Percutaneous Treatment of Partial Anomalous Pulmonary Venous Drainage

NCT06048679 | Unknown

• 1 other identifier: PA22/149367
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Anomalous Pulmonary Venous Connection

Keywords

congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Right ventricular end diastolic volume

  changes in right ventricular end diastolic volume assessed by MRI

  6 months post procedure

Study Arms (1)

main

OTHER

Device: Endovascular pulmonary artery flow-limiting covered stent implantation

Interventions

Endovascular pulmonary artery flow-limiting covered stent implantation DEVICE

selective reduction of flow in the pulmonary arteries affected by anomalous pulmonary venous drainage using a modified flow-limiting covered stent

main

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contra-indication to cardiac MRI
• Not able to give informed consent
• Contra-indication to pulmonary artery intervention under general anaesthetic

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 14501365 BACKGROUND

• 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.

  PMID: 14928263 BACKGROUND

• 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.

  PMID: 31508264 BACKGROUND

• 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.

  PMID: 32249494 BACKGROUND

• 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.

  PMID: 24725467 BACKGROUND

• 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.

  PMID: 17954078 BACKGROUND

• 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.

  PMID: 32860028 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Kate English

CONTACT

0113 3925748; ltht.researchoffice@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)