Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

St. George's Hospital, London

Status: Unknown

Conditions: Atrial Tachycardia; Atrial Fibrillation; Wpw; Ventricular Tachycardia

Treatments: Procedure: radiofrequency catheter ablation; Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03816033

IRAS236684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Cryotherapy

Active Comparator group

Description:

Cryotherapy ablation energy will be utilised in the catheter ablation procedure

Treatment:

Procedure: Cryotherapy

Radiofrequency

Active Comparator group

Description:

Radiofrequency ablation energy will be utilised in the catheter ablation procedure

Treatment:

Procedure: radiofrequency catheter ablation