Phase 2
N=29
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Congenital Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT01063712 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment) — 19; 23; 28; 29 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nit-Occlud® PDA-R (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- pfm S.R.L.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment) |
19; 23; 28; 29; 29; 29 | <0.01 sig |
| SECONDARY Number of Patients With a Decreased Dilation of the Left Heart Chamber (Time Frame: One Year After Treatment). Dilation of the Left Ventricle and Left Atrium Was Measured Before and One Year After Implantation by Echocardiography. |
29; 29 | <0.01 sig |
Summary
The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.
Eligibility Criteria
Inclusion Criteria
- Clinical and echocardiographic compatibility with PDA without associated heart disease requiring surgical solution
- Minimum diameter of the PDA 2 to 8 mm
- Systolic pulmonary pressure measured during cardiac catheterization, not on pass 2/3 of the values of the systolic systemic pressure
- Weight higher than 10 kg, regardless of age
- Patients who were diagnosed and recruited during the period 2009 - 2010
- Patients with trisomy 21 also fulfill the previous criteria, the number of patients with T21 will not exceed 10% of the entire group of patients.
- letter of consent signed by parents or legal guardian
Relative Exclusion Criteria:
- Infections that occur during acute bacteremia, viremia, which can be treated
- Febrile syndrome
- Tooth decay
- Once the acute solved considering the patient's inclusion into the study
Exclusion Criteria
- Pregnant women
- Pulmonary hypertension, increased to 2 / 3 of systemic pressure
- Eisenmenger syndrome
- Other associated heart disease, requiring surgical solution
- Immuno-compromised patients
- Pathology oncology
- Hematologic or coagulation disorders
- Allergy to contrast medium
- Atypical or calcified Ductus
- Parents or legal guardians who do not accept the risks of catheterization
- Parents or legal guardians and patients who do not accept to sign the letter of consent or who revoke the consent.
- Patients who participated in another clinical investigation during the last 3 months
Data sourced from ClinicalTrials.gov (NCT01063712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.