← Back to Search

Cryoablation

Cryoablation for AVNRT

Phase 3
Waitlist Available
Led By Peter Wells, M.D.
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor Pre-Electrophysiology Study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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.

Eligible Conditions
  • Cardiovascular Disease
  • AVNRT
  • Supraventricular Tachycardia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.
Secondary study objectives
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.

Side effects data

From 2016 Phase 3 trial • 572 Patients • NCT01426425
11%
Palpitations
6%
Supraventricular tachycardia
5%
Chest pain
3%
Bundle branch block right
2%
Musculoskeletal pain
2%
Arthralgia
2%
Atrial fibrillation
2%
Atrioventricular block first degree
2%
Anxiety
2%
Dyspnoea
2%
Urinary tract infection
2%
Headache
2%
Chest discomfort
2%
Pain in extremity
2%
Bronchitis
2%
Upper respiratory tract infection
2%
Sinus tachycardia
2%
Groin pain
2%
Tachycardia
1%
Pain
1%
Pharyngitis
1%
Pyelonephritis
1%
Ligament sprain
1%
Pulmonary embolism
1%
Hypothyroidism
1%
Uterine leiomyoma
1%
Constipation
1%
Crohn's disease
1%
Haemorrhoids
1%
Acute sinusitis
1%
Blood pressure increased
1%
Atrial tachycardia
1%
Pharyngitis streptococcal
1%
Gastrooesophageal reflux disease
1%
Fatigue
1%
Nasopharyngitis
1%
Pneumonia
1%
Sinusitis
1%
Fibromyalgia
1%
Myalgia
1%
Dysuria
1%
Diarrhoea
1%
Haematoma
1%
Rectal haemorrhage
1%
Influenza
1%
Contusion
1%
Back pain
1%
Carpal tunnel syndrome
1%
Dizziness
1%
Depression
1%
Chronic obstructive pulmonary disease
1%
Heart rate increased
1%
Migraine
1%
Rhinitis allergic
1%
Dyspnoea exertional
1%
Hypertension
1%
Vertigo
1%
Oedema peripheral
1%
Non-cardiac chest pain
1%
Dyspepsia
1%
Gastritis
1%
Fall
1%
Laceration
1%
Adverse drug reaction
1%
Gastroenteritis
1%
Tendonitis
1%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
mITT Set

Trial Design

1Treatment groups
Experimental Treatment
Group I: CryoablationExperimental Treatment1 Intervention
Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Freezor Xtra Cryoablation Catheter
2012
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
202 Previous Clinical Trials
135,440 Total Patients Enrolled
Peter Wells, M.D.Principal InvestigatorBaylor Univ Medical Ctr Dallas, TX.
~43 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top