Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

NCT ID: NCT04122807

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Atrioventricular Node Arrhythmia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mapping

Standard treatment involving ablation of the slow pathway with cryotherapy

Group Type ACTIVE_COMPARATOR

Cardiac catheter ablation

Intervention Type PROCEDURE

Cryoablation

Ablation

Mapping and ablation of the retrograde fast pathway with cryotherapy

Group Type EXPERIMENTAL

Cardiac catheter ablation

Intervention Type PROCEDURE

Cryoablation

Interventions

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Cardiac catheter ablation

Cryoablation

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lawson Health Research Institute

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Matthew K Rowe, MBBS

Role: CONTACT

1-519-663-3746

Allan Skanes, MD

Role: CONTACT

1-519-663-3746

Facility Contacts

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Matthew K Rowe, MBBS

Role: primary

1-519-663-3746

Allan Skanes, MD

Role: backup

1-519-663-3746

Other Identifiers

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114445

Identifier Type: -

Identifier Source: org_study_id

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