Cryotherapy Versus Radiofrequency Catheter Ablation Research Program

January 24, 2019 updated by: Dr. Mark M. Gallagher, St. George's Hospital, London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lisa Leung, MBChB (Hons), MRCP (UK)
  • Phone Number: 07952738053
  • Email: lleung@sgul.ac.uk

Study Locations

  • United Kingdom
      • London, United Kingdom, SW170QT
        • Recruiting
        • St.George's Hospital
        • Sub-Investigator:
          • Abhay Bajpai, MD
        • Sub-Investigator:
          • Zia Zuberi, PhD
        • Sub-Investigator:
          • Anthony Li, MD
        • Contact:
        • Principal Investigator:
          • Mark M Gallagher, MD
        • Principal Investigator:
          • Lisa WM Leung, MBChB
        • Sub-Investigator:
          • Manav Sohal, MD
        • Sub-Investigator:
          • Mark Norman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
12 months
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. George's Hospital, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS236684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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