Brief Summary
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.
Brief Title
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
Categories
Completion Date
Completion Date Type
Actual
Conditions
AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular Tachycardia
Heart Disease
Eligibility Criteria
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)
* 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)
Inclusion Criteria
Inclusion Criteria:
* Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor
Pre-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
* Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor
Pre-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
Gender
All
Gender Based
false
Keywords
Cardiac cryoablation
AVNRT
heart disease
tachycardia
AtrioVentricular Nodal Reentrant Tachycardia
Supraventricular tachycardia
SVT
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01426425
Org Class
Industry
Org Full Name
Medtronic Cardiac Ablation Solutions
Org Study Id
ICY-AVNRT
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
Primary Outcomes
Outcome Description
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.
* 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.
Outcome Measure
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
Outcome Time Frame
6 months
Outcome Description
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.
Outcome Measure
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
Outcome Time Frame
6 Months
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
6 Months
Outcome Measure
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andrew Krumerman
Investigator Email
akrumerm@montefiore.org
Investigator Phone
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
TACHYCARDIA, ATRIOVENTRICULAR NODAL REENTRY
TACHYCARDIA, SUPRAVENTRICULAR
HEART DISEASES
TACHYCARDIA
TACHYCARDIA, RECIPROCATING
ARRHYTHMIAS, CARDIAC
CARDIOVASCULAR DISEASES
CARDIAC CONDUCTION SYSTEM DISEASE
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS