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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
Catheter ablation treatment for the treatment of the studied arrhythmias
Catheter ablation treatment for the treatment of the studied arrhythmias
St.George's Hospital
London, United Kingdom
RECRUITINGRecurrence 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
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
Time frame: 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.
Time frame: 24 months
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