Adult Congenital Heart Disease Registry (QuERI)



Status:Completed
Conditions:High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:December 1, 2011
End Date:May 16, 2018

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Adult Congenital Heart Disease Quality Enhancement Research Initiative

Multi-center, observational, U.S.-based longitudinal program. Data will be collected
prospectively for 3 years. Individual physician feedback will be provided on data collected
with the purpose of improving the management of patients - quality enhancement research
initiative (QuERI) process from adult patients enrolled with a history of repaired Congenital
Heart Disease (CHD).

Approximately 800 male and female adult patients with a history of repaired CHD will be
recruited from approximately 100 cardiology practices and will be followed up every twelve
months for the period of three years. Consecutive patients in each practice meeting inclusion
and exclusion criteria should be considered for the study. Two groups of subjects will be
enrolled based on identical exclusion criteria and inclusion criteria, with the exception
only of inclusion criteria #3: cohort 1- those demonstrating historic high risk criteria and
cohort 2 - those demonstrating current high risk criteria.

Inclusion Criteria: Cohort 1 (historic high risk)

1. Male and female adults (≥ 18 years of age)

2. Patients with documented history (at least one year) of an isolated, repaired
congenital heart defect such as ASD, VSD, PDA, AVC (AVSD)

3. History of a large defect prior to closure as evidenced by any one of the following:

- Size of: ASD > 2 cm; VSD > 1 cm; PDA > 0.6 cm

- Shunt 2:1 or greater

- Pre-operative PH (PAS > 40 mmHg) or documented shunt- related heart failure
(radiographic evidence)

- Pre-operative atrial fibrillation or flutter

4. High risk features (any one the following):

- Age > 40 years

- Later surgical repair:

i. ≥ 2 years of age for PDA or VSD ii. ≥ 1 year of age for AVC iii. ≥ 10 years of
age for ASD

- Sinus venosus defect

- Primum defect

- WHO functional class > 1

- Atrial fibrillation or flutter

5. Echocardiographic evidence of high risk features. Any one of the following:

- Degree of TR that is mild or greater

- Right ventricular (RV) systolic dysfunction

- Evidence of RV dilatation: Any one of the following:

i. Evidence of RV dilation by general, qualitative assessment ii. RV end
diastolic diameter > 3.2 cm on apical 4 chamber view at the tips of the tricuspid
valve iii. RV to LV ratio at end-diastole > 0.6 (RV and LV end diastolic
dimensions measured from apical 4 chamber view, 1 cm apical of the respective
valve annuli)

- Any abnormality in the motion of the inter-ventricular septum

6. Ability and desire to execute the consent for follow up

Inclusion Criteria: Cohort 2 (current high risk)

1. Male and female adults (≥ 18 years of age)

2. Patients with documented history (at least one year) of an isolated, repaired
congenital heart defect such as ASD, VSD, PDA, AVC (AVSD)

3. Current (within the last 12 months) evidence of 1 or more of the 7 following criteria:

- Desaturation on exercise (92% or less)

- 6 MWD <380 m

- PFT demonstrating DLC <70% predicted & FEV1>70% predicted

- ECG demonstrating i) RAD and ii) RVH or RAE

- Physical findings of edema accompanied by elevated JVP and +HJR

- CXR evidence of enlarged main and/or hilar pulmonary arterial shadows in
association with right ventricular enlargement

- Elevated biomarks (BNP or NT-proBNP above upper limit of normal)

4. High risk features (any one of the following:)

- Age > 40 years

- Later surgical repair:

i. ≥ 2 years of age for PDA or VSD ii. ≥ 1 year of age for AVC iii. ≥ 10 years of
age for ASD

- Sinus venosus defect

- Primum defect

- WHO functional class > 1

- Atrial fibrillation or flutter

5. Echocardiographic evidence of high risk features. Any one of the following:

- Degree of TR that is mild or greater

- Right ventricular (RV) systolic dysfunction

- Evidence of RV dilatation: Any one of the following:

i. Evidence of RV dilation by general, qualitative assessment ii. RV end
diastolic diameter > 3.2 cm on apical 4 chamber view at the tips of the tricuspid
valve iii. RV to LV ratio at end-diastole > 0.6 (RV and LV end diastolic
dimensions measured from apical 4 chamber view, 1 cm apical of the respective
valve annuli)

- Any abnormality in the motion of the inter-ventricular septum

6. Ability and desire to execute the consent for follow up

Exclusion Criteria:

1. Poor mental function, drug or substance (e.g., alcohol) abuse, or unstable psychiatric
illness, which, in the opinion of the investigator, may interfere with optimal
participation in the study

2. Diagnosis of PAH (defined as RHC demonstrating mPAP ≥ 25 mm Hg and PCWP ≤ 15 and PVR >
3 WU or PVR (indexed) > 4 WU or treatment with PAH specific therapy) after surgical
repair and prior to visit 1

3. Prior inclusion in this registry
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Albany, NY
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1930
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Ann Arbor, MI
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Asheville, North Carolina 28802
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Asheville, NC
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
825
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Aurora, CO
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Boston, MA
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Brandon, Florida 33511
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Charlottesville, Virginia 22908
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Cincinnati, OH
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Columbus, OH
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Cooperstown, NY
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Doylestown, Pennsylvania 18901
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Gainesville, Florida 32608
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Hershey, PA
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Hollywood, Florida 33021
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Honolulu, Hawaii 96813
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Houston, TX
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Kansas City, Kansas 66160
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Las Vegas, Nevada 89109
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Morgantown, West Virginia 26506
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New Hyde Park, New York 11040
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Oak Lawn, Illinois 60453
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Oakland, California 94609
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Palo Alto, California 94304
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3401 N Broad St
Philadelphia, Pennsylvania
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