Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

NCT03816033 | Unknown DMC

• 1 other identifier: IRAS236684
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Tachycardia; Wpw; Ventricular Tachycardia

Keywords

catheter ablation techniques

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• The rate of major adverse cerebrovascular and/or cardiovascular complications (defined as MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded

  24 months

• To record the patient quality of life improvement by filling in a Short Form-36 questionnaire

  24 months

Study Arms (2)

Cryotherapy

ACTIVE COMPARATOR

Cryotherapy ablation energy will be utilised in the catheter ablation procedure

Procedure: Cryotherapy

Radiofrequency

ACTIVE COMPARATOR

Radiofrequency ablation energy will be utilised in the catheter ablation procedure

Procedure: radiofrequency catheter ablation

Interventions

Cryotherapy PROCEDURE

Catheter ablation treatment for the treatment of the studied arrhythmias

Cryotherapy

radiofrequency catheter ablation PROCEDURE

Catheter ablation treatment for the treatment of the studied arrhythmias

Radiofrequency

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. George's Hospital, London: lead

Study Sites (1)

St.George's Hospital

London, SW170QT, United Kingdom

RECRUITING

Related Publications (9)

• 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.

  PMID: 25946280 BACKGROUND

• 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.

  PMID: 25281891 BACKGROUND

• 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.

  PMID: 26727045 BACKGROUND

• 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.

  PMID: 23475587 BACKGROUND

• 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.

  PMID: 16461833 BACKGROUND

• 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.

  PMID: 16680548 BACKGROUND

• 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.

  PMID: 22588748 BACKGROUND

• 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.

  PMID: 19467519 BACKGROUND

• 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.

  PMID: 22671922 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Wolff-Parkinson-White Syndrome; Tachycardia, Ventricular

Interventions

Cryotherapy; Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pre-Excitation Syndromes; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tachycardia

Intervention Hierarchy (Ancestors)

Therapeutics; Radiofrequency Ablation; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Anu Taiwo, Bsc

CONTACT

+4420287256606; mtaiwo@sgul.ac.uk

Lisa Leung, MBChB (Hons), MRCP (UK)

CONTACT

07952738053; lleung@sgul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physiologist analysing the Holter results and/or loop recorders for recurrence of arrhythmia will not know the randomised treatment for the study participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist and electrophysiologist

Model Details: This is a 1:1 randomised clinical controlled trial or a set of them, in our extensive program of research.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: January 25, 2019
• Study Start: June 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2023
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)