Persistent Atrial Fibrillation Ablation and Correlation t... | NCT04290559

Studies
Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life

NCT04290559

Sponsor

Newmarket Electrophysiology Research Group Inc

Status

Unknown status

Last Update Posted

Mar 31, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Reveal LINQ ILR implant before AF 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

Mar 2020

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

Sep 10, 2018Actual

Primary Completion Date

Sep 2021Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Feb 11, 2020

First Submission Date that Met QC Criteria

Feb 26, 2020

First Posted Date

Mar 2, 2020Actual

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

Mar 29, 2020

Last Update Posted Date

Mar 31, 2020Actual

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

The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation.

Detailed Description

Atrial fibrillation (AF) is associated with a higher risk of stroke, heart failure and deterioration in patients' quality of life and it also has great effect on health care resource utilization due to increasing morbidity and mortality. Catheter ablation has shown to improve patients' quality of life (QOL), even in those who undergo a repeat procedure, equalizing healthy population and lowering subsequent health care resource utilization.

Success rates are usually based on an endpoint of total elimination of AF, typically absence of any AF recurrence >30 seconds. While this is a high standard for clinical trial reporting, it does not necessarily measure the "clinical" success, since many patients will experience significant reduction in their AF burden with accompanying improvement in their functional status despite having ongoing brief recurrences of AF.

This is a prospective non-randomized, single-arm, cohort study. 200 patients with persistent atrial fibrillation undergoing catheter ablation will be enroled. AF burden post procedure will be evaluated with continuous monitoring with an implantable loop recorder (ILR) to assess recurrences and AF burden. QOL will be measured using the CCS-SAF severity scale, SF-36 and AFEQT scales pre-ablation and at 12 and 24 months.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reveal LINQ ILR implant before AF ablation	Procedure	Patients will undergo insertion of a LINQ ILR before the atrial fibrillation ablation performed according to standard clinical practice.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AF burden correlated with change in QOL.	AF burden change and absolute AF burden correlated with change in QOL mesured at 12 and 24 months after the AF ablation	12 months, 24 months

Secondary Outcomes

Measure	Description	Time Frame
Freedom of atrial arrhythmia	Freedom of atrial tachycardia/atrial flutter/atrial fibrillation (> 30 sec) at 12 and 24 months after the ablation	12 months, 24 months
Economic evaluation	Change in AF burden correlated with change of health care resource utilization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Patients undergoing first-time or redo AF ablation.
Persistent or long-standing persistent AF
Symptomatic atrial fibrillation
Willing and able to provide informed consent.
Willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored
Atrial fibrillation burden equal or more than 80% prior to the ablation

Exclusion Criteria:

Paroxysmal AF
If the patient has had a cardioversion within 2 months of the ablation
Patients with contraindication to oral or intravenous anticoagulation.
Contraindication to implantation of an ILR

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

Patients with persistent or long-standing persistent atrial fibrillation and an AF burden of equal or more than 80%, referred for an atrial fibrillation catheter ablation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherri Patterson, BScN	Contact	905-895-4521	2149	SPatterson@southlakeregional.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southlake Regional Health Centre	Recruiting	Newmarket	Ontario	L3Y2P9	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

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided