Atrial FibrillationNCT03816033
Cryotherapy Versus Radiofrequency Catheter Ablation Research Program
A study testing Cryotherapy and radiofrequency catheter ablation in people with Atrial Fibrillation and Atrial Tachycardia, run by St. George's Hospital, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Tachycardia, Wpw
- What is being tested?
- Cryotherapy and radiofrequency catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St.George's Hospital
London, SW170QT
Anu Taiwo, Bsc, 0208 725 6606 ext. 6606, mtaiwo@sgul.ac.uk
Mark M Gallagher, MD
About this study
Official title: Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Atrial Tachycardia, Wpw, Ventricular Tachycardia
- Being tested
- Cryotherapy, radiofrequency catheter ablation
- Keywords
- catheter ablation techniques
- Medical subject headings
- Atrial Fibrillation, Wolff-Parkinson-White Syndrome, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Catheter ablation treatment for the treatment of the studied arrhythmias
radiofrequency catheter ablationProcedure or surgery
Catheter ablation treatment for the treatment of the studied arrhythmias
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Active comparator | Cryotherapy ablation energy will be utilised in the catheter ablation procedure Receives: Procedure: Cryotherapy |
| Radiofrequency | Active comparator | Radiofrequency ablation energy will be utilised in the catheter ablation procedure Receives: Procedure: radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
A record of MACCE (MI, CVA, vascular, oesophageal trauma, phrenic nerve injury) will be recorded for all participants for 24 months
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Jun 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 1:1 randomised clinical controlled trial or a set of them, in our extensive program of research.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. George's Hospital, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mark M. Gallagher, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816033
- Sponsor's protocol ID
- IRAS236684
- Status last verified
- Jan 2019
- First submitted
- 6 Nov 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 25946280Ciconte 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.
PubMed 25281891Hunter 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.
PubMed 26727045Bisleri 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.
PubMed 23475587Haissaguerre 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.
PubMed 16461833Tada 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.
PubMed 16680548Hawker 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.
PubMed 22588748Aliot 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.
PubMed 19467519Andrade 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.
PubMed 22671922
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias
- ClinicalTrials.gov ID
- NCT03816033
- Acronym / sponsor ID
- IRAS236684
- Conditions
- Atrial Fibrillation, Atrial Tachycardia, Wpw, Ventricular Tachycardia
- Keywords
- catheter ablation techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- St. George's Hospital, LondonUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 1:1 randomised clinical controlled trial or a set of them, in our extensive program of research.
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Active comparator | Procedure: CryotherapyCryotherapy ablation energy will be utilised in the catheter ablation procedure |
| Radiofrequency | Active comparator | Procedure: radiofrequency catheter ablationRadiofrequency ablation energy will be utilised in the catheter ablation procedure |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyCatheter ablation treatment for the treatment of the studied arrhythmias | Procedure or surgery | Cryotherapy |
| radiofrequency catheter ablationCatheter ablation treatment for the treatment of the studied arrhythmias | Procedure or surgery | Radiofrequency |
Primary outcome
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.
2 secondary outcomes
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
To record the patient quality of life improvement by filling in a Short Form-36 questionnaire
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 25946280Verma 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.
- Background: PubMed 25281891Ciconte 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.
- Background: PubMed 26727045Hunter 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.
- Background: PubMed 23475587Bisleri 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.
- Background: PubMed 16461833Haissaguerre 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.
- Background: PubMed 16680548Tada 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.
- Background: PubMed 22588748Hawker 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.
- Background: PubMed 19467519Aliot 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.
- Background: PubMed 22671922Andrade 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and radiofrequency catheter ablation in people with Atrial Fibrillation and Atrial Tachycardia, run by St. George's Hospital, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anu Taiwo, Bsc (+4420287256606, mtaiwo@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of the treated arrhythmia at 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816033, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.