Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
|ClinicalTrials.gov Identifier: NCT01426425|
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : March 31, 2017
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|AtrioVentricular Nodal Reentrant Tachycardia Supraventricular Tachycardia Heart Disease||Device: Freezor Xtra Cryoablation Catheter||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||572 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2016|
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
Device: Freezor Xtra Cryoablation Catheter
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.
- Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach. [ Time Frame: 6 months ]
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.
- Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach. [ Time Frame: 6 Months ]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.
- Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success. [ Time Frame: 6 Months ]If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426425
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|Principal Investigator:||Peter Wells, M.D.||Baylor Univ Medical Ctr Dallas, TX.|