An interventional study of Cryotherapy and radiofrequency catheter ablation in Atrial Fibrillation, Atrial Tachycardia and Wpw, sponsored by St. George's Hospital, London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2019-01-25.
Sponsored by St. George's Hospital, London · Not applicable, Interventional, and Treatment
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 600 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →St. George's Hospital, London is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cryotherapy ablation energy will be utilised in the catheter ablation procedure
Procedure: Cryotherapy
Radiofrequency ablation energy will be utilised in the catheter ablation procedure
Procedure: radiofrequency catheter ablation
Catheter ablation treatment for the treatment of the studied arrhythmias
Catheter ablation treatment for the treatment of the studied arrhythmias
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.
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
Plan to share: No — The research data will be kep in a closed system within our NHS centre to the direct care team and researchers. Once anonymised data is available to be presented, it will be presented on an international stage and publications are expected, in respected journals.
Started Jun 2018 (actual). Primary completion is estimated for Jun 2021, 36 months after the start.
Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 36 months is close to that.
Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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St. George's Hospital, London