Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT (Cryo-FP)

Lawson Health Research Institute

Status and phase: Unknown; Early Phase 1

Conditions: Atrioventricular Node Arrhythmia

Treatments: Procedure: Cardiac catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04122807

114445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Mapping

Active Comparator group

Description:

Standard treatment involving ablation of the slow pathway with cryotherapy

Treatment:

Procedure: Cardiac catheter ablation

Ablation

Experimental group

Description:

Mapping and ablation of the retrograde fast pathway with cryotherapy

Treatment:

Procedure: Cardiac catheter ablation