Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

Atrioventricular Node Arrhythmia Clinical Trial

— Cryo-FP  

Official title:

Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122807
• Other study ID #: 114445
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 2019
• Est. completion date: December 2021

Study information

• Verified date: November 2019
• Source: Lawson Health Research Institute
• Contact: Matthew K Rowe, MBBS
• Phone: 1-519-663-3746
• Email: matthew.rowe[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrioventricular Node Arrhythmia

Intervention

Procedure:
• Cardiac catheter ablation
Cryoablation

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural time		Immediate
Other	Fluoroscopy time		Immediate
Primary	Termination of AVNRT	Number of participants where cryotherapy terminates AVNRT	One day
Secondary	Freedom from recurrence	Number of participants with no recurrence of AVNRT during follow-up	1 year
Secondary	Incidence of AV block	Number of participants where AV block is observed	1 year
Secondary	Cardiac tamponade	Number of participants with pericardial effusion and/or tamponade following procedure	1 year
Secondary	Vascular complications	Number of participants with groin hematoma or fistula requiring intervention following procedure	1 year