Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

September 17, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

572

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Cardiac Arrhythmia Trials, Inc.
    • Ontario
      • London, Ontario, Canada, N6A 5B9
        • London Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H3A 1A1
        • Hopital Du Sacre Coeur de Montreal
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P OW5
        • Prairie CardioVascular Research Network
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Medical Center
    • California
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Institute
      • Saint Paul, Minnesota, United States, 55102
        • HealthEast St. Joseph's Hospital
    • New York
      • Bay Shore, New York, United States, 11706
        • Southside Hospital
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Sanger Heart and Vascular Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Dayton, Ohio, United States, 45409
        • Miami Valley Cardiologists
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Sacred Heart Medical Center
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Cardiovascular Associates
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley Medical Center
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont Cardiovascular Heart Institute
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Heart and Vascular Hospital
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal
      • Plano, Texas, United States, 75093
        • Baylor Research Institute
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cryoablation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: Peter Wells, M.D., Baylor Univ Medical Ctr Dallas, TX.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

August 29, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (ESTIMATE)

August 31, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICY-AVNRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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