Clinical trial NCT03816033: Cryotherapy Versus Radiofrequency Catheter Ablation Research Program
Official title: Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Atrial Tachycardia
Wpw
Ventricular Tachycardia
Keywords: catheter ablation techniques
Lead sponsor: St. George's Hospital, London
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 1:1 randomised clinical controlled trial or a set of them, in our extensive program of research.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of the treated arrhythmia at 6 months
timeFrame: 6 months
measure: Recurrence of the treated arrhythmia at 12 months
timeFrame: 12 months
measure: Recurrence of the treated arrhythmia at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: The rate of major adverse cerebrovascular and/or cardiovascular complications (defined as MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded
timeFrame: 24 months
measure: To record the patient quality of life improvement by filling in a Short Form-36 questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St.George's Hospital
Study officials:
References:
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citation: Haissaguerre M, Hocini M, Sanders P, Takahashi Y, Rotter M, Sacher F, Rostock T, Hsu LF, Jonsson A, O'Neill MD, Bordachar P, Reuter S, Roudaut R, Clementy J, Jais P. Localized sources maintaining atrial fibrillation organized by prior ablation. Circulation. 2006 Feb 7;113(5):616-25. doi: 10.1161/CIRCULATIONAHA.105.546648.
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