CompletedPhase 4

CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

United States105 participantsStarted 2006-12

Plain-language summary

The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with a clinical history of AVNRT who are referred for ablation.
✓. Patients willing to provide written informed consent.

Exclusion criteria

✕. Patients with any pre-existing AV block.
✕. Patients with known cryoglobulinemia

What they're measuring

Device or Procedure Related AV Block Persistent Through Discharge From Hospital.

Timeframe: After 250 subjects have been enrolled.

Trial details

NCT IDNCT00621621

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2014-07-22

View on ClinicalTrials.gov More Tachycardia, Atrioventricular Nodal Reentry trials