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

NCT04713683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Percutaneous Patent Foramen Ovale Closure

Patients with well-documented embolic stroke of unknown source (ESUS) and a patent foramen ovale (PFO) are indicated for percutaneous closure of PFO. The intervention is performed through the right femoral vein. The interventional cardiologist introduces the sheath and advances the device via inferior vena cava to right atrium. Then, the catheter is passed through the PFO, the device is deployed and the occlusion is achieved. The procedure is performed under fluoroscopy guidance with or without transesophageal echocardiography guidance.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Konstantinos Toutouzas, MD,PhD · First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens

  • Anastasios Apostolos, MD · First Department of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital of Athens

  • Stamatios Gregoriou, MD, PhD · First Department of Dermatology-Venereolgy, National and Kapodistrian University of Athens, Andreas Syggros Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2024-12-01
Completion
2024-12-01
FDA Device
Yes

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713683 on ClinicalTrials.gov