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Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426425
First Posted: August 31, 2011
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
August 29, 2011
August 31, 2011
September 22, 2016
March 31, 2017
March 31, 2017
May 2012
September 2015   (Final data collection date for primary outcome measure)
  • 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.
  • Freezor(R) Extra Chronic effectiveness (through 6 months)for the treatment of AVNRT (AVNRT: Atrioventricular nodal reentrant tachycardia) [ Time Frame: 6 months ]

    Subjects must meet both of the following conditions to be considered as a chronic effectiveness 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 ablation procedure assessment (i.e. acute procedural success)
    • Lack of documented recurrence of clinical AVNRT during the 6 months follow-up period post the successful ablation procedure
  • Freezor(R) Extra Chronic safety (through 6 months)for the treatment of AVNRT [ Time Frame: 6 Months ]
    The primary safety endpoint is a success/failure variable calculated for each subject through 6 months follow-up. Subjects with at least one chronic safety event (serious adverse event determined to be ablation procedure or device related) during the cryoablation procedure and through the end of 6 months follow-up will be considered a primary safety failure.
Complete list of historical versions of study NCT01426425 on ClinicalTrials.gov Archive Site
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.
Freezor(R) Extra Chronic effectiveness (through 6 months)for the treatment of AVNRT in subjects who have achieved acute procedural success. [ Time Frame: 6 Months ]
Demonstrate the chronic effectiveness (Lack of documented recurrence of clinical AVNRT) of the Freezor® Xtra CryoAblation Catheter in the treatment of AVNRT through 6 months in subjects who have achieved acute procedural success.
Not Provided
Not Provided
 
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • AtrioVentricular Nodal Reentrant Tachycardia
  • Supraventricular Tachycardia
  • Heart Disease
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.
Experimental: Cryoablation
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
Intervention: Device: Freezor Xtra Cryoablation Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
572
September 2016
September 2015   (Final data collection date for primary outcome measure)

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 ventricular tachycardia
  • Atrial tachycardia or other arrhythmia that could be confused with AVNRT
  • Reversible cause of SVT
  • History of previous AVNRT ablation
  • Therapy with amiodarone within last 90 days
  • Unstable angina/myocardial infarction/open heart surgery in past 60 days
  • New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days
  • Implantable cardiac rhythm device
  • Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block
  • Stroke or transient ischemic attack within the past 180 days
  • Life expectancy less than 12 months
  • Female known to be pregnant
  • Unable/unwilling to give informed consent
  • Unable/unwilling to comply with follow-up visits and study requirements
  • Less than 18 years of age
  • Active systemic infection
  • Cryoglobulinemia
  • Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus)
  • Participating in a concurrent clinical study that may confound the results of this study

Post-Electrophysiology Study Inclusion Criteria:

  • Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT.

Post-Electrophysiology Study Exclusion Criteria:

  • Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months
  • Presence of inducible sustained ventricular tachycardia or fibrillation
  • Presence of an accessory pathway
  • Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system.
  • Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01426425
ICY-AVNRT
Yes
Not Provided
Not Provided
Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
Principal Investigator: Peter Wells, M.D. Baylor Univ Medical Ctr Dallas, TX.
Medtronic Atrial Fibrillation Solutions
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP