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

Primary Purpose

Atrioventricular Node Arrhythmia

Status
Unknown status
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cardiac catheter ablation
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Node Arrhythmia focused on measuring AVNRT, Cryoablation, PR interval

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Lawson Health Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mapping

Ablation

Arm Description

Standard treatment involving ablation of the slow pathway with cryotherapy

Mapping and ablation of the retrograde fast pathway with cryotherapy

Outcomes

Primary Outcome Measures

Termination of AVNRT
Number of participants where cryotherapy terminates AVNRT

Secondary Outcome Measures

Freedom from recurrence
Number of participants with no recurrence of AVNRT during follow-up
Incidence of AV block
Number of participants where AV block is observed
Cardiac tamponade
Number of participants with pericardial effusion and/or tamponade following procedure
Vascular complications
Number of participants with groin hematoma or fistula requiring intervention following procedure

Full Information

First Posted
October 2, 2019
Last Updated
November 18, 2019
Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04122807
Brief Title
Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT
Acronym
Cryo-FP
Official Title
Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Node Arrhythmia
Keywords
AVNRT, Cryoablation, PR interval

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Prospective model with two groups based on PR interval on ECG, normal and prolonged PR
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mapping
Arm Type
Active Comparator
Arm Description
Standard treatment involving ablation of the slow pathway with cryotherapy
Arm Title
Ablation
Arm Type
Experimental
Arm Description
Mapping and ablation of the retrograde fast pathway with cryotherapy
Intervention Type
Procedure
Intervention Name(s)
Cardiac catheter ablation
Intervention Description
Cryoablation
Primary Outcome Measure Information:
Title
Termination of AVNRT
Description
Number of participants where cryotherapy terminates AVNRT
Time Frame
One day
Secondary Outcome Measure Information:
Title
Freedom from recurrence
Description
Number of participants with no recurrence of AVNRT during follow-up
Time Frame
1 year
Title
Incidence of AV block
Description
Number of participants where AV block is observed
Time Frame
1 year
Title
Cardiac tamponade
Description
Number of participants with pericardial effusion and/or tamponade following procedure
Time Frame
1 year
Title
Vascular complications
Description
Number of participants with groin hematoma or fistula requiring intervention following procedure
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Procedural time
Time Frame
Immediate
Title
Fluoroscopy time
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew K Rowe, MBBS
Phone
1-519-663-3746
Email
matthew.rowe@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Skanes, MD
Phone
1-519-663-3746
Email
allan.skanes@lhsc.on.ca
Facility Information:
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew K Rowe, MBBS
Phone
1-519-663-3746
Email
matthew.rowe@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Allan Skanes, MD
Phone
1-519-663-3746
Email
allan.skanes@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Allan Skanes, MD
First Name & Middle Initial & Last Name & Degree
Matthew K Rowe, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

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