Safety of Cardiac Pacemakers in 3 Tesla MRI

University Hospital Bonn (UKB)

Status: Unknown

Conditions: Heart Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT00356330

116/06

Details and patient eligibility

About

To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Full description

Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.

Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.

In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urgent need for an MRI examination

• Stable pacemaker physical parameters

  • Battery voltage > 2.7 V
  • Battery impedance < 2000 Ohm
  • Battery estimated remaining lifetime > 6 months
  • Lead impedances 200-2000 Ohm

• Stable pacing parameters

  • Pacing capture threshold <2.5V at a pulse duration of 0.4ms
  • Sensing > 5mV

• Minimum 3 months since pacemaker and lead implantation

Exclusion criteria

• History of ventricular tachycardia (VT) or ventricular fibrillation
• Unstable angina
• Myocardial infarction within the previous 3 months
• Cardiothoracic surgery within the previous 3 months
• Presence of an abdominal pacemaker with lead length > 70 cm
• Presence of MRI incompatible bioimplants or other MRI incompatible materials