Partial Anomalous Pulmonary Venous ConnectionNCT06048679
Percutaneous Treatment of Partial Anomalous Pulmonary Venous Drainage
A study testing Endovascular pulmonary artery flow-limiting covered stent implantation in people with Partial Anomalous Pulmonary Venous Connection, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Partial anomalous pulmonary venous drainage (PAPVD) occurs in around 1 in every 1000 people. Blood from part of the lung returns to the wrong side of the heart, causing the heart to stretch. This causes breathlessness and heart rhythm problems in later life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Anomalous Pulmonary Venous Connection
- What is being tested?
- Endovascular pulmonary artery flow-limiting covered stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Haemodynamically \& Functionally significant PAPVD (all of the following)
- Right heart dilated on trans thoracic echo
- cardiac MRI Qp:Qs ≥ 1.3:1, and right ventricular to left ventricular volume (RV:LV) ratio ≥ 1.5:1
- Maximal oxygen consumption (VO2 max) on cardiopulmonary exercise testing < 85% predicted
- Normal pulmonary artery pressure
- No contra-indication to pulmonary artery intervention procedure under general anaesthetic
- Able to give informed consent
Who cannot join
- Contra-indication to cardiac MRI
- Not able to give informed consent
- Contra-indication to pulmonary artery intervention under general anaesthetic
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX
Kate English, PhD, kateenglish@nhs.net
About this study
Official title: Is Reducing Flow in Affected Branch Pulmonary Arteries in Patients With Partial Anomalous Pulmonary Venous Drainage Using a Percutaneous Approach Safe and Efficacious? - a Pilot Study
Partial anomalous pulmonary venous drainage (PAPVD) occurs in around 1 in every 1000 people. Blood from part of the lung returns to the wrong side of the heart, causing the heart to stretch. This causes breathlessness and heart rhythm problems in later life. PAPVD can currently only be fixed by open heart surgery, and when the abnormality affects the right lung, even this can be impossible.
This study is designed to examine whether a new keyhole procedure to limit blood flow through the affected lung segments can be safely used to reduce the impact of PAPVD on the heart, reducing symptoms, protecting against heart rhythm problems, and avoiding the need for open heart surgery.
Read more
In this study, a flow limiting device will be positioned in the affected lung artery to reduce blood flow to this segment of lung. The procedure is performed under a general anaesthetic, and is done either as a day case or a single overnight stay in hospital. X-rays are used to guide the positioning of the stent. The procedure is performed as a keyhole procedure through a 3 mm cut in the groin.
The investigators will use heart ultrasound, heart MRI and exercise testing before and six months after the procedure to assess the safety and effect of the flow limiter.
The flow limitation device will either be a standard covered stent used in every day practice, but with a modified balloon for deployment, a vascular plug or similar vascular occlusion device which can be modified to restrict rather than occlude flow. If there is a problem with the flow limitation being too severe, the stent can be fully inflated returning the flow back to normal, and the vascular plug can be retrieved using another key hole procedure.
Read the detailed description
PAPVD has been reported in 0.2% of the population undergoing CT scans and in 0.4 - 0.7% of the population in autopsy studies. They can be associated with superior sinus venosus atrial septal defects or can be present in isolation.
PAPVD causes blood which should be draining from the lungs into the left hand side of the heart to drain into the right side of the heart. Thus PAPVD results in a left to right shunt of varying proportions dependent upon the number of lobes involved. Long term sequelae reflect the impact of the resultant volume loading of the right heart, which can lead to atrial arrhythmia and right heart failure in later life and these patients can develop pulmonary hypertension. Patients with significant left to right shunts often present with symptoms of breathlessness and poor exercise tolerance, which worsen as they age.
Historically, PAPVD has only been considered suitable for surgical repair. This requires an open heart procedure, including cardio-pulmonary bypass, and necessitates around a week in hospital, and a three month recovery period. Surgical repair is technically challenging due to anatomical considerations, particularly in right sided anomalous veins, and there is a relatively high risk of pulmonary venous thrombosis post operatively due to low velocity venous flow. Current European Society of Cardiology guidelines recommend that technical suitability for repair and operative risk must be weighed against the potential benefit of intervention. These guidelines also state that it is unusual for a single anomalous pulmonary venous connection of only one pulmonary lobe to result in a sufficient volume load to justify the risk of surgical repair.
- Being tested
- Endovascular pulmonary artery flow-limiting covered stent implantation
- Keywords
- congenital heart disease
- 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.
Endovascular pulmonary artery flow-limiting covered stent implantationDevice
selective reduction of flow in the pulmonary arteries affected by anomalous pulmonary venous drainage using a modified flow-limiting covered stent
| Study group | Role | What they receive |
|---|---|---|
| main | Other | Not described Receives: Device: Endovascular pulmonary artery flow-limiting covered stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular end diastolic volume
changes in right ventricular end diastolic volume assessed by MRI
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startJan 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Partial Anomalous Pulmonary Venous ConnectionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048679
- Sponsor's protocol ID
- PA22/149367
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haramati LB, Moche IE, Rivera VT, Patel PV, Heyneman L, McAdams HP, Issenberg HJ, White CS. Computed tomography of partial anomalous pulmonary venous connection in adults. J Comput Assist Tomogr. 2003 Sep-Oct;27(5):743-9. doi: 10.1097/00004728-200309000-00011.
PubMed 14501365HEALEY JE Jr. An anatomic survey of anomalous pulmonary veins: their clinical significance. J Thorac Surg. 1952 May;23(5):433-44. No abstract available.
PubMed 14928263Hegde M, Manjunath SC, Usha MK. Isolated Partial Anomalous Pulmonary Venous Connection: Development of Volume Overload and Elevated Estimated Pulmonary Pressure in Adults. J Clin Imaging Sci. 2019 Jun 14;9:29. doi: 10.25259/JCIS-8-2019. eCollection 2019.
PubMed 31508264Lewis RA, Billings CG, Bolger A, Bowater S, Charalampopoulos A, Clift P, Elliot CA, English K, Hamilton N, Hill C, Hurdman J, Jenkins PJ, Johns C, MacDonald S, Oliver J, Papaioannou V, Rajaram S, Sabroe I, Swift AJ, Thompson AAR, Kiely DG, Condliffe R. Partial anomalous pulmonary venous drainage in patients presenting with suspected pulmonary hypertension: A series of 90 patients from the ASPIRE registry. Respirology. 2020 Oct;25(10):1066-1072. doi: 10.1111/resp.13815. Epub 2020 Apr 6.
PubMed 32249494Geva T, Martins JD, Wald RM. Atrial septal defects. Lancet. 2014 May 31;383(9932):1921-32. doi: 10.1016/S0140-6736(13)62145-5. Epub 2014 Apr 8.
PubMed 24725467Stewart RD, Bailliard F, Kelle AM, Backer CL, Young L, Mavroudis C. Evolving surgical strategy for sinus venosus atrial septal defect: effect on sinus node function and late venous obstruction. Ann Thorac Surg. 2007 Nov;84(5):1651-5; discussion 1655. doi: 10.1016/j.athoracsur.2007.04.130.
PubMed 17954078Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available.
PubMed 32860028
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Reducing Flow in Affected Branch Pulmonary Arteries in Patients With Partial Anomalous Pulmonary Venous Drainage Using a Percutaneous Approach Safe and Efficacious? - a Pilot Study
- ClinicalTrials.gov ID
- NCT06048679
- Acronym / sponsor ID
- PA22/149367
- Keywords
- congenital heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Partial anomalous pulmonary venous drainage (PAPVD) occurs in around 1 in every 1000 people. Blood from part of the lung returns to the wrong side of the heart, causing the heart to stretch. This causes breathlessness and heart rhythm problems in later life. PAPVD can currently only be fixed by open heart surgery, and when the abnormality affects the right lung, even this can be impossible.
This study is designed to examine whether a new keyhole procedure to limit blood flow through the affected lung segments can be safely used to reduce the impact of PAPVD on the heart, reducing symptoms, protecting against heart rhythm problems, and avoiding the need for open heart surgery.
In this study, a flow limiting device will be positioned in the affected lung artery to reduce blood flow to this segment of lung. The procedure is performed under a general anaesthetic, and is done either as a day case or a single overnight stay in hospital. X-rays are used to guide the positioning of the stent. The procedure is performed as a keyhole procedure through a 3 mm cut in the groin.
The investigators will use heart ultrasound, heart MRI and exercise testing before and six months after the procedure to assess the safety and effect of the flow limiter.
The flow limitation device will either be a standard covered stent used in every day practice, but with a modified balloon for deployment, a vascular plug or similar vascular occlusion device which can be modified to restrict rather than occlude flow. If there is a problem with the flow limitation being too severe, the stent can be fully inflated returning the flow back to normal, and the vascular plug can be retrieved using another key hole procedure.
Detailed description
PAPVD has been reported in 0.2% of the population undergoing CT scans and in 0.4 - 0.7% of the population in autopsy studies. They can be associated with superior sinus venosus atrial septal defects or can be present in isolation.
PAPVD causes blood which should be draining from the lungs into the left hand side of the heart to drain into the right side of the heart. Thus PAPVD results in a left to right shunt of varying proportions dependent upon the number of lobes involved. Long term sequelae reflect the impact of the resultant volume loading of the right heart, which can lead to atrial arrhythmia and right heart failure in later life and these patients can develop pulmonary hypertension. Patients with significant left to right shunts often present with symptoms of breathlessness and poor exercise tolerance, which worsen as they age.
Historically, PAPVD has only been considered suitable for surgical repair. This requires an open heart procedure, including cardio-pulmonary bypass, and necessitates around a week in hospital, and a three month recovery period. Surgical repair is technically challenging due to anatomical considerations, particularly in right sided anomalous veins, and there is a relatively high risk of pulmonary venous thrombosis post operatively due to low velocity venous flow. Current European Society of Cardiology guidelines recommend that technical suitability for repair and operative risk must be weighed against the potential benefit of intervention. These guidelines also state that it is unusual for a single anomalous pulmonary venous connection of only one pulmonary lobe to result in a sufficient volume load to justify the risk of surgical repair.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main | Other | Device: Endovascular pulmonary artery flow-limiting covered stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Haemodynamically \& Functionally significant PAPVD (all of the following)
- No contra-indication to pulmonary artery intervention procedure under general anaesthetic
- Able to give informed consent
Key exclusion criteria (3 listed)
- Contra-indication to cardiac MRI
- Not able to give informed consent
- Contra-indication to pulmonary artery intervention under general anaesthetic
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 |
|---|---|---|
| Endovascular pulmonary artery flow-limiting covered stent implantationselective reduction of flow in the pulmonary arteries affected by anomalous pulmonary venous drainage using a modified flow-limiting covered stent | Device | main |
Primary outcome
Right ventricular end diastolic volume
Time frame: 6 months post procedure
changes in right ventricular end diastolic volume assessed by MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 14501365Haramati LB, Moche IE, Rivera VT, Patel PV, Heyneman L, McAdams HP, Issenberg HJ, White CS. Computed tomography of partial anomalous pulmonary venous connection in adults. J Comput Assist Tomogr. 2003 Sep-Oct;27(5):743-9. doi: 10.1097/00004728-200309000-00011.
- Background: PubMed 14928263HEALEY JE Jr. An anatomic survey of anomalous pulmonary veins: their clinical significance. J Thorac Surg. 1952 May;23(5):433-44. No abstract available.
- Background: PubMed 31508264Hegde M, Manjunath SC, Usha MK. Isolated Partial Anomalous Pulmonary Venous Connection: Development of Volume Overload and Elevated Estimated Pulmonary Pressure in Adults. J Clin Imaging Sci. 2019 Jun 14;9:29. doi: 10.25259/JCIS-8-2019. eCollection 2019.
- Background: PubMed 32249494Lewis RA, Billings CG, Bolger A, Bowater S, Charalampopoulos A, Clift P, Elliot CA, English K, Hamilton N, Hill C, Hurdman J, Jenkins PJ, Johns C, MacDonald S, Oliver J, Papaioannou V, Rajaram S, Sabroe I, Swift AJ, Thompson AAR, Kiely DG, Condliffe R. Partial anomalous pulmonary venous drainage in patients presenting with suspected pulmonary hypertension: A series of 90 patients from the ASPIRE registry. Respirology. 2020 Oct;25(10):1066-1072. doi: 10.1111/resp.13815. Epub 2020 Apr 6.
- Background: PubMed 24725467Geva T, Martins JD, Wald RM. Atrial septal defects. Lancet. 2014 May 31;383(9932):1921-32. doi: 10.1016/S0140-6736(13)62145-5. Epub 2014 Apr 8.
- Background: PubMed 17954078Stewart RD, Bailliard F, Kelle AM, Backer CL, Young L, Mavroudis C. Evolving surgical strategy for sinus venosus atrial septal defect: effect on sinus node function and late venous obstruction. Ann Thorac Surg. 2007 Nov;84(5):1651-5; discussion 1655. doi: 10.1016/j.athoracsur.2007.04.130.
- Background: PubMed 32860028Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular pulmonary artery flow-limiting covered stent implantation in people with Partial Anomalous Pulmonary Venous Connection, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate English (0113 3925748, ltht.researchoffice@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular end diastolic volume (time frame: 6 months post procedure). 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 NCT06048679, which also lists 7 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 21 Sep 2023.