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Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

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ClinicalTrials.gov Identifier: NCT03816033
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Mark M. Gallagher, St. George's Hospital, London

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Tachycardia Wpw Ventricular Tachycardia Procedure: Cryotherapy Procedure: radiofrequency catheter ablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 1:1 randomised clinical controlled trial or a set of them, in our extensive program of research.
Masking: Single (Outcomes Assessor)
Masking Description: The physiologist analysing the Holter results and/or loop recorders for recurrence of arrhythmia will not know the randomised treatment for the study participant.
Primary Purpose: Treatment
Official Title: Multi-catheter Cryotherapy Versus Radiofrequency Catheter Ablation for the Treatment of Standard and Resistant Arrhythmias
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Active Comparator: Cryotherapy
Cryotherapy ablation energy will be utilised in the catheter ablation procedure
Procedure: Cryotherapy
Catheter ablation treatment for the treatment of the studied arrhythmias

Active Comparator: Radiofrequency
Radiofrequency ablation energy will be utilised in the catheter ablation procedure
Procedure: radiofrequency catheter ablation
Catheter ablation treatment for the treatment of the studied arrhythmias




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816033


Contacts
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Contact: Anu Taiwo, Bsc +4420287256606 mtaiwo@sgul.ac.uk
Contact: Lisa Leung, MBChB (Hons), MRCP (UK) 07952738053 lleung@sgul.ac.uk

Locations
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United Kingdom
St.George's Hospital Recruiting
London, United Kingdom, SW170QT
Contact: Anu Taiwo, Bsc    0208 725 6606 ext 6606    mtaiwo@sgul.ac.uk   
Principal Investigator: Mark M Gallagher, MD         
Principal Investigator: Lisa WM Leung, MBChB         
Sub-Investigator: Manav Sohal, MD         
Sub-Investigator: Zia Zuberi, PHD         
Sub-Investigator: Abhay Bajpai, MD         
Sub-Investigator: Anthony Li, MD         
Sub-Investigator: Mark Norman, MD         
Sponsors and Collaborators
St. George's Hospital, London

Publications:
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.

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Responsible Party: Dr. Mark M. Gallagher, Consultant Cardiologist and electrophysiologist, St. George's Hospital, London
ClinicalTrials.gov Identifier: NCT03816033     History of Changes
Other Study ID Numbers: IRAS236684
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Mark M. Gallagher, St. George's Hospital, London:
catheter ablation techniques
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease