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Trial registered on ANZCTR

Registration number

ACTRN12619001603101

Ethics application status

Approved

Date submitted

30/10/2019

Date registered

21/11/2019

Date last updated

6/03/2023

Date data sharing statement initially provided

21/11/2019

Date results provided

6/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating the safety and efficacy outcomes of high power and short duration ablation for atrial fibrillation in comparison with current standard of lower power and longer duration ablation

Scientific title

High Power Short Duration (HPSD) versus Lower Power Longer Duration (LPLD) Atrial Fibrillation Ablation in Posterior Left Atrium and Hyperthermic Effects on EsophAgeal Tissue : A Prospective Single Centre Randomised Trial (the Hi-Lo HEAT Study)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

HiLo HEAT Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial fibrillation

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will undergo AF ablation procedure as clinically indicated. This procedure is done under general anaesthesia by an interventional cardiac electrophysiologist. Access will be gained via right femoral vein with 4 sheaths placed. Diagnostic catheters are placed in the Coronary sinus and His bundle. Transesophageal echocardiogram is performed to exclude cardiac thrombus and to guide transseptal puncture. A circular mapping catheter and ablation catheter are placed in the left atrium via long sheaths following transseptal puncture access. The mapping catheter will be used to create a 3D map of the left atrium, which is integrated with pre-procedural CT images of the left atrium. Radiofreqeuency energy is applied using the ablation catheter to create the ablation lesions, with the aim being to perform pulmonary vein isolation. For this study, patients will be randomised to either lower power (25W) when ablating in the posterior wall of the left atrium, or high power ( 40- 50W) Ablation is terminated when target AI of 400 or LSI of 4 is achieved. A multisensor esophageal temperature probe will be used to monitor for luminal temperature rises. The typical duration for an AF ablation is 3 hours, including anaesthetic preparation time.Following the AF ablation, patients will undergo an upper gastrointestinal endoscopy procedure which is done under sedation, to look for any evidence ofesophageal thermal injury. A case report form will be used to record all intraprocedural details from the AF ablation and also findings from the post ablation endoscopy. Brain MRI will be performed day 1 following ablation to look for silent cerebral infarctions (SCIs). All patients will be followed up for 12 months after their ablation procedure. Anticoagulation is continued for at least 3 months after ablation, with cessation beyond that as per clinician decision. Anti-arrhythmic medications will be discontinued after ablation in paroxysmal AF patients, and at 3 months after ablation in persistent AF patients. Patients will be reviewed in the arrhythmia clinic at 3 and 12 months. Heart rhythm monitoring is performed either via AliveCor® electronic rhythm monitoring system, or 24 Hr holters. Follow-up 24-day holter monitoring will be performed at 3,6, 9 and 12 months. Patients will be requested to complete the AFEQT questionnaire at 6 months and 12 months

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Lower power longer duration ablation

Control group

Active

Outcomes

Primary outcome [1]

Esophageal thermal injury

Timepoint [1]

24 hours following intervention through routine post ablation endoscopy

Primary outcome [2]

Significant intraluminal temperature rise during ablation, defined as :
o Number of temperature spikes more than or equal to 39ºC
o Number of steep temperature rises of more than 0.5 -1 degrees within 5 seconds
o Number of steep temperature rises of more than 1 degrees within 5 seconds
o Cumulative amount of time in which temperature was more than or equal to 38ºC

Intraluminal temperature is measured using a multisensor temperature probe ( S -Cath, Circa Scientific) placed in the esophagus

Timepoint [2]

Intraprocedural

Secondary outcome [1]

Radiofrequency energy amount, which is derived from the ablation console (NAVx or CARTO)

Timepoint [1]

Immediately after

Secondary outcome [2]

First pass pulmonary vein isolation (PVI) rate , with or without posterior wall isolation (PWI) rate. This is measured using the mapping catheter used intraprocedurally which is placed into the pulmonary vein / onto the posterior wall

Timepoint [2]

Intraprocedure

Secondary outcome [3]

Acute procedural complications which include:
-cardiac perforation / tamponade which is assessed on clinical examination and confirmed on echocardiogram
-stroke, which is assessed on clinical examination and confirmed on brain imaging
- groin complication, which includes bleeding, bruising, and vascular damage. This is assessed on clinical examination and confirmed on leg ultrasound

Delayed procedural complication, which include
- Pulmonary vein stenosis - this is assessed based on participant reported symptom of breathlessness and confirmed on CT venogram
-Atrioesophageal fistula - this is assessed based on participant reported symptom of dysphagia/ odynophagia, physical examination looking for fevers , and confirmed on CT scan of the chest

Timepoint [3]

Intraprocedure to 12 months follow up
Patients are reviewed in the arrhythmia clinic at routinely at 3 months and 12 months. Additional clinical review within this time frame will be as per treating clinician discretion

Secondary outcome [4]

Single radiofrequency (RF) ablation procedure success rate off anti-arrhythmic drugs at 12 months. Participants will have their rhythm monitored to look for any atrial arrhythmia (including atrial fibrillation) recurrence using either 3 monthly 24 holter monitors or the Alive Cor cardiac monitoring device (where patients will send their ECGs daily). Patients will also have their ECGs recorded durng their clinical follow ups.

Timepoint [4]

12 months post ablation

Secondary outcome [5]

Procedural duration time. This will be based on the stated start and end times on the medical records

Timepoint [5]

Immediately after procedure

Secondary outcome [6]

Fluoroscopy time, which is derived from the Phillips X ray interventional system in the cathlab

Timepoint [6]

Immediately after procedure

Secondary outcome [7]

Radiofrequency energy time, which is derived from the ablation console (NAVx or CARTO)

Timepoint [7]

Immediately after

Secondary outcome [8]

Effects of ablation on the quality of life of participants will be assessed using the AFEQT questionnaire

Timepoint [8]

6 and 12 months after the ablation

Secondary outcome [9]

Incidence of silent cerebral infarction as detected on brain MRI

Timepoint [9]

Day 1 post ablation

Eligibility

Key inclusion criteria

1. Patients aged more than / equal to 18 years old
2. Patients undergoing a first-time ablation procedure for AF
3. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication
4. Patients must be able and willing to provide written informed consent to participate in this investigation
5. Patients must be willing and able to comply with all peri-ablation and follow- up requirements

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients with long-standing persistent AF - defined as a sustained episode lasting more than 3 years
2. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
3. Patients with AF felt to be secondary to an obvious reversible cause
4. Left atrium thrombus
5. Previous AF ablation
6. Severe valvular heart disease
7. Known esophageal disorder / GORD
8. Patients with contraindications for taking anticoagulation therapy
9. Patients with creatinine >200 ml/min or end stage renal / liver impairment
10. Pregnancy
11. Diagnosis of hypertrophic cardiomyopathy.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

This study is designed to demonstrate superiority against standard lower power longer duration RF ablation. A recent meta-analysis had reported the rate of endoscopically detected esophageal lesion between 2.2- 21% (pooled prevalence of 11% ) with posterior wall ablation performed at a range of 10W to 35 W (25). Given the recent findings of ETI at 2.5% in a HPSD cohort, the minimum sample size needed per treatment arm would be 44 patients. Assuming no patient drop out for the primary endpoint, the final sample size required is 88 patients

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2020

Actual

18/06/2020

Date of last participant enrolment

Anticipated

31/12/2021

Actual

24/05/2021

Date of last data collection

Anticipated

24/05/2022

Actual

24/05/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment hospital [2]

Cabrini Hospital - Malvern - Malvern

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3144 - Malvern

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Professor Peter Kistler

Address [1]

Alfred Health
55 Commercial Road
Melbourne 3004 Victoria

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Cardiology Department, Alfred Hospital

Address [2]

55 Commercial Road, Melbourne 3004 Victoria

Country [2]

Australia

Primary sponsor type

Hospital

Name

Alfred Health

Address

55 Commercial Road, Melbourne 3004 Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Ethics and Research Governance Committee

Ethics committee address [1]

55 Commercial Road, Melbourne 3004 Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2019

Approval date [1]

13/10/2019

Ethics approval number [1]

Summary

Brief summary

Catheter based atrial fibrillation (AF) ablation is an effective treatment option for AF patients who are intolerant or who do not respond to medications. Ablation using radiofrequency energy in the back wall (posterior wall)  of the left atrium is associated with a risk of causing esophageal thermal injury (ETI). Current strategies to minimise the risk of ETI include reducing the ablation power setting to 25 Watts and using an esophageal temperature probe. Recent studies have shown that the use of high power (50 Watts) but shorter duration (HPSD) ablation results in more effective AF lesion formation with no increase in complication rates, including rates of ETI. This single center randomised trial is designed to compare HPSD ablation to standard lower power longer duration (LPLD) ablation and the effects on ETI rates. Patients with paroxysmal or persistent AF undergoing their first AF ablation procedure at the Alfred Hospital will be recruited and randomised into the 2 treatment arms. A multisensor esophageal temperature probe will be used in all cases. All participants will undergo an endoscopy within 24 hours after their ablation to look for evidence of ETI, with 12 months of follow up after. We expect the study to show that HPSD ablation is non- inferior to LPLD ablation in terms of ETI, with significantly lower procedural times and exposure to radation

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Peter Kistler

Address

Alfred Health
55 Commercial Road, Melbourne 3004 Victoria

Country

Australia

Phone

+61 03 90762000

Fax

[email protected]

Contact person for public queries

Name

David Chieng

Address

Alfred Health
55 Commercial Road, Melbourne 3004 Victoria

Country

Australia

Phone

+61 0390762000

Fax

[email protected]

Contact person for scientific queries

Name

David Chieng

Address

Alfred Health
55 Commercial Road, Melbourne 3004 Victoria

Country

Australia

Phone

+61 0390762000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

deidentified patient data which are directly related to the published results will be shared on reasonable request

When will data be available (start and end dates)?

data will be available 1 year post trial completion (May 2023) and for 6 months only

Available to whom?

data is available to medical institutions with reasonable request made to the CPI of trial

Available for what types of analyses?

data will be available for statistical analyses of trial data

How or where can data be obtained?

the data will be made available to reputable healthcare institutions/ research institutes involved in atrial fibrillation research on reasonable request to the CPI. The CPI shall be contacted formally using secure work email address [email protected]. Upon agreement to share information the data will be tranferred via suitable and secure electronic transfer arrangements

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5495	Informed consent form					378646-(Uploaded-23-10-2020-22-16-50)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Higher power short duration vs. lower power longer duration posterior wall ablation for atrial fibrillation and oesophageal injury outcomes: a prospective multi-centre randomized controlled study (Hi-Lo HEAT trial).	2023	https://dx.doi.org/10.1093/europace/euac190

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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