AtrioVentricular Nodal Reentrant TachycardiaPhase 3NCT01426425

Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

A Phase 3 study testing Freezor Xtra Cryoablation Catheter in people with AtrioVentricular Nodal Reentrant Tachycardia and Supraventricular Tachycardia, run by Medtronic Cardiac Ablation Solutions at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
What is being tested?: Freezor Xtra Cryoablation Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 572 participants
Where: 34 sitesin 2 countries
Study dates: May 2012to Sep 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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)

Trial locations and contacts

34 sites in 2 countries.

Country

City, postcode or hospital

34 sites in 2 countries

United States26 sites

University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Atlanta, Georgia, 30309
Southside Hospital
Bay Shore, New York, 11706
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, 17011
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28203
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226
Geisinger Medical Center
Danville, Pennsylvania, 17822
Miami Valley Cardiologists
Dayton, Ohio, 45409
Iowa Heart Center
Des Moines, Iowa, 50314
Virginia Heart
Falls Church, Virginia, 22042
St. Luke's Episcopal
Houston, Texas, 77030
Wellmont Cardiovascular Heart Institute
Kingsport, Tennessee, 37660
Baptist Hospital of Miami
Miami, Florida, 33176
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Orlando Regional Medical Center
Orlando, Florida, 32806
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Baylor Research Institute
Plano, Texas, 75093
University of Rochester Medical Center
Rochester, New York, 14642
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426
Healtheast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
Pacific Heart Institute
Santa Monica, California, 90404
Sacred Heart Medical Center
Springfield, Oregon, 97477
Stanford Hospital and Clinics
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

Canada8 sites

Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
London Health Sciences Centre
London, Ontario, N6A 5B9
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, H3A 1A1
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Prairie CardioVascular Research Network
Regina, Saskatchewan, S4P OW5
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria, British Columbia, V8R 4R2

Other trials in Canada

About this study

Official title: 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.

Conditions: AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
Being tested: Freezor Xtra Cryoablation Catheter
Keywords: Cardiac cryoablation, AVNRT, heart disease, tachycardia, AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular tachycardia, SVT
Medical subject headings: Tachycardia, Atrioventricular Nodal Reentry, Tachycardia, Supraventricular, Heart Diseases, Tachycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Freezor Xtra Cryoablation CatheterDevice
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.

Study groups in NCT01426425
Study group	Role	What they receive
Cryoablation	Experimental	Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra. Receives: Device: Freezor Xtra Cryoablation Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
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.
Measured: 6 months
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
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.
Measured: 6 Months

Secondary outcomes (1)

Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.
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.
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Sep 2016

First posted31 Aug 2011 (estimated)
Study startMay 2012
Primary completionSep 2015
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AtrioVentricular Nodal Reentrant TachycardiaStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 572 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01426425
Sponsor's protocol ID: ICY-AVNRT
Status last verified: Feb 2025
First submitted: 29 Aug 2011
Last updated: 13 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wells P, Dubuc M, Klein GJ, Dan D, Roux JF, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA; ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. 2018 Jan;29(1):167-176. doi: 10.1111/jce.13367. Epub 2017 Nov 10.
PubMed 29044787

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia
Supraventricular Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.
Atrioventricular Nodal Reentry Tachycardia, Supraventricular Tachycardia
Not yet recruitingObservational study
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome
Not yet recruiting
Differentiate AVNRT from Orthodromic AVRT
SVT
Enrolling by invitationObservational study
Intracardiac Echocardiography Guided Slow Pathway Cryoablation
Atrioventricular Nodal Reentry Tachycardia

All AtrioVentricular Nodal Reentrant Tachycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)
ClinicalTrials.gov ID: NCT01426425
Acronym / sponsor ID: ICY-AVNRT
Conditions: AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
Keywords: Cardiac cryoablation, AVNRT, heart disease, tachycardia, AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular tachycardia, SVT
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 572 participants (actual)
Lead sponsor: Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Sep 2015 (actual)
Study completion: Sep 2016 (actual)
First posted: 31 Aug 2011 (estimated)
Results: Posted 31 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cryoablation	Experimental	Device: Freezor Xtra Cryoablation CatheterSubjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Freezor Xtra Cryoablation CatheterFreezor® 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.	Device	Cryoablation

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	572	397

Primary outcome: Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.

Time frame: 6 months. Count of participants. Unit: Participants

Measure	mITT Set n = 397
Chronic effectiveness success	368
Chronic effectiveness failure	29

mITT Set: Chronic effectiveness prob at 6 months: 0.926 (95% CI 0.895 to 0.948), p <0.0001, Kaplan-Meier log-log 95% CI

Population analysed: The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	mITT Set n = 397
Chronic safety failure	4
Chronic safety success	393

mITT Set: Safety failure probability at 6 months: 0.01 (95% CI 0.004 to 0.027), p <0.0001, Kaplan-Meier log-log 95% CI

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for each subject from the time of their enrollment through the visit cut-off date for the primary endpoint analyses (September 18, 2015).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mITT Set	30 of 397 (7.6%)	197 of 397 (49.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29044787Wells P, Dubuc M, Klein GJ, Dan D, Roux JF, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA; ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, North American study (ICY-AVNRT STUDY). J Cardiovasc Electrophysiol. 2018 Jan;29(1):167-176. doi: 10.1111/jce.13367. Epub 2017 Nov 10.

Related trials for AtrioVentricular Nodal Reentrant Tachycardia

Recruiting
NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia
Supraventricular Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.
Atrioventricular Nodal Reentry Tachycardia, Supraventricular Tachycardia
Not yet recruitingObservational study
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
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Not yet recruiting
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Enrolling by invitationObservational study
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Atrioventricular Nodal Reentry Tachycardia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Wells, M.D. principal investigator

Baylor Univ Medical Ctr Dallas, TX.

34 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01426425, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.