Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder — INSPIRE  

Foramen Ovale, Patent Clinical Trial

Official title: Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder; a RandomizEd Trial.

Status Recruiting

Clinical Trial Summary

Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients. The devices used for the specific purpose contain and release nickel, which is considered as the most allergen metal in nature. Skin patch tests are considered as gold-standard for documenting nickel allergy. While the allergic contact dermatitis induced by nickel is well described, literature is inadequate on explaining the effect of nickel release on the clinical manifestations of patients implanted with such devices.

Our prospective, randomized, blinded trial will try to investigate the above by performing nickel skin patch tests to all patients, 14 days before and 90 days after the implantation. During follow-up, clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests.

Clinical Trial Description

Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes, after embolic stroke of unknown source (ESUS) and a patent foramen ovale. The PFO closure is achieved by the implantation of suitable devices, which occlude the shunt between the two atria and prevent the creation and detachment of thrombi. Until today, there are two devices approved by FDA for the specific purpose; Amplatzer PFO Occluder and Gore Cardioform Septal Occluder. Despite the architectonic differences between these devices, the main material of both is nitinol, an alloy of nickel and titanium. While titanium is an extremely rare allergen, nickel is considered as one of the most common allergens and the most frequent metal allergen in nature, with a prevalence about 20%. The main clinical expression of nickel hypersensitivity is allergic contact dermatitis, but cases with systemic allergic reaction have been described as well. It has been observed that nickel is released by the implanted devices and circulates through bloodstream, having the potential to cause systemic clinical picture. Device syndrome includes signs and symptoms (i.e. palpitations, dyspnea, chest pain, rash, etc.), which are appeared after the device placement and are associated with hypersensitivity reaction. The existing literature is considered as inadequate for explaining the effect of nickel release in the patients implanted with an occluder.

Our trial will try to investigate the impact of device placement to nickel skin patch test results and the correlation with the clinical manifestations of patients. Considering that, skin patch tests for nickel and other allergens will be performed in all included patients, 14 days prior and 90 days after the procedure. The patients will be randomized to receive either Amplatzer or Gore device, with parallel assignment and randomization 1:1. During follow-up, clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests. The time frame of 90 days has been selected, due to the duration of device's endothelization and nickel release. ;

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Contact Irritant
• Foramen Ovale, Patent
• Metal Allergy
• Nickel Sensitivity

• NCT number: NCT04713683
• Study type: Interventional
• Source: National and Kapodistrian University of Athens
• Contact: Anastasios Apostolos, MD, PhD
• Phone: 6980870458
• Email: anastasisapostolos@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2020
• Completion date: September 1, 2024