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

November 18, 2019 updated by: Lawson Health Research Institute
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Recruiting
        • Lawson Health Research Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Matthew K Rowe, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mapping
Standard treatment involving ablation of the slow pathway with cryotherapy
Procedure: Cardiac catheter ablation
Cryoablation
Experimental: Ablation
Mapping and ablation of the retrograde fast pathway with cryotherapy
Procedure: Cardiac catheter ablation
Cryoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Termination of AVNRT
Time Frame: One day
Number of participants where cryotherapy terminates AVNRT
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from recurrence
Time Frame: 1 year
Number of participants with no recurrence of AVNRT during follow-up
1 year
Incidence of AV block
Time Frame: 1 year
Number of participants where AV block is observed
1 year
Cardiac tamponade
Time Frame: 1 year
Number of participants with pericardial effusion and/or tamponade following procedure
1 year
Vascular complications
Time Frame: 1 year
Number of participants with groin hematoma or fistula requiring intervention following procedure
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Procedural time
Time Frame: Immediate
Immediate
Fluoroscopy time
Time Frame: Immediate
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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