None listed
Conditions
Brief summary
Cardiac catheter ablation using radiofrequency (heating energy) is a common treatment for heart rhythm disorders. Catheters are long flexible tubes with electrodes at the tip placed in the heart and deliver heating or cooling thermal injury to disrupt abnormal electrical circuits in the heart (ablation). Radiofrequency ablation can be performed using catheters which are flushed continuously with water (irrigated) or with non-irrigated catheters which are dry. The benefits of irrigated catheters are that they can create larger and deeper injury to the abnormal circuits which may be more effective as the water prevents overheating. Importantly, irrigated catheters also have technology which determines if the catheter has adequate contact or pressure with the cardiac tissue it is ablating, known as contact force. This is vital in achieving a stable position to facilitate effective ablation. Failure to apply enough pressure or energy to the heart tissue consistently can result in poor quality ablation lesions and recurrence of the abnormal heart rhythm. Non-irrigated catheters do not have contact-force sensing capabilities. Catheter ablation is an effective treatment for a fast heart rhythm condition called atrioventricular nodal reentrant tachycardia (AVNRT). Traditionally, ablation has been performed with non-irrigated non-contact force-sensing catheters but more recently due to the benefits of irrigated and contact force-sensing catheters, more operators have been using them. Whilst initially there was concern larger lesions could potentially lead to higher risk of damaging the atrioventricular node, a vital electrical structure in the heart, multiple studies have shown irrigated contact force-sensing catheters are safe to use for this condition and may be even safer than non-irrigated non-contact force-sensing catheters. However, the benefits of contact force-sensing catheter ablation for AVNRT have not been evaluated in high-level evidence studies. A randomised control study is the gold-standard in comparing 2 treatments in research. We will be conducting a randomised trial comparing the effect contact force-sensing catheter ablation has during AVNRT ablation to non-contact force-sensing ablation. There will be 2 treatment groups of equal size with 51 in each for total of 102 patients. All patients will undergo AVNRT ablation using an irrigated contact force-sensing catheter. In half the group, the operator will not know the contact force and perform the procedure as per conventional standard practice. In the other half, the operator will know the contact force during ablation. This is to assess if contact force can make procedures faster, safer and more effective in treating AVNRT which will benefit future patients. Another goal is also to see if junctional rhythm (a finding suggestive of successful ablation) correlates with adequate pressure or contact force during ablation.
Interventions
Performing slow pathway ablations for atrioventricular nodal re-entrant tachycardia (AVNRT) diagnosed on electrophysiology study (EPS) using contact force-sensing ablation with QDOT MICRO™ catheter (Biosense and Webster, Inc, Irvine, CA) versus non-contact force-sensing ablation. Patients who are undergoing clinically-indicated supraventricular tachycardia ablation (SVT) ablation will be recruited from the procedural wait=list and clinics. A standard EPS will be performed with usual equipment. If EPS confirms they have AVNRT type of SVT and intended treatment is slow pathway ablation, they will be formally enrolled into study and randomised to one of 2 arms. A quality of life assessment using Short-Form 36 questionnaire will be conducted pre-procedure, 3 and 12 month post-procedure follow-up There are 2 arms. Both arms will utilise the QDOT MICRO™ ablation catheter for ablation of slow pathway, however Arm 1 (control arm) will have the operator blinded to the contact force of the QDOT MICRO™ ablation catheter whilst in Arm 2 (intervention arm), the operator is unblinded to contact force and able to utilise this information to assist the ablation. The same catheter is used in both arms to minimise variables introduced by different catheters at catheter-endocardial interface. Each arm will have 51 patients. Procedures will be performed by cardiac electrophysiologists under conscious sedation or general anaesthetic as per unit protocol or physician preference. Procedural length is approximately 1-2 hours. Primary and secondary outcome measures will be collected from procedural data and these will be analysed to monitor adherence to study protocol. Study investigators and operators will be briefed on the study protocol and monitoring data from WorkMate Claris™ and CARTO3 software will also be used to check study adherence. In Arm 2 (intervention), participants will undergo slow pathway ablation for typical AVNRT with the operator unblinded to the contact force. Participants will be followed-up at 3 months and 12 months as per routine clinical care with review of symptoms and ECG. Materials: baseline, 3-month and 12-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
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adults referred for SVT ablation procedure with suspected AVNRT based on 12-lead electrocardiograph of tachycardia during workup of SVT a. Patient will be formally recruited to the study once diagnostic EPS documents typical AVNRT (patients will be consented for this prior to procedure) 2. De novo ablation of the slow pathway performed
Exclusion criteria
1. Pregnancy. 2. Age < 18 3. Unable to provide informed consent. 4. Arrhythmia not consistent with typical AVNRT or slow pathway ablation will not be performed 5. Previous ablation attempt of the slow pathway 6. Having additional ablation at time of AVNRT e.g. pulmonary vein isolation