Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

Overview

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 Title of Study: “Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2021

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.

Interventions

  • Procedure: Cryotherapy
    • Catheter ablation treatment for the treatment of the studied arrhythmias
  • Procedure: radiofrequency catheter ablation
    • Catheter ablation treatment for the treatment of the studied arrhythmias

Arms, Groups and Cohorts

  • Active Comparator: Cryotherapy
    • Cryotherapy ablation energy will be utilised in the catheter ablation procedure
  • Active Comparator: Radiofrequency
    • Radiofrequency ablation energy will be utilised in the catheter ablation procedure

Clinical Trial Outcome Measures

Primary Measures

  • Recurrence of the treated arrhythmia at 6 months
    • Time Frame: 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 12 months
    • Time Frame: 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 24 months
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 88 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. George’s Hospital, London
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Mark M. Gallagher, Consultant Cardiologist and electrophysiologist – St. George’s Hospital, London
  • Overall Contact(s)
    • Anu Taiwo, Bsc, +4420287256606, mtaiwo@sgul.ac.uk

References

Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

Ciconte G, Ottaviano L, de Asmundis C, Baltogiannis G, Conte G, Sieira J, Di Giovanni G, Saitoh Y, Irfan G, Mugnai G, Storti C, Montenero AS, Chierchia GB, Brugada P. Pulmonary vein isolation as index procedure for persistent atrial fibrillation: One-year clinical outcome after ablation using the second-generation cryoballoon. Heart Rhythm. 2015 Jan;12(1):60-6. doi: 10.1016/j.hrthm.2014.09.063. Epub 2014 Oct 2.

Hunter RJ, Baker V, Finlay MC, Duncan ER, Lovell MJ, Tayebjee MH, Ullah W, Siddiqui MS, McLEAN A, Richmond L, Kirkby C, Ginks MR, Dhinoja M, Sporton S, Earley MJ, Schilling RJ. Point-by-Point Radiofrequency Ablation Versus the Cryoballoon or a Novel Combined Approach: A Randomized Trial Comparing 3 Methods of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation (The Cryo Versus RF Trial). J Cardiovasc Electrophysiol. 2015 Dec;26(12):1307-14. doi: 10.1111/jce.12846. Epub 2015 Nov 25.

Bisleri G, Rosati F, Bontempi L, Curnis A, Muneretto C. Hybrid approach for the treatment of long-standing persistent atrial fibrillation: electrophysiological findings and clinical results. Eur J Cardiothorac Surg. 2013 Nov;44(5):919-23. doi: 10.1093/ejcts/ezt115. Epub 2013 Mar 8.

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.

Tada H, Yamada M, Naito S, Nogami A, Oshima S, Taniguchi K. Radiofrequency catheter ablation within the coronary sinus eliminates a macro-reentrant atrial tachycardia: importance of mapping in the coronary sinus. J Interv Card Electrophysiol. 2006 Jan;15(1):35-41. doi: 10.1007/s10840-006-6310-2.

Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Della Bella P, Hindricks G, Jais P, Josephson ME, Kautzner J, Kay GN, Kuck KH, Lerman BB, Marchlinski F, Reddy V, Schalij MJ, Schilling R, Soejima K, Wilber D; European Heart Rhythm Association (EHRA); Registered Branch of the European Society of Cardiology (ESC); Heart Rhythm Society (HRS); American College of Cardiology (ACC); American Heart Association (AHA). EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European Heart Rhythm Association (EHRA), a Registered Branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm. 2009 Jun;6(6):886-933. doi: 10.1016/j.hrthm.2009.04.030. No abstract available.

Andrade JG, Dubuc M, Guerra PG, Macle L, Mondesert B, Rivard L, Roy D, Talajic M, Thibault B, Khairy P. The biophysics and biomechanics of cryoballoon ablation. Pacing Clin Electrophysiol. 2012 Sep;35(9):1162-8. doi: 10.1111/j.1540-8159.2012.03436.x. Epub 2012 Jun 5.

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