT implant to 12 months post implant

Study Arms (1)

Pediatric and adolescent patients receiving CRT with BVP for treating chronic heart failure

Pediatric and adolescent patients who are receiving cardiac resynchronization therapy with biventricular pacing as a method of treating chronic heart failure. Children of both genders, who are followed in the Division of Pediatric Cardiology at Primary Children's Medical Center, who meet all inclusion and no exclusion criteria are eligible for participation in this clinical study. No intervention is administered as part of this study. Prospective longitudinal case series study to describe and evaluate clinical and hemodynamic effects of CRT and to identify echocardiographic predictors of positive response to CRT in Group described.

Device: CRT device implant

Interventions

CRT device implant DEVICE

The purpose of this study is to collect information on patients with chronic heart failure who have already been identified by their physician as candidates for CRT. All tests, including device implantation are standard of care for patients undergoing CRT. The only test involved in this study that is not standard of care is the quality of life questionnaire. Patients who undergo CRT system implant will be followed post-implant (up to 1 week), and at one month, three months, six months and twelve months. The only test involved in this study that is not standard of care is the quality of life questionnaire.

Pediatric and adolescent patients receiving CRT with BVP for treating chronic heart failure

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Chronic and severe heart failure, NYHA class III or IV
• Patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment
• Chronic systemic ventricular dysfunction as defined in the protocol.
• Intra ventricular conduction delay defined by spontaneous QRS duration \> ULN for age.
• All children from 1 to 18 years of age, both male and female, and all ethnic backgrounds.
• Signed and dated informed consent.
• Able to receive pectoral or abdominal implant.

You may not qualify if:

• Suspected acute myocarditis.
• Significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction.
• Acute coronary syndrome.
• Adolescents who are pregnant.
• Patient with BVP device implanted previously.
• Patient has had prior/past heart transplantation.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Officials

• Elizabeth Saarel, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 3, 2008
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2016
• Last Updated: May 11, 2023

Record last verified: 2021-04

Locations

US (1)