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Freezor Xtra Cryoablation Catheter · 1 trial · 3 indications
Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: * Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. * Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.
Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.
| Arm | Type | Description |
|---|---|---|
| Cryoablation | EXPERIMENTAL | Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra. |
| Name | Type | Description |
|---|---|---|
| Freezor Xtra Cryoablation Catheter | DEVICE | Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach. |
Pre-Electrophysiology Study Inclusion Criteria: * Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor Pre-Electrophysiology Study Exclusion Criteria: * History of sustained (≥30 seconds) of ventri...
Freezor Xtra Cryoablation Catheter is used for AtrioVentricular Nodal Reentrant Tachycardia, a type of supraventricular tachycardia. It is a cardiovascular therapeutic device being investigated for this condition. The device is in Phase 3 clinical development and is not yet approved.
Freezor Xtra Cryoablation Catheter is developed by Medtronic plc., a medical technology company. Medtronic is publicly traded under the ticker symbol MDT. The device is currently in Phase 3 clinical trials for the treatment of AtrioVentricular Nodal Reentrant Tachycardia.
Freezor Xtra Cryoablation Catheter is in Phase 3 clinical development. It is an investigational device for treating AtrioVentricular Nodal Reentrant Tachycardia. The Phase 3 trial has been completed, but the device has not been approved for marketing.
Freezor Xtra Cryoablation Catheter has one completed Phase 3 trial, NCT01426425, titled Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia. The trial enrolled 572 participants in the United States and Canada, with adults aged 18 years and older.
Freezor Xtra Cryoablation Catheter is not FDA approved. It is an investigational device currently in Phase 3 clinical development for AtrioVentricular Nodal Reentrant Tachycardia. The Phase 3 trial has been completed, but regulatory approval has not been granted.