Patent Ductus ArteriosusPIVOTALNCT03982342

Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

A study testing Cather closure of patent ductus arteriosus (PDA) and Conservative management of patent ductus arteriosus (PDA) in people with Patent Ductus Arteriosus, run by Nationwide Children's Hospital at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 14 to 28 days
Conditions the study is for: Patent Ductus Arteriosus
What is being tested?: Cather closure of patent ductus arteriosus (PDA) and Conservative management of patent ductus arteriosus (PDA)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 2 sitesUnited States
Study dates: 10 Oct 2020to 31 Aug 2021
Phase: Interventional
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 14 to 28 days
All sexes
No healthy volunteers
Child

Who may be able to join

Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent ductus arteriosus (PDA) at 2 - 4 weeks of age.
Body weight greater than or equal to 700 grams

Who cannot join

Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities
Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal defects (ex. Tetrology of Fallot, Single ventricle physiology)
Body weight less than 700 grams

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Tennessee Health Science Center
Memphis, Tennessee, 38163

Other trials in United States

About this study

Official title: Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)

This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term infants, but in many preterm infants, it remains open (patent). A PDA may present a complication for a number of short-term problems faced by preterm infants. Longer-term issues include the development of pulmonary hypertension and changes in the size and performance of the heart. There is ongoing debate as to whether or not the PDA requires intervention.

Read the detailed description

Preterm infants diagnosed with a hemodynamically-significant patent ductus arteriosus (HSPDA) will be included. Specific criteria will be followed to determine if a patent ductus arteriosus (PDA) is "hemodynamically significant". Infants will be randomized to two different approaches for management of the PDA. The first will be catheter-based closure (intervention) and the second will be conservative management (non-intervention). Both procedures are standard practice at many institutions, including Nationwide Children's Hospital. Infants randomized to receive intervention will undergo a procedure in which a catheter is used to place an FDA-approved device within the PDA, to close it (like a plug). Infants randomized to the conservative management (non-intervention) group will be permitted time to see if the PDA closes on its own, naturally. However, if the PDA remains open and intervention is deemed medically necessary, they will also undergo the catheter closure procedure.

Conditions: Patent Ductus Arteriosus
Being tested: Cather closure of patent ductus arteriosus (PDA), Conservative management of patent ductus arteriosus (PDA)
Keywords: catheter closure, conservative treatment, percutaneous closure
Medical subject headings: Ductus Arteriosus, Patent

What participants receive

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

Cather closure of patent ductus arteriosus (PDA)Device
Also called Percutaneous closure of patent ductus arteriosus (PDA)
Infants assigned to this group will have a catheter run from a blood vessel in the upper leg / groin area to the heart, where an FDA-approved device will be placed within the patent ductus arteriosus to occlude or plug it, thereby closing the ductus.
Conservative management of patent ductus arteriosus (PDA)Other
Infants with a hemodynamically-significant patent ductus arteriosus randomized to this group will be treated by fluid restriction and possible diuretic use to reduce PDA symptoms, and allow time to permit the PDA to close or become reduced in size to the point where it is no longer considered "hemodynamically-significant".

Study groups in NCT03982342
Study group	Role	What they receive
Catheter-closure of PDA	Active comparator	Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA). Receives: Device: Cather closure of patent ductus arteriosus (PDA)
Conservative management of PDA	Active comparator	Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary. Receives: Device: Cather closure of patent ductus arteriosus (PDA); Other: Conservative management of patent ductus arteriosus (PDA)

What is being measured

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

Time on Ventilatory Support Required
Period the participant is in need of ventilator support [Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar]
Measured: Weekly for 1 month pre-closure (intervention group) or corresponding time point (non-intervention group); Weekly for 1 month post-closure (intervention group) or corresponding time point (non-intervention group); 36 weeks corrected gestational age
Supplemental Oxygen Need
Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)
Measured: Post-randomization (up to 6 weeks) for participants in both groups.

Secondary outcomes (1)

Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)
How often (incidence) infants assigned to conservative management require intervention; failure of treatment method
Measured: 6 weeks post-randomization (to conservative management group)

Timeline

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

10 Oct 202031 Aug 2021

First posted11 Jun 2019
Study start10 Oct 2020
Primary completion31 Aug 2021
Study completion31 Aug 2021

Why it stopped: COVID outbreak interrupted study recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03982342
Sponsor's protocol ID: STUDY00000295
Acronym: PIVOTAL
Status last verified: Feb 2024
First submitted: 16 May 2019
Last updated: 7 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Shah ZS, Clark RH, Patt HA, Backes CH Jr, Tolia VN. Trends in Procedural Closure of the Patent Ductus Arteriosus among Infants Born at 22 to 30 Weeks' Gestation. J Pediatr. 2023 Dec;263:113716. doi: 10.1016/j.jpeds.2023.113716. Epub 2023 Aug 31.
PubMed 37659585

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth

All Patent Ductus Arteriosus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)
ClinicalTrials.gov ID: NCT03982342
Acronym / sponsor ID: PIVOTAL / STUDY00000295
Conditions: Patent Ductus Arteriosus
Keywords: catheter closure, conservative treatment, percutaneous closure
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID outbreak interrupted study recruitment
Enrolment: 1 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Collaborators: University of Tennessee
Study start: 10 Oct 2020 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 11 Jun 2019 (actual)
Results: Posted 7 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Enrolled participants will be randomly assigned to one of two PDA treatment approaches, both receiving treatment at the same time.

Arm	Type	Receives
Catheter-closure of PDA	Active comparator	Device: Cather closure of patent ductus arteriosus (PDA)Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).
Conservative management of PDA	Active comparator	Device: Cather closure of patent ductus arteriosus (PDA), Other: Conservative management of patent ductus arteriosus (PDA)Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary.

Who may qualify

Ages: 14 to 28 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent ductus arteriosus (PDA) at 2 - 4 weeks of age.
Body weight greater than or equal to 700 grams

Key exclusion criteria (3 listed)

Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities
Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal defects (ex. Tetrology of Fallot, Single ventricle physiology)
Body weight less than 700 grams

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cather closure of patent ductus arteriosus (PDA)Also: Percutaneous closure of patent ductus arteriosus (PDA)Infants assigned to this group will have a catheter run from a blood vessel in the upper leg / groin area to the heart, where an FDA-approved device will be placed within the patent ductus arteriosus to occlude or plug it, thereby closing the ductus.	Device	Catheter-closure of PDA, Conservative management of PDA
Conservative management of patent ductus arteriosus (PDA)Infants with a hemodynamically-significant patent ductus arteriosus randomized to this group will be treated by fluid restriction and possible diuretic use to reduce PDA symptoms, and allow time to permit the PDA to close or become reduced in size to the point where it is no longer considered "hemodynamically-significant".	Other	Conservative management of PDA

Primary outcome

Time on Ventilatory Support Required
Time frame: Weekly for 1 month pre-closure (intervention group) or corresponding time point (non-intervention group); Weekly for 1 month post-closure (intervention group) or corresponding time point (non-intervention group); 36 weeks corrected gestational age
Period the participant is in need of ventilator support [Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar]
Supplemental Oxygen Need
Time frame: Post-randomization (up to 6 weeks) for participants in both groups.
Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)

1 secondary outcome

Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)
Time frame: 6 weeks post-randomization (to conservative management group)

Results and safety

Results posted to the registry on 7 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Catheter-closure of PDA	0	0
Conservative Management of PDA	1	1

Primary outcome: Time on Ventilatory Support Required

Time frame: Weekly for 1 month pre-closure (intervention group) or corresponding time point (non-intervention group); Weekly for 1 month post-closure (intervention group) or corresponding time point (non-intervention group); 36 weeks corrected gestational age. Number. Unit: weeks

Measure	Catheter-closure of PDA n = 0	Conservative Management of PDA n = 1
Value	–	4

Population analysed: Single participant enrolled in preliminary trial, randomized to conservative management group. Period specified as outcome is the time (in weeks) post-randomization / group assignment that the subject continued to require ventilatory (SIMV) support.

Primary outcome: Supplemental Oxygen Need

Time frame: Post-randomization (up to 6 weeks) for participants in both groups.. Number. Unit: percentage of oxygen

Measure	Catheter-closure of PDA n = 0	Conservative Management of PDA n = 1
Enrollment	–	90
Week 1	–	63
Week 2	–	46
Week 3	–	40
Week 4	–	38
Week 5	–	38
Week 6	–	38

Population analysed: Supplemental oxygen required while undergoing assigned treatment. If assignment was to the Conservative management group and rescue intervention was needed, this applies to the period prior to intervention. The calculation begins using the percentage oxygen on timepoint 0 (day 1, enrollment and randomization) using the weekly supplementary oxygen percentages (on day 7, day 14, day 21, etc up to day 56 post-randomization).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs): monitored weekly during hospitalization until discharge or up to 10 months. AEs specific to subjects undergoing catheter closure (noted below) will be monitored based upon the situation: 1) During the procedure (e.g., equipment failure, need for transfusion, intra-procedural embolization); 2) daily thereafter for one week (e.g., bruising at catheterization site, post-procedural embolization); 3) daily until resolution (e.g., blood clot formation requiring anticoagulation).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Catheter-closure of PDA	0 of 0	0 of 0	0
Conservative Management of PDA	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): The trial only enrolled a single patient prior to the COVID-19 epidemic. Due to subsequent COVID-19 restrictions placed upon clinical trials, the study was terminated early.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37659585Shah ZS, Clark RH, Patt HA, Backes CH Jr, Tolia VN. Trends in Procedural Closure of the Patent Ductus Arteriosus among Infants Born at 22 to 30 Weeks' Gestation. J Pediatr. 2023 Dec;263:113716. doi: 10.1016/j.jpeds.2023.113716. Epub 2023 Aug 31.
Individual participant dataSharing planned: No

Related trials for Patent Ductus Arteriosus

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carl H Backes, MD principal investigator

Nationwide Children's Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2024). 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?

Time on Ventilatory Support Required (time frame: Weekly for 1 month pre-closure (intervention group) or corresponding time point (non-intervention group); Weekly for 1 month post-closure (intervention group) or corresponding time point (non-intervention group); 36 weeks corrected gestational age). The study lists 2 primary outcomes in all. 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 NCT03982342, which also lists 1 linked publication.

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 7 Feb 2024.