Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

Study Overview
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Brief Summary
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A program of research has been set up at St. George's Hospital, London studyng the practicalities of catheter ablation. The current practice of catheter ablation is being studied for a range of arrhythmias including PAF, persistent AF, advanced persistent AF and resistant WPW.

Detailed Description
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The study design will be a separate randomised clinical trial for each of the arrhythmias studied. There will be 1:1 randomisation to either the cryotherapy protocol or RF protocol. Arrhythmia patients already under the care of this cardiac centre, who have already opted for catheter ablation treatment will be approached to ask if they will also be willing to participate in this longterm research program. The protocols for each different arrhythmia are in line with current practice and knowledge and utilising current technology. In the program, the investigators have 1 or 2 protocols that mildly differ from conventional use but have already passed through initial experience with publication on this- this is the multi-catheter cryocatheter approach. Acute procedural outcomes, short, medium and longterm success will be recorded for each patient, in addition to patient or participant experience and quality of life outcomes. The catheter ablation research program has passed through ethical panel review in London and has the potential to become a multi-centre study.

Official Title
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Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias

Conditions
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Atrial Fibrillation, Atrial Tachycardia, Wpw, Ventricular Tachycardia

Intervention / Treatment
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* Procedure: Cryotherapy
* Procedure: radiofrequency catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients under the care of the Arrhythmia Service at St. George's Hospital with one of the studied arrhythmia (PAF, persistent AF etc), awaiting catheter ablation treatment will be eligible for inclusion to the program of research Exclusion Criteria: Vulnerable patients will be excluded- e.g. active cancer, inability to consent Paediatric patients will not be studied Patients awaiting standard SVT catheter ablation treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 1:1 randomised clinical controlled trial or a set of them, in our extensive program of research.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryotherapy<br>Cryotherapy ablation energy will be utilised in the catheter ablation procedure | Procedure: Cryotherapy<br>* Catheter ablation treatment for the treatment of the studied arrhythmias<br>|
| Active Comparator: Radiofrequency<br>Radiofrequency ablation energy will be utilised in the catheter ablation procedure | Procedure: radiofrequency catheter ablation<br>* Catheter ablation treatment for the treatment of the studied arrhythmias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of the treated arrhythmia at 6 months | Recurrence of the treated arrhythmia or related tachycardia will be recorded in a single timeframe of 6 months. The method for recording recurrence will be from Holter or via loop recorder download. | 6 months | 
| Recurrence of the treated arrhythmia at 12 months | Recurrence of the treated arrhythmia or related tachycardia will be recorded in a single timeframe of 12 months. The method for recording recurrence will be from Holter or via loop recorder download. | 12 months | 
| Recurrence of the treated arrhythmia at 24 months | Recurrence of the treated arrhythmia or related tachycardia will be recorded in a single timeframe of 24 months. The method for recording recurrence will be from Holter or via loop recorder download. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of major adverse cerebrovascular and/or cardiovascular complications (defined as MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded | A record of MACCE (MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded for all participants for 24 months | 24 months | 
| To record the patient quality of life improvement by filling in a Short Form-36 questionnaire | The validated questionnaire is called the General Health Short Form-36 questionnaire. It is a general health questionnaire with 36 questions. The scoring system works from 0-100. The higher the score, the more favourable the general well-being of the patient or participant. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation techniques