Cryoablation of the Retrograde Fast Pathway as Treatment... | NCT04122807

Studies
Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

NCT04122807

Sponsor

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

Status

Unknown status

Last Update Posted

Nov 20, 2019Actual

Enrollment

20Estimated

Phase

Early Phase 1

Conditions

Atrioventricular Node Arrhythmia

Interventions

Cardiac catheter ablation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2019Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Oct 2, 2019

First Submission Date that Met QC Criteria

Oct 9, 2019

First Posted Date

Oct 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2019

Last Update Posted Date

Nov 20, 2019Actual

Name	Class
University of Western Ontario, Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mapping	Active Comparator	Standard treatment involving ablation of the slow pathway with cryotherapy	Procedure: Cardiac catheter ablation
Ablation	Experimental	Mapping and ablation of the retrograde fast pathway with cryotherapy	Procedure: Cardiac catheter ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac catheter ablation	Procedure	Cryoablation	Ablation Mapping

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Freedom from recurrence	Number of participants with no recurrence of AVNRT during follow-up	1 year
Incidence of AV block	Number of participants where AV block is observed

Other Outcomes

Measure	Description	Time Frame
Procedural time		Immediate
Fluoroscopy time		Immediate

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew K Rowe, MBBS	Contact	1-519-663-3746		matthew.rowe@lhsc.on.ca
Allan Skanes, MD	Contact	1-519-663-3746		allan.skanes@lhsc.on.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lawson Health Research Institute	Recruiting	London	Ontario	N6A5A5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

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Browse Branches

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