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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122807
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Atrioventricular Node Arrhythmia Procedure: Cardiac catheter ablation Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective model with two groups based on PR interval on ECG, normal and prolonged PR
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Termination of AVNRT [ Time Frame: One day ]
    Number of participants where cryotherapy terminates AVNRT


Secondary Outcome Measures :
  1. Freedom from recurrence [ Time Frame: 1 year ]
    Number of participants with no recurrence of AVNRT during follow-up

  2. Incidence of AV block [ Time Frame: 1 year ]
    Number of participants where AV block is observed

  3. Cardiac tamponade [ Time Frame: 1 year ]
    Number of participants with pericardial effusion and/or tamponade following procedure

  4. Vascular complications [ Time Frame: 1 year ]
    Number of participants with groin hematoma or fistula requiring intervention following procedure


Other Outcome Measures:
  1. Procedural time [ Time Frame: Immediate ]
  2. Fluoroscopy time [ Time Frame: Immediate ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122807


Contacts
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Contact: Matthew K Rowe, MBBS 1-519-663-3746 matthew.rowe@lhsc.on.ca
Contact: Allan Skanes, MD 1-519-663-3746 allan.skanes@lhsc.on.ca

Locations
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Canada, Ontario
Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A5A5
Contact: Matthew K Rowe, MBBS    1-519-663-3746    matthew.rowe@lhsc.on.ca   
Contact: Allan Skanes, MD    1-519-663-3746    allan.skanes@lhsc.on.ca   
Principal Investigator: Allan Skanes, MD         
Sub-Investigator: Matthew K Rowe, MBBS         
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04122807    
Other Study ID Numbers: 114445
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
AVNRT
Cryoablation
PR interval