Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

Atrial Fibrillation Clinical Trial

Official title:

Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03816033
• Other study ID #: IRAS236684
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 2023

Study information

• Verified date: January 2019
• Source: St. George's Hospital, London
• Contact: Anu Taiwo, Bsc
• Phone: +4420287256606
• Email: mtaiwo[@]sgul.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2023
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Tachycardia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia
• Wpw

Intervention

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

Locations

Country	Name	City	State
United Kingdom	St.George's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
St. George's Hospital, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Della Bella P, Hindricks G, Jaïs 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. — View Citation

Andrade JG, Dubuc M, Guerra PG, Macle L, Mondésert 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. Review. — View Citation

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. — View Citation

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. — View Citation

Haïssaguerre 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, Clémenty J, Jaïs P. Localized sources maintaining atrial fibrillation organized by prior ablation. Circulation. 2006 Feb 7;113(5):616-25. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	24 months
Secondary	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	24 months
Secondary	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.	24 months