Percutaneous Treatment of Partial Anomalous Pulmonary Venous Drainage

September 14, 2023 updated by: The Leeds Teaching Hospitals NHS Trust

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS1 3EX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: main
Device: Endovascular pulmonary artery flow-limiting covered stent implantation
selective reduction of flow in the pulmonary arteries affected by anomalous pulmonary venous drainage using a modified flow-limiting covered stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular end diastolic volume
Time Frame: 6 months post procedure
changes in right ventricular end diastolic volume assessed by MRI
6 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Leeds Teaching Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA22/149367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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