What side effects are associated with this type of intervention?

Common treatments for Atrial Septal Defect (ASD) include surgical closure and catheter-based procedures. Surgical closure, which involves open-heart surgery, can lead to side effects such as infection, bleeding, arrhythmias, and complications related to anesthesia. Catheter-based procedures, which are less invasive, may result in side effects like bleeding at the catheter insertion site, arrhythmias, and device-related complications such as embolization or residual shunts. Both types of treatments aim to correct the defect but carry risks typical of invasive cardiovascular procedures.

What prior FDA approvals exist?

Atrial Septal Defect (ASD) is typically treated through surgical or catheter-based procedures rather than pharmacological interventions. The FDA has approved devices such as the Amplatzer Septal Occluder and the Gore Helex Septal Occluder for minimally invasive closure of ASDs. These devices are inserted via catheter to provide structural support and close the defect, similar to how batten grafts provide structural support in nasal surgeries. There are no specific drugs approved solely for ASD treatment, as the focus is primarily on mechanical closure techniques.

What other types of research exist?

For nasal valve support, alternatives to Batten grafts include injectable fillers like hyaluronic acid and calcium hydroxylapatite, which can provide structural support and improve airflow. For Atrial Septal Defect (ASD) patients, promising treatments include minimally invasive transcatheter closure techniques and advancements in device technology for ASD closure.

← Back to Search

Batten Grafting for Nasal Valve Collapse

N/A

Recruiting

Led By David Hiltzik, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination

Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices

Must not have

Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty

Septal perforation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial compares adding supportive pieces to standard nasal surgery with just the standard surgery alone. It targets patients with blocked noses due to a crooked septum. The added support helps keep the nose open and improves airflow.

Who is the study for?

This trial is for adults over 18 with breathing obstruction due to a deviated septum, enlarged turbinates, and external nasal valve collapse. Candidates must be able to consent and have these conditions confirmed by clinical examination. It's not for those with septal perforation, untreated/unresponsive allergic rhinitis, past nose surgeries, or concurrent sinus/polyp surgery.

What is being tested?

The study tests if adding batten grafts to standard septoplasty and turbinate reduction improves nasal airflow more effectively than the standard procedure alone. Participants will be divided into two groups: one receiving the combined treatment (intervention arm) and one receiving only the standard treatment (control arm).

What are the potential side effects?

Potential side effects may include discomfort at the graft site, swelling, bleeding, infection risk post-surgery, possible adverse reaction to anesthesia during surgical procedures, and complications related to healing that could affect breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with swollen nasal passages.

Select...

I need surgery to correct my nasal passage according to standard practices.

Select...

My breathing issues are due to septal deviation, turbinate hypertrophy, and external nasal valve collapse.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am chosen for a nose job at the same time as my other procedure.

Select...

I have a hole in the wall dividing my nostrils.

Select...

I have untreated or treatment-resistant allergic rhinitis.

Select...

I have had surgery on my nose or sinuses before.

Select...

I am having or have had surgery for sinus issues or polyp removal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nasal obstruction present finding

Secondary study objectives

Complications and side-effects

Cost-effectiveness (EQ-5D-5L)

Lateral Wall Insufficiency (LWI) scores

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Batten graft, plus septoplasty and inferior turbinate reductionExperimental Treatment3 Interventions

In the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction.

Group II: Septoplasty and inferior turbinate reduction aloneActive Control2 Interventions

In the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atrial Septal Defect (ASD) are surgical closure and percutaneous device closure. Surgical closure involves open-heart surgery to sew the hole in the atrial septum shut, while percutaneous device closure uses a catheter to place a closure device that seals the defect. These treatments are crucial for ASD patients as they prevent complications such as heart failure, arrhythmias, and pulmonary hypertension. Similar to how batten grafts provide structural support to improve nasal airflow, these ASD treatments provide structural integrity to the heart, ensuring proper blood flow and reducing the risk of long-term cardiovascular issues.

Cardiomyocytes of the Heart and Pulmonary Veins: Novel Contributors to Asthma?[Advances in pediatric cardiology and congenital heart diseases].