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Percutaneous Treatment of Partial Anomalous Pulmonary Venous Drainage

Primary Purpose

Partial Anomalous Pulmonary Venous Connection

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endovascular pulmonary artery flow-limiting covered stent implantation
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Partial Anomalous Pulmonary Venous Connection focused on measuring congenital heart disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Contra-indication to cardiac MRI Not able to give informed consent Contra-indication to pulmonary artery intervention under general anaesthetic

Sites / Locations

  • Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

main

Arm Description

Outcomes

Primary Outcome Measures

Right ventricular end diastolic volume
changes in right ventricular end diastolic volume assessed by MRI

Secondary Outcome Measures

Full Information

First Posted
August 24, 2023
Last Updated
September 14, 2023
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT06048679
Brief Title
Percutaneous Treatment of Partial Anomalous Pulmonary Venous Drainage
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Anomalous Pulmonary Venous Connection
Keywords
congenital heart disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
main
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Endovascular pulmonary artery flow-limiting covered stent implantation
Intervention Description
selective reduction of flow in the pulmonary arteries affected by anomalous pulmonary venous drainage using a modified flow-limiting covered stent
Primary Outcome Measure Information:
Title
Right ventricular end diastolic volume
Description
changes in right ventricular end diastolic volume assessed by MRI
Time Frame
6 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Contra-indication to cardiac MRI Not able to give informed consent Contra-indication to pulmonary artery intervention under general anaesthetic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate English
Phone
0113 3925748
Email
ltht.researchoffice@nhs.net
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate English, PhD
Email
kateenglish@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14501365
Citation
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.
Results Reference
background
PubMed Identifier
14928263
Citation
HEALEY JE Jr. An anatomic survey of anomalous pulmonary veins: their clinical significance. J Thorac Surg. 1952 May;23(5):433-44. No abstract available.
Results Reference
background
PubMed Identifier
31508264
Citation
Hegde 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.
Results Reference
background
PubMed Identifier
32249494
Citation
Lewis 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.
Results Reference
background
PubMed Identifier
24725467
Citation
Geva 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.
Results Reference
background
PubMed Identifier
17954078
Citation
Stewart 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.
Results Reference
background
PubMed Identifier
32860028
Citation
Baumgartner 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.
Results Reference
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Percutaneous Treatment of Partial Anomalous Pulmonary Venous Drainage

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