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Trial registered on ANZCTR


Registration number
ACTRN12625000389404
Ethics application status
Approved
Date submitted
13/04/2025
Date registered
1/05/2025
Date last updated
1/05/2025
Date data sharing statement initially provided
1/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing temperature change during ablation with a temperature sensing probe
Scientific title
Assessing thermal energy conduction distant to the site of catheter ablation: a CLInical trial of a teMperATurE sensing diagnostic electrophysiology catheter
Secondary ID [1] 313620 0
None
Universal Trial Number (UTN)
U1111-1317-2085
Trial acronym
CLIMATE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial flutter 336173 0
atrial fibrillation 336172 0
supraventricular tachycardia 336171 0
atrioventricular nodal reentrant tachycardia 337212 0
Condition category
Condition code
Cardiovascular 332716 332716 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Temperature sensing and monitoring of the atrioventricular node using the QDOT MICRO™ catheter (Biosense and Webster, Inc, Irvine, CA). This intervention will replace the standard His Bundle catheter at the His Bundle position (surrogate marker of the atrioventricular node) during cardiac ablation procedures for temperature recording (note: it will not be used for ablation). Recruitment of 2 groups of patients undergoing either atrioventricular node ablation or supraventricular tachycardia ablation with 20 patients in each where temperature monitoring will occur in both groups.

In Group 1, participants will be undergoing clinically-indicated atrioventricular node ablation with permanent pacemakers already in-situ. In Group 2, participants undergoing clinically-indicated supraventricular tachycardia ablations will be consented but only recruited if they have peri-nodal pathways (e.g. atrioventricular nodal re-entrant tachycardia). For both groups, standard electrophysiology study set-up will occur with a decapolar diagnostic electrophysiology catheter in the coronary sinus. Instead of the standard diagnostic electrophysiology catheter placed at the His Bundle location, this will be replaced by the QDOT MICRO™ to measure temperature during ablation. Participants would not receive access to the QDOT MICRO™ if they are not enrolled in the study. A standard mapping system using CARTO3 (Biosense Webster) and intracardiac electrogram analysis system using WorkMate Claris™ (Abbott) will be used. The ablation catheter used will be as per physician discretion and power administration will be standard settings for irrigated (25-35W) or non-irrigated (50W) ablation.

During each ablation lesion, temperature recorded by the QDOT MICRO™ at the His Bundle will be correlated to electrophysiology measurements (junctional speeding or atrioventricular block for Group 1) and distance from ablation catheter to His Bundle until the procedure is completed. Operators will be blinded to the temperature at the atrioventricular node. Adherence assessment is not required as this is a same day procedure. The procedures will be performed by cardiac electrophysiologists in a cardiac catheterisation laboratory with vast experience in these procedures. The procedure duration will take a similar time to usual practiceas the only major change is replacing the His catheter; for Group 1 this is approximately 30-60 minutes and for Group 2 this will take around 60-120 minutes. Participants will be followed-up at 3 months as per routine clinical care with review of symptoms and ECG.

Materials: baseline and 3-month follow-up
1. Short-Form 36 questionnaire (for general quality of life assessment)
https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf
Intervention code [1] 330888 0
Prevention
Intervention code [2] 330774 0
Early detection / Screening
Intervention code [3] 330660 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341061 0
Temperature change at the atrioventricular node during and post ablation
Timepoint [1] 341061 0
At time of procedure
Secondary outcome [1] 446751 0
Association of temperature change at atrioventricular node with QRS interval
Timepoint [1] 446751 0
At time of procedure
Secondary outcome [2] 446748 0
Association of temperature change at atrioventricular node with AH interval
Timepoint [2] 446748 0
At time of procedure
Secondary outcome [3] 446750 0
Association of temperature change at atrioventricular node with PR interval
Timepoint [3] 446750 0
At time of procedure
Secondary outcome [4] 445997 0
Association of temperature change at atrioventricular node with distance between ablation catheter and temperature sensing catheter recording temperature
Timepoint [4] 445997 0
At time of procedure
Secondary outcome [5] 446754 0
Association of temperature change at atrioventricular node with ventriculo-atrial nodal effective refractory period
Timepoint [5] 446754 0
At time of procedure
Secondary outcome [6] 446756 0
Association of temperature change at atrioventricular node with junctional speeding
Timepoint [6] 446756 0
At time of procedure
Secondary outcome [7] 446752 0
Association of temperature change at atrioventricular node with onset of AH jump for Group 2
Timepoint [7] 446752 0
At time of procedure
Secondary outcome [8] 446749 0
Association of temperature change at atrioventricular node with HV interval
Timepoint [8] 446749 0
At time of procedure
Secondary outcome [9] 446757 0
Assess general quality of life and health pre and post-intervention
Timepoint [9] 446757 0
Baseline and 3 months post-procedure
Secondary outcome [10] 445998 0
Association of temperature change at atrioventricular node with atrioventricular nodal electrophysiology including onset of atrioventricular block for Group 1 only.
Timepoint [10] 445998 0
At time of procedure
Secondary outcome [11] 446753 0
Association of temperature change at atrioventricular node with atrioventricular nodal effective refractory period
Timepoint [11] 446753 0
At time of procedure
Secondary outcome [12] 446755 0
Association of temperature change at atrioventricular node with atrioventricular Wenckebach cycle length
Timepoint [12] 446755 0
At time of procedure

Eligibility
Key inclusion criteria
For Group 1: Adults referred for atrioventricular node ablation procedure
a. Permanent pacemaker in situ.

For Group 2: Adults referred for supraventricular tachycardia (SVT) ablation procedure (de novo or re-do)
a. Preference for patients with suspected atrioventricular nodal re-entrant tachycardia (AVNRT) based on 12-lead ECG of tachycardia during workup of SVT
b. Patient will be formally recruited to the study once diagnostic EP study documents peri-nodal SVT with preference for patients with AVNRT (patients will be consented for this prior to procedure)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy.
2. Age < 18
3. Unable to provide informed consent.
4. No inducible SVT: i.e. no ablation being performed (Group 2) or arrhythmia not peri-nodal

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed study is descriptive and no statistical infererence will be performed. Thus, no formal sample size or power calculations were performed. A standard group size for an observational interventional device trial has been chosen. Approximately 40 eligible participants, with 20 in each group.

Statistical analysis will be limited to descriptive and univariate analysis for all study endpoints. Descriptive findings will be reported as N(%) for categorical data and median (IQR) for continuous data, Correlation co-efficient will be calculated between temperature sensing data from the different temperature sensing electrodes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27443 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 43555 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 318086 0
Government body
Name [1] 318086 0
Melbourne Health
Country [1] 318086 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health - Innovation Acceleration Program
Address
Country
Australia
Secondary sponsor category [1] 320443 0
University
Name [1] 320443 0
University of Melbourne - Innovation Acceleration Program
Address [1] 320443 0
Country [1] 320443 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316734 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316734 0
Ethics committee country [1] 316734 0
Australia
Date submitted for ethics approval [1] 316734 0
22/04/2024
Approval date [1] 316734 0
03/12/2024
Ethics approval number [1] 316734 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138834 0
A/Prof Alex McLellan
Address 138834 0
Department of Cardiology, Royal Melbourne Hospital - City Campus Level 2, 300 Grattan Street, Parkville. VIC 3050
Country 138834 0
Australia
Phone 138834 0
+61 393427133
Fax 138834 0
Email 138834 0
[email protected]
Contact person for public queries
Name 138835 0
Danlu Liang
Address 138835 0
Department of Cardiology, Royal Melbourne Hospital - City Campus Level 2, 300 Grattan Street, Parkville. VIC 3050
Country 138835 0
Australia
Phone 138835 0
+61 393427133
Fax 138835 0
Email 138835 0
[email protected]
Contact person for scientific queries
Name 138836 0
Danlu Liang
Address 138836 0
Department of Cardiology, Royal Melbourne Hospital - City Campus Level 2, 300 Grattan Street, Parkville. VIC 3050
Country 138836 0
Australia
Phone 138836 0
+61 393427133
Fax 138836 0
Email 138836 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be made publicly available to maintain privacy and confidentiality.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.