Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices

German Heart Center Munich

Status: Completed

Conditions: Electromagnetic Interference

Treatments: Other: Security screening procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03264222

GER-EP-017

Details and patient eligibility

About

Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.

Full description

Patients with implanted pacemakers or defibrillators will undergo a screening procedure with an innovative security device. Evaluation will be made with respect to the occurrence of interference.

Enrollment: 379 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• implantable pacemaker or defibrillator in situ

Exclusion criteria

• malfunction of implantable pacemaker or defibrillator
• low battery voltage of implanted cardiac electronic device

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

379 participants in 1 patient group

Exposition to safety screening

Other group

Description:

One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology

Treatment:

Other: Security screening procedure