Percutaneous Pulmonary Artery flow reduction in PAPVD V 1.0
Research type
Research Study
Full 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.
IRAS ID
315128
Contact name
Katherine English
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research 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.
We 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.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0227
Date of REC Opinion
24 Oct 2022
REC opinion
Favourable Opinion