Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

Not Applicable

• Conditions: Atrial Fibrillation; Wpw; Atrial Tachycardia; Ventricular Tachycardia
• Interventions: Procedure: Cryotherapy; Procedure: radiofrequency catheter ablation

• Registration Number: NCT03816033
• Lead Sponsor: St. George's Hospital, London

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-11-06
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-24
• Last Update Submitted: 2019-01-24
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-25
• Primary Completion: 2021-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	Cryotherapy ablation energy will be utilised in the catheter ablation procedure
Radiofrequency	radiofrequency catheter ablation	Radiofrequency ablation energy will be utilised in the catheter ablation procedure

Primary Outcome Measures

Name	Time	Method
Recurrence of the treated arrhythmia at 12 months	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.
Recurrence of the treated arrhythmia at 6 months	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.
Recurrence of the treated arrhythmia at 24 months	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.

Secondary Outcome Measures

Name	Time	Method
To record the patient quality of life improvement by filling in a Short Form-36 questionnaire	24 months	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.
The rate of major adverse cerebrovascular and/or cardiovascular complications (defined as MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded	24 months	A record of MACCE (MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded for all participants for 24 months

Trial Locations

Locations (1)

St.George's Hospital; 🇬🇧 London, United Kingdom