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Apple Watch-led Surveillance of AF Recurrence After Catheter Ablation (AFFU-AW)

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Apple Watch-based heart rhythm monitoring

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring atrial fibrillation, wearable

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Referred for first AFCA procedure by a Consultant electrophysiologist.
Paroxysmal or persistent AF captured on ECG but not in continuous AF for more than 3 years. (Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days of onset. Persistent AF will be defined as any continuous episode lasting longer than 7 days or requiring intervention to restore sinus rhythm after this time.)
At least one episode of AF must have been documented by ECG or Holter within 12 months of inclusion in the study.
Continuous anticoagulation with warfarin (INR 2-3), low molecular weight heparin, or a novel oral anticoagulant (dabigatran, apixaban, rivaroxaban, edoxaban) for ≥4 weeks prior to the ablation; or a TEE that excludes LA thrombus ≤48 hours before ablation.
Access to a smartphone with Apple-operating system (OS) within their household for syncing with their watch.
Participants must be able and willing to provide written informed consent

Exclusion Criteria:

Patients with permanent AF. Permanent AF is defined as chronic, persisting AF (typically more than 1 year) for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
Patients with AF felt to be secondary to an obvious reversible cause.
Patients who are, or may potentially be pregnant.
Any cardiac implantable electronic device in situ or expected to undergo implantation in the next 12 months.
Previous left atrial (LA) ablation or LA surgery
Pre-existing pulmonary vein stenosis or PV stent
Pre-existing hemi-diaphragmatic paralysis
Contraindication to anticoagulation or radiocontrast materials
Acute coronary syndrome within 4 weeks as defined by ECG ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent).
Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrolment.
Life expectancy less than 1 year

Sites / Locations

St Bartholomew's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Active

Control

Arm Description

Participants shall receive standard care and follow-up as provided by their clinical care provider. Heart rhythm monitoring tests shall be performed as per their clinical care provider. In addition, participants in this arm shall be loaned an Apple Watch device and undergo an education session to familiarise themselves with the study recording schedule and how to perform recordings.

Participants shall receive standard care and follow-up as provided by their clinical care provider. Heart rhythm monitoring tests shall be performed as per their clinical care provider.

Outcomes

Primary Outcome Measures

Time to first documented recurrence of AF/AFl/AT

Secondary Outcome Measures

Time to first documented recurrence of symptomatic AF/AFl/AT

Freedom from AF and re-do AF CA procedures per patient at the 12 month timepoint.

The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months.

Using the Atrial Fibrillation Quality of Life (AFeQT) survey. Min=20, Max=140. Higher score= worse outcome

The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months.

Using the Barts Atrial Fibrillation Patient Reported Outcome Measure survey. Min=28, Max=140. Higher score= worse outcome

Full Information

NCT ID

NCT05016791

First Posted

July 16, 2021

Last Updated

August 14, 2023

Sponsor

Barts & The London NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT05016791

Brief Title

Apple Watch-led Surveillance of AF Recurrence After Catheter Ablation

Acronym

AFFU-AW

Official Title

Evaluating the Impact of Prolonged, Patient-led Heart Rhythm Surveillance With the Apple Watch on Detecting Arrhythmia Recurrence and Decision-making After Catheter Ablation of Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Barts & The London NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Atrial fibrillation (AF) is a heart rhythm disorder associated with debillitating symptoms, psychological distress and heart failure. It can also significantly increase an individuals stroke risk. Catheter ablation (CA) for AF is the most effective way to restore normal heart rhythm. However, AF can recur in up to 50% of patients after their first CA procedure and a second 'top-up' procedure may be needed to maximise effect. Early detection of recurrences can enable planning and treatment and repeat CA procedures. Post-CA follow-up strategies rely on episodic rhythm monitoring (Holter monitor tests) that usually last between 1 and 7 days. However, AF recurrences can be intermittent and may not occur during these short monitoring episodes. A greater duration of monitoring has been shown to yield greater detection of AF recurrences. Relying on symptoms alone to detect recurrence is also sub-optimal. AF recurrences can also be insidious. Similar symptoms may be reported from ectopy, atrial tachycardias or atrial flutter. These may require different management approaches, necessitating rhythm characterisation before considering a repeat CA. The Apple Watch (AW) is a wristwatch that is able to monitor a wearer's heart rate and rhythm regularity as well as facilitating an immediate, real-time single-lead ECG recording. This non-invasive device that can be purchased over- the-counter has demonstrated feasibility in detecting AF and may offer a potential non-invasive, alternative long-term rhythm surveillance strategy to diagnose AF in these patients. The investigators propose a single-centre, randomised controlled study to compare the standard follow-up strategy after index AF CA versus one supplemented with an AW-led prolonged monitoring strategy to determine if the latter will improve the expediency and rate of AF recurrence detection. Whether this will lead to improved downstream decision-making, reduction in symptomatic events and a lower prevalence of AF in the longer term will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

atrial fibrillation, wearable

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A prospective, randomised controlled trial to compare the standard follow-up pathway after AF catheter ablation against the standard pathway augmented with Apple Watch-based rhythm monitoring. The endpoints will be the time to detection of AF recurrence and downstream sequelae such as the number of repeat ablation procedures, and longer-term freedom from AF.

Masking

None (Open Label)

Masking Description

Participants will be randomised after enrollment to active or control arms of this study

Allocation

Randomized

Enrollment

172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants shall receive standard care and follow-up as provided by their clinical care provider. Heart rhythm monitoring tests shall be performed as per their clinical care provider.

Intervention Type

Device

Intervention Name(s)

Apple Watch-based heart rhythm monitoring

Intervention Description

For the duration of the study, participants in the active arm will be asked to make ECG recordings in three circumstances: Routinely once per day from the day of randomisation till the 12-month visit after AF CA (they will be encouraged to do so at the same time each day with the option to set a reminder on the watch). If the AW requests them to do so (the automatic AF-notification algorithm will be active throughout the study period and if AF is suspected based on the tachogram, it will trigger notification for the participant to make an ECG recording). This will be till the 12-month time point. If the patient has symptoms of palpitations, pre-syncope or syncope. This will be till the 12-month time point. Monitoring should continue even if AF has been diagnosed to characterise arrhythmia burden and profile. Participants will be given the contact details of a dedicated email inbox to which to send ECGs recorded through the AW.

Primary Outcome Measure Information:

Title

Time to first documented recurrence of AF/AFl/AT

Time Frame

between days 91 to 365 after ablation

Secondary Outcome Measure Information:

Title

Time to first documented recurrence of symptomatic AF/AFl/AT

Time Frame

between days 91 and 365 after ablation

Title

Freedom from AF and re-do AF CA procedures per patient at the 12 month timepoint.

Time Frame

1 year

Title

The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months.

Description

Using the Atrial Fibrillation Quality of Life (AFeQT) survey. Min=20, Max=140. Higher score= worse outcome

Time Frame

1 year

Title

The relative patient-reported satisfaction score in the active arm of the study compared to the control arm at 12 months.

Description

Using the Barts Atrial Fibrillation Patient Reported Outcome Measure survey. Min=28, Max=140. Higher score= worse outcome

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Correlation between the atrial tachyarrhythmia burden during the blanking period (day 0 to day 90 post ablation) and documented recurrence of AF/AFl/AT after the blanking period ( day 91 to day 365 after ablation).

Description

active arm of the study only

Time Frame

1 year

Title

Per-subject comparison of accelerometer-derived activity levels during sinus rhythm as compared to atrial arrhythmia in patients who have a paroxysmal atrial arrhythmia recurrence

Description

active arm of the study only

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Referred for first AFCA procedure by a Consultant electrophysiologist. Paroxysmal or persistent AF captured on ECG but not in continuous AF for more than 3 years. (Paroxysmal AF is defined as an episode of AF that terminates spontaneously or with intervention within 7 days of onset. Persistent AF will be defined as any continuous episode lasting longer than 7 days or requiring intervention to restore sinus rhythm after this time.) At least one episode of AF must have been documented by ECG or Holter within 12 months of inclusion in the study. Continuous anticoagulation with warfarin (INR 2-3), low molecular weight heparin, or a novel oral anticoagulant (dabigatran, apixaban, rivaroxaban, edoxaban) for ≥4 weeks prior to the ablation; or a TEE that excludes LA thrombus ≤48 hours before ablation. Access to a smartphone with Apple-operating system (OS) within their household for syncing with their watch. Participants must be able and willing to provide written informed consent Exclusion Criteria: Patients with permanent AF. Permanent AF is defined as chronic, persisting AF (typically more than 1 year) for which cardioversion (pharmacologic or electrical) has failed or will never be attempted. Patients with AF felt to be secondary to an obvious reversible cause. Patients who are, or may potentially be pregnant. Any cardiac implantable electronic device in situ or expected to undergo implantation in the next 12 months. Previous left atrial (LA) ablation or LA surgery Pre-existing pulmonary vein stenosis or PV stent Pre-existing hemi-diaphragmatic paralysis Contraindication to anticoagulation or radiocontrast materials Acute coronary syndrome within 4 weeks as defined by ECG ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent). Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrolment. Life expectancy less than 1 year

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Richard Schilling

Phone

02037658635

richard.schilling@nhs.net

First Name & Middle Initial & Last Name or Official Title & Degree

Nikhil Ahluwalia

Phone

02037658635

nikhil.ahluwalia@nhs.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Schilling

Organizational Affiliation

Barts & The London NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Bartholomew's Hospital

City

City Of London

State/Province

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Schilling

Phone

02037658635

richard.schilling@nhs.net

First Name & Middle Initial & Last Name & Degree

Nikhil Ahluwalia

Phone

02037658635

nikhil.ahluwalia@nhs.net

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Apple Watch-led Surveillance of AF Recurrence After Catheter Ablation

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