Atrioventricular Nodal Ablation Versus Pulmonary Vein Iso... | NCT07059208

Studies
Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions

NCT07059208

Sponsor

Sunshine Coast Hospital and Health Service

Status

Not yet recruiting

Last Update Posted

Jul 14, 2025Actual

Enrollment

172Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation (AF)

Interventions

Atrioventricular nodal ablation
Pulmonary vein isolation

Countries

Not provided

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2025Estimated

Primary Completion Date

Sep 2029Estimated

Completion Date

Sep 2031Estimated

First Submitted Date

Jul 1, 2025

First Submission Date that Met QC Criteria

Jul 1, 2025

First Posted Date

Jul 10, 2025Actual

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

Jul 9, 2025

Last Update Posted Date

Jul 14, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew Tung, Principal Investigator, Sunshine Coast Hospital and Health ServicePrincipal Investigator

Lead Sponsor

Sunshine Coast Hospital and Health ServiceOTHER

Collaborators

Not provided

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 goal of this clinical trial is to compare two procedural approaches to managing atrial fibrillation. The main questions it aims to answer are:

Is AF ablation or pacemaker implant and AV nodal ablation a more effective treatment approach for patients with atrial fibrillation refractory to pharmacological treatment?

What effect do these differing treatment approaches have on patient's quality of life and mental health?

Participants will:

Be randomly allocated to one of the treatment approaches. Visit the clinic 2 months, 12 months and 24 months after their procedure for a checkup, questionnaires and repeat heart ultrasounds.

Detailed Description

The goal of this trial is to compare the effectiveness and safety of pulmonary vein isolation compared with pacemaker implant and atrioventricular nodal ablation for patients with atrial fibrillation.

Patients who have been refractory to attempts at symptom control with pharmacological therapy will be eligible and will be randomised to one of the two approaches.

The primary outcome will be all cause rehospitalisation with secondary outcomes including procedural complications, echocardiographic measurements, patient reported outcomes, all cause mortality and rehospitalisation due to cardiovascular causes. These will be assessed over the 2 years following the index procedure.

The patient reported outcome measures will be the EQ5D, AF Effect on Quality of life score (AFEQT), Hospital anxiety and depression score (HADS) and Somatosensory amplification scale.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

172Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary vein isolation	Active Comparator	Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation	Procedure: Pulmonary vein isolation
Pacemaker implant and atrioventricular nodal ablation	Active Comparator	Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation	Procedure: Atrioventricular nodal ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atrioventricular nodal ablation	Procedure	Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation	Pacemaker implant and atrioventricular nodal ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause rehospitalisation	All rehospitalisations for any reason will be included	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 65 years for patients with persistent atrial fibrillation or greater than 75 years for patients with paroxysmal atrial fibrillation.
Unsuccessful trial of at least one pharmacological rate or rhythm control medication. This includes patients with medication refractory AF and/or intolerance to the medication(s).
A resting ECG demonstrating AF with ventricular response rate >70bpm on a pharmacological rate control medication, or >90bpm while not on rate control medication.

Exclusion Criteria:

Previous pulmomary vein isolation, left atrial flutter ablation or atrioventricular node ablation.
BMI >40.
Not suitable for pulmonary vein isolation and/or pacemaker implant on clinical grounds.

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 Tung, MBBS	Contact	+61752020000		matthew.tung@health.qld.gov.au

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All deidentified data will be shared with any potential research collaborators

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

1 Oct 2025 to 1 Oct 2035

Access Criteria

Accessible by contact person listed

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