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Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04122807
Acronym
Cryo-FP
Enrollment
20
Registered
2019-10-10
Start date
2019-11-30
Completion date
2021-12-31
Last updated
2019-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular Node Arrhythmia

Keywords

AVNRT, Cryoablation, PR interval

Brief summary

In this study a new technique for ablation in atrioventricular nodal reentrant tachycardia using cryo-energy will be studied in cases where the standard approach has higher risk.

Detailed description

Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common cause of fast heartbeats in young people. People with AVNRT have two pathways within the heart, the fast pathway (FP) and slow pathway (SP). A treatment for AVNRT is ablation (burning or freezing) of the SP. This can be done with either radiofrequency or cryo-energy. A complication which occurs in 1% of cases is AV block (AVB), meaning the person needs a pacemaker. Slow pathway ablation is a problem in people when the electrocardiogram (ECG) shows a long PR interval, with greater rates of AVB. This accounts for 5% of AVNRT cases. A possible solution is to treat the FP with cryo-energy and leave the SP intact. This pilot study aims to show this is safe and effective.

Interventions

PROCEDURECardiac catheter ablation

Cryoablation

Sponsors

University of Western Ontario, Canada
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective model with two groups based on PR interval on ECG, normal and prolonged PR

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Documented supraventricular tachycardia (SVT) * Planned to undergo electrophysiology (EP) study and ablation * PR interval on ECG \<220ms (Group 1) or \>220ms (Group 2)

Exclusion criteria

* Pregnancy * Age \<18 years * Inability to provide consent * High likelihood of tachycardia mechanism other than AVNRT (e.g. Pre-excitation on surface ECG, atrial tachycardia)

Design outcomes

Primary

MeasureTime frameDescription
Termination of AVNRTOne dayNumber of participants where cryotherapy terminates AVNRT

Secondary

MeasureTime frameDescription
Freedom from recurrence1 yearNumber of participants with no recurrence of AVNRT during follow-up
Incidence of AV block1 yearNumber of participants where AV block is observed
Cardiac tamponade1 yearNumber of participants with pericardial effusion and/or tamponade following procedure
Vascular complications1 yearNumber of participants with groin hematoma or fistula requiring intervention following procedure

Other

MeasureTime frame
Procedural timeImmediate
Fluoroscopy timeImmediate

Countries

Canada

Contacts

Primary ContactMatthew K Rowe, MBBS
matthew.rowe@lhsc.on.ca1-519-663-3746
Backup ContactAllan Skanes, MD
allan.skanes@lhsc.on.ca1-519-663-3746

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026