Medtronic CRYSTAL AF Study

Study ID
STU 112010-091

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Anne Leyretana-Zabat
214-590-5015
anne.leyretana-zabat@utsouthwestern.edu

Principal Investigator
James Daniels

Summary

The study is expected to be conducted globally at approximately 60 centers located in europe, united States of america, and Canada. approximately 450 subjects will be enrolled in the study. Subjects will be randomized to the Continuous Monitoring arm using Reveal XT or the Control arm by standard of care on a 1:1 basis. Study subjects from all geographies will be followed for at least 12 months (from enrollment until the last subject enrolled completes 12-month Follow-up) or until a study closure decision by Medtronic or regulatory authority, whichever occurs first. accordingly, the expected study duration is approximately 36 months (first enrollment until end of last subject 12-month Follow-up). To ensure a widespread distribution of data and minimize center bias in the study results, participating centers are expected to enroll at least 10 subjects and a maximum of 45 subjects (~10% of total subjects to be enrolled).

Participant Eligibility

Criteria for Inclusion of Subjects:


* Patient has recent (<90 days: target is 15 days after event) episode of
cryptogenic symptomatic transient ischemic attack* (TIA) or recent episode of
cryptogenic ischemic stroke, indicating that the patient is at increased risk of
atrial fibrillation.

A stroke/TIA is considered to be cryptogenic if no possible cause can be
determined despite extensive work-up according to the standard protocol of the
participating center.
Before randomization the following tests are minimally required as
standard tests to establish the diagnosis of cryptogenic stroke:

* MRI or CT

* 12-lead ECG for AF detection

* 24-hour ECG monitoring for AF detection and PAC analysis (e.g. Holter)

* Transesophageal echocardiography (TEE)

* CTA or MRA of head and neck to rule out arterial pathologies
For patients > 55 years of age:
Ultrasound of cervical arteries and Transcranial Doppler/Transcranial Color Coded
Doppler (TCD/TCCD) of intracranial vessels or

Magnetic resonance Angiography (MRA) of head and neck or Computer
Tomography Angiography (CTA) of head and neck or catheter angiography of head
and neck.

Patients in which ultrasound testing is not possible due to lack of a temporal
window require MRA, CTA, or catheter angiography of the head and neck.
For patients < or = 55 years of age:
MRA or head and neck or CTA of head and neck or catheter angiography of the
head and neck.


* Patient or legally authorized representative is willing to sign patient consent form


* Patient is 40 years or older
Only TIAs with the following documented characteristics can be included:
Visible lesion on MRI or CT that fits the symptoms of the TIA and at least one of
the following symptoms:

* Speech problems

* Weakness of arm or leg

* Hemianopsia