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Congenital Heart DiseasePhase 2NCT01063712

Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"

A Phase 2 study testing Nit-Occlud® PDA-R in people with Congenital Heart Disease, run by pfm S.R.L. at 1 site in Bolivia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Congenital Heart Disease
What is being tested?
Nit-Occlud® PDA-R
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteBolivia
Study dates
Jun 2009to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Bolivia1 site

  • Kardiozentrum and Surgical Medical Center Boliviano Belga

    La Paz, Murillo, 100

Other trials in Bolivia

About this study

Official title: Safety and Effectiveness of the Device "Nit-Occlud® PDA-R" for Percutaneous Closure of Patent Arterial Duct Between 2 and 8 mm in Patients Treated Interventionally in Specialized Centers

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.

Read the detailed description

During the years 2003 to 2008, the Cardiological Medical Center "Kardiozentrum" evaluated 1136 patients with echocardiographic studies, 14.7% of the patients were diagnosed with patent arterial duct. The PDA is an abnormal communication between the aorta and pulmonary artery. Untreated it can rise the intrapulmonary pressure and lead to serious complications like cardiac insufficiency.

The incidence of ducts as an isolated heart disease is between 3.6 and 7% of all congenital heart diseases at sea level, and 10 - 14% at high altitude; rising up to 20% in cities at more than 2.500 m about sea level. The ducts at high altitude are generally wider and larger than at sea level.

One treatment alternative is a percutaneous transluminal implantation of a permanent implant which closes the defect. The device under investigation "Nit-Occlud® PDA-R" is developed for closure of the PDA with a minimal diameter of 2-8 mm.

The device performs the function of generating the defect occlusion by the body itself. The implant stimulates the body to generate an epithelium over the implant so that the PDA closes.

Being tested
Nit-Occlud® PDA-R
Keywords
Ductus, Patent ductus Arterious, "Nit-Occlud® PDA-R", Interventional closure of PDA, Percutaneous closure
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nit-Occlud® PDA-RDevice

    Also called Device - Med - Nit Occlud PDA

    Transcatheter implantation of a PDA Device (Nitinol) The catheterism was done under sedation, using a protocol established by inserting a catheter through a femoral artery and/or vein directed to the heart and great vessels. Invasive measurements are obtained in the descending aorta and pulmonary artery. Once in ductal position, we inject iodinated contrast medium that allows us to observe via X-ray the ductal morphology; obtaining accurate measurements to choose the appropriate device. The device is then inserted via the catheter, closing the ductus.

    The catheterism provides measures of aortic and pulmonary pressure, before, during and after the closure.

Study groups in NCT01063712
Study groupRoleWhat they receive
Nit-Occlud PDA-ROtherInterventional, prospective clinical study, non randomized.
Receives: Device: Nit-Occlud® PDA-R

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)

    The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.

    Measured: up to one year after percutaneous closure

Secondary outcomes (1)

  1. 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.

    The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.

    Measured: one year after percutaneous closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2010 (estimated)
  2. Study startJun 2009
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01063712
Sponsor's protocol ID
PFM-P034
Other IDs
Bioethics Committee
Status last verified
May 2012
First submitted
4 Feb 2010
Last updated
24 May 2012
Data monitoring committee
Yes

Publications

  • Lang N, Schmitz C, Lehner A, Fuchs F, Heath A, Freudenthal F, Wintersperger BJ, Huber AM, Thein E, Netz H, Kozlik-Feldmann R. Preclinical evaluation of a new self-expanding device for closure of muscular ventricular septal defects in a pig model. Catheter Cardiovasc Interv. 2010 Feb 15;75(3):408-15. doi: 10.1002/ccd.22285.

    PubMed 19882712

  • Heath A, Lang N, Levi DS, Granja M, Villanueva J, Navarro J, Echazu G, Kozlik-Feldmann R, del Nido P, Freudenthal F. Transcatheter closure of large patent ductus arteriosus at high altitude with a novel nitinol device. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):399-407. doi: 10.1002/ccd.23302. Epub 2011 Dec 12.

    PubMed 21805617

  • Freudenthal FP, Heath A, Villanueva J, Mendes J, Vicente X, von Alvensleben I, Echazu G, Navarro J, Lang N, Kozlik-Feldmann R. Chronic hypobaric hypoxia, patent arterial duct and a new interventional technique to close it. Cardiol Young. 2012 Apr;22(2):128-35. doi: 10.1017/S1047951111000990. Epub 2011 Jul 21.

    PubMed 21774843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nit-Occlud® PDA-R in people with Congenital Heart Disease, run by pfm S.R.L. at 1 site in Bolivia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment) (time frame: up to one year after percutaneous closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01063712, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2012.

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