CompletedNot Applicable

CRT Pilot Study for Children With Heart Failure

United States7 participantsStarted 2006-01

Plain-language 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.

Who can participate

Age range1 Year – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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).

Timeframe: 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).

Timeframe: Within 30 days of CRT implant to 12 months post implant

Trial details

NCT IDNCT00585065

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2008-01

View on ClinicalTrials.gov More Chronic Pediatric Heart Failure trials

Who can participate

Age range1 Year – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Timeframe: Within 30 days of CRT implant to 12 months post implant