Condition

Congenital heart anomalies

Clinical trials and treatment information for Congenital heart anomalies

15.8M
People Affected
150
Active Trials
1.6M
New Cases/Year
251K
Deaths/Year

Treatment Rankings

Ranked by evidence volume first. Medicine has spent centuries ranking things by vibes. This is an improvement.

1
Catheter-based Atrial Septal Defect (ASD) Closure
98% Effectiveness• 98% Confidence• 60% Safety• 1 trials• 80K participants
HIGH EvidenceExcellent Value
Find Trials

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
60
DangerousModerateSafe

Time to Effect

Immediate (shunt closure), recovery over days-weeks

Duration

Single procedure, long-term monitoring

Response Rate

98%

Remission Rate

95%

Common Side Effects:

Device embolization/malposition: 1%
Perforation/tamponade: 0.5%
Arrhythmias (transient): 5%
Groin hematoma/vascular injury: 5%
Residual shunt: 2%
Device erosion: 0.1%

Annual Cost of Care

Drug Cost

$50

Monitoring

$500

Side Effects

$50

Total Annual

$600

Cost-Effectiveness

EXCELLENT

QALYs Gained

12

ICER

$30,000/QALY

Cost per Remission

$631.58

Cost per Responder

$612.24

Treatment Outcomes
Primary Outcomes
Qp/Qs Ratio (Left-to-Right Shunt)2.0
-50% (-1.0)
Right Ventricular End-Diastolic Volume Index (RVEDVI)120 mL/m^2
-25% (-30 mL/m^2)
6-Minute Walk Distance (6MWD)300 meters
+33.3% (+100 meters)
Mean Pulmonary Artery Pressure (mPAP)35 mmHg
-28.6% (-10 mmHg)
Secondary Benefits
SF-36 Physical Component Summary (PCS) Score40 points
+20% (+8 points)
Right Atrial Volume Index (RAVI)50 mL/m^2
-30% (-15 mL/m^2)
Brain Natriuretic Peptide (BNP)150 pg/mL
-50% (-75 pg/mL)
Common Side Effects
Device embolization/malposition
+1%
Perforation/tamponade
+0.5%
Arrhythmias (transient)
+5%

Clinical Trial Phases:

Phase 4
2
Prostaglandin E1 (Alprostadil) Infusion
98% Effectiveness• 99% Confidence• 40% Safety• 1 trials• 10K participants
HIGH EvidenceExcellent ValueDose: 0.05-0.1 mcg/kg/min continuous IV infusion
Find Trials

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
40
DangerousModerateSafe

Time to Effect

Minutes to hours

Duration

Hours to days (until surgical/catheter intervention)

Response Rate

98%

Remission Rate

%

Number Needed to Treat (NNT)

1

Common Side Effects:

Apnea: 10%
Fever: 10%
Hypotension: 5%
Flushing: 5%
Bradycardia: 2%
Seizures: 1%
Edema: 5%

Annual Cost of Care

Drug Cost

$5,000

Monitoring

$10,000

Side Effects

$1,000

Total Annual

$16,000

Cost-Effectiveness

EXCELLENT

QALYs Gained

0.5

ICER

$5,000/QALY

Cost per Responder

$16,326.53

Treatment Outcomes
Primary Outcomes
Arterial Oxygen Saturation (SpO2)55-70%
+25% (+15 percentage points)
Mean Arterial Pressure (MAP)30-40 mmHg
+30% (+10 mmHg)
Partial Pressure of Oxygen (PaO2)25-35 mmHg
+70% (+20 mmHg)
Blood pH7.18
+2.1% (+0.15 pH units)
Secondary Benefits
Serum Lactate5.5 mmol/L
-40% (-2.2 mmol/L)
Urine Output0.3 mL/kg/hr
+200% (+0.6 mL/kg/hr)
Capillary Refill Time4 seconds
-50% (-2 seconds)
Common Side Effects
Apnea
+10%
Fever
+10%
Hypotension
+5%

Clinical Trial Phases:

Phase 4
3
Surgical Ventricular Septal Defect (VSD) Repair
95% Effectiveness• 95% Confidence• 50% Safety• 4 trials• 150K participants
HIGH EvidenceExcellent Value
Find Trials

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
50
DangerousModerateSafe

Time to Effect

Immediate (hemodynamic improvement), full recovery over weeks-months

Duration

Single procedure, lifetime monitoring

Response Rate

95%

Remission Rate

90%

Common Side Effects:

Arrhythmias (e.g., heart block): 3%
Residual VSD: 3%
Pleural/pericardial effusion: 7%
Infection: 2%
Bleeding requiring reoperation: 1%
Stroke: 0.5%
Mortality: 1%

Annual Cost of Care

Drug Cost

$100

Monitoring

$750

Side Effects

$100

Total Annual

$950

Cost-Effectiveness

EXCELLENT

QALYs Gained

15

ICER

$25,000/QALY

Cost per Remission

$1,055.56

Cost per Responder

$1,000

Treatment Outcomes
Primary Outcomes
Left-to-Right Shunt Qp:Qs Ratio2.5:1
-60% (Reduction from 2.5:1 to 1.0:1)
Pulmonary Artery Systolic Pressure45 mmHg
-44.4% (-20 mmHg)
Ross Heart Failure Score8 points (out of 12)
-75% (-6 points)
Secondary Benefits
Weight-for-Age Z-score-2.0 SD
+75% (+1.5 SD)
Peak Oxygen Consumption (VO2 max) % predicted60% of predicted
+50% (+30% of predicted)
Hospitalizations for Respiratory Infections per Year3 hospitalizations/year
-83.3% (-2.5 hospitalizations/year)
Common Side Effects
Arrhythmias (e.g., heart block)
+3%
Residual VSD
+3%
Pleural/pericardial effusion
+7%

Clinical Trial Phases:

Phase 4
4
Arterial Switch Operation (ASO) for Transposition of Great Arteries (TGA)
95% Effectiveness• 98% Confidence• 45% Safety• 1 trials• 50K participants
HIGH EvidenceExcellent Value
Find Trials

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
45
DangerousModerateSafe

Time to Effect

Immediate (hemodynamic correction), critical early recovery, long-term monitoring

Duration

Single procedure (neonatal), lifetime specialized cardiac care

Response Rate

95%

Remission Rate

90%

Common Side Effects:

Coronary artery stenosis: 5%
Supravalvular pulmonary stenosis: 10%
Neoaortic root dilation/regurgitation: 15%
Arrhythmias: 5%
Mortality: 3%

Annual Cost of Care

Drug Cost

$200

Monitoring

$1,500

Side Effects

$400

Total Annual

$2,100

Cost-Effectiveness

EXCELLENT

QALYs Gained

25

ICER

$40,000/QALY

Cost per Remission

$2,333.33

Cost per Responder

$2,210.53

Treatment Outcomes
Primary Outcomes
Arterial Oxygen Saturation75-85%
+22.5% (+15-20 percentage points (to >95%))
Right Ventricular Systolic Pressure (RVSP)Systemic pressure (e.g., 70-90 mmHg)
-70% (-50-60 mmHg (to pulmonary levels, e.g., <30 mmHg))
B-type Natriuretic Peptide (BNP)200-500 pg/mL
-60% (-240 pg/mL (towards age-appropriate normal))
Cardiothoracic Ratio0.60-0.65 (cardiomegaly)
-20% (-0.12 (towards normal <0.55))
Secondary Benefits
VO2 Max60-70% of predicted (for age-appropriate patients)
+30.7% (+15-20 percentage points of predicted VO2 max)
Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score50/100 (significant impairment)
+40% (+20 points (towards higher quality of life))
Weight Gain Velocity10-15 g/day (suboptimal for age, e.g., 3-month-old infant)
+50% (+6 g/day (towards age-appropriate growth rate))
Common Side Effects
Coronary artery stenosis
+5%
Supravalvular pulmonary stenosis
+10%
Neoaortic root dilation/regurgitation
+15%

Clinical Trial Phases:

Phase 4
5
Surgical Coarctation of Aorta Repair
95% Effectiveness• 95% Confidence• 50% Safety• 4 trials• 50K participants
HIGH EvidenceExcellent Value
Find Trials

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
50
DangerousModerateSafe

Time to Effect

Immediate (pressure gradient relieved), blood pressure normalization over days-weeks

Duration

Single procedure, lifetime monitoring (especially for hypertension)

Response Rate

95%

Remission Rate

90%

Common Side Effects:

Recurrent coarctation: 5%
Paradoxical hypertension: 10%
Spinal cord ischemia/paraplegia: 0.1%
Chylothorax: 2%
Nerve injury (recurrent laryngeal, phrenic): 2%
Mortality: 1%

Annual Cost of Care

Drug Cost

$100

Monitoring

$750

Side Effects

$100

Total Annual

$950

Cost-Effectiveness

EXCELLENT

QALYs Gained

15

ICER

$30,000/QALY

Cost per Remission

$1,055.56

Cost per Responder

$1,000

Treatment Outcomes
Primary Outcomes
Upper Extremity Systolic Blood Pressure155 mmHg
-22.6% (-35 mmHg)
Peak Systolic Pressure Gradient across Coarctation (Doppler)50 mmHg
-90% (-45 mmHg)
Left Ventricular Mass Index (LVMI)110 g/m^2
-13.6% (-15 g/m^2)
Secondary Benefits
Upper-to-Lower Extremity Systolic Blood Pressure Gradient45 mmHg
-88.9% (-40 mmHg)
Maximal Workload (Cardiopulmonary Exercise Testing)120 Watts
+20.8% (+25 Watts)
Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score70/100
+17.1% (+12 points)
Common Side Effects
Recurrent coarctation
+5%
Paradoxical hypertension
+10%
Spinal cord ischemia/paraplegia
+0.1%

Clinical Trial Phases:

Phase 4
6
Surgical Tetralogy of Fallot (TOF) Repair
90% Effectiveness• 95% Confidence• 48% Safety• 10 trials• 100K participants
HIGH EvidenceExcellent Value
Find Trials

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
48
DangerousModerateSafe

Time to Effect

Immediate (defect correction), full recovery over weeks-months, long-term monitoring

Duration

Single procedure, lifetime specialized cardiac care

Response Rate

90%

Remission Rate

85%

Common Side Effects:

Pulmonary regurgitation: 20%
Residual VSD/outflow tract obstruction: 5%
Arrhythmias: 5%
Infection: 2%
Bleeding: 1%
Mortality: 2%

Annual Cost of Care

Drug Cost

$200

Monitoring

$1,200

Side Effects

$300

Total Annual

$1,700

Cost-Effectiveness

EXCELLENT

QALYs Gained

18

ICER

$35,000/QALY

Cost per Remission

$2,000

Cost per Responder

$1,888.89

Treatment Outcomes
Primary Outcomes
Peripheral Oxygen Saturation75% (pre-repair)
+20% (+15 percentage points)
Right Ventricular Outflow Tract Peak Gradient70 mmHg (pre-repair)
-85.7% (-60 mmHg)
Right Ventricular / Systemic Pressure Ratio0.80 (pre-repair)
-75% (-0.60)
Peak Oxygen Consumption (Peak VO2) during exercise60% of predicted for age/sex (pre-repair)
+33.3% (+20% of predicted)
Secondary Benefits
Pediatric Quality of Life Inventory (PedsQL) Cardiac Module Score50/100 (pre-repair)
+40% (+20 points)
Percentage of Ideal Body Weight80% (pre-repair)
+18.75% (+15 percentage points of ideal body weight)
Ross Functional Class3 (pre-repair, on a 1-4 scale)
-50% (-1.5 classes)
Common Side Effects
Pulmonary regurgitation
+20%
Residual VSD/outflow tract obstruction
+5%
Arrhythmias
+5%

Clinical Trial Phases:

Phase 4
7
Fontan Procedure
80% Effectiveness• 90% Confidence• 45% Safety• 58 trials• 30K participants
HIGH EvidenceGood Value
Find Trials

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
45
DangerousModerateSafe

Time to Effect

Immediate (hemodynamic change), staged over months to years, long-term management

Duration

Staged procedures over years, lifetime specialized cardiac and multi-organ care

Response Rate

85%

Remission Rate

30%

Common Side Effects:

Protein-losing enteropathy: 10%
Plastic bronchitis: 5%
Arrhythmias: 20%
Liver dysfunction/cirrhosis: 15%
Thromboembolism: 10%
Heart failure/Fontan failure: 15%
Mortality: 5%

Annual Cost of Care

Drug Cost

$500

Monitoring

$2,000

Side Effects

$1,500

Total Annual

$4,000

Cost-Effectiveness

GOOD

QALYs Gained

10

ICER

$60,000/QALY

Cost per Remission

$13,333.33

Cost per Responder

$4,705.88

Treatment Outcomes
Primary Outcomes
Oxygen Saturation (SpO2)80-85%
+14.7% (+12%)
Ross Classification (functional class)Ross Class III (score 3)
-66.7% (-2 classes (e.g., from III to I))
6-Minute Walk Test (6MWT) Distance300 meters
+50% (+150 meters)
Mean Fontan Circuit Pressure15 mmHg
-20% (-3 mmHg)
Secondary Benefits
PedsQL Cardiac Module Score (Quality of Life)60/100
+33.3% (+20 points)
Systemic Ventricular Ejection Fraction (SVEF)50%
+10% (+5 percentage points)
Hospitalization days per year for cardiac causes15 days/year
-66.7% (-10 days/year)
Common Side Effects
Protein-losing enteropathy
+10%
Plastic bronchitis
+5%
Arrhythmias
+20%

Clinical Trial Phases:

Phase 4