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The RIPPLE AT-PLUS Study

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ClinicalTrials.gov Identifier: NCT03915691
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
Newcastle-upon-Tyne Hospitals NHS Trust
Guangdong General Hospital
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
Atrial tachycardia is a symptomatic arrhythmia, for which an effective treatment is a catheter ablation procedure. The goal of the Ripple AT plus study is to evaluate two methods of performing catheter ablation for atrial tachycardia. The main outcome assessed during the study is long-term recurrence of atrial tachycardia following the catheter ablation procedure.

Condition or disease Intervention/treatment Phase
Atrial Tachycardia Procedure: Catheter ablation of atrial tachycardia: Ripple Mapping guided. Procedure: Catheter ablation of atrial tachycardia: Conventional mapping guided. Not Applicable

Detailed Description:

Catheter based mapping of the electrical signals in the heart during atrial tachycardia can identify areas that require ablation in order to treat the arrhythmia. There are numerous methods by which to map atrial tachycardia. Ripple Mapping is one such method, and has recently been demonstrated to improve diagnostic accuracy of mapping and therefore improve acute procedural outcomes (termination of the tachycardia).

However, it is not known if improved acute procedural outcomes translate into long-term benefits for patients. At present, the recurrence rate following atrial tachycardia ablation is near 30%. We hypothesise that Ripple Mapping can reduce long-term recurrence following ablation as improved diagnostic accuracy of mapping can lead to more targeted, less extensive, ablation.

Patients referred for catheter ablation of atrial tachycardia will be randomised to undergo the procedure by Ripple Mapping or conventional mapping (local activation time). Otherwise, the catheters used to perform the mapping and ablation will be the same in both groups. After the procedure, follow up will occur at 3 monthly intervals for a year. All patients will undergo an ECG at each follow up, whilst patients with symptoms of atrial tachycardia will undergo a 24 hour ECG. Recurrence will be compared


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ripple Mapping Guided Ablation for Atrial Tachycardia: A Randomised Controlled Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Active Comparator: Ripple Mapping
Intervention: Ripple Mapping guided catheter ablation of atrial tachycardia.
Procedure: Catheter ablation of atrial tachycardia: Ripple Mapping guided.
Ripple Mapping (CARTO3v6 mapping system, Biosense Webster Inc) is used to map the atrial tachycardia mechanism. The Ripple Map is interpreted and catheter ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using Ripple Mapping. This can include lesions created at previous ablation procedures.

Active Comparator: Conventional Mapping
Intervention: conventional catheter ablation of atrial tachycardia.
Procedure: Catheter ablation of atrial tachycardia: Conventional mapping guided.
Conventional activation mapping (CARTO3v6 mapping system, Biosense Webster Inc) is used to map the atrial tachycardia mechanism. The resultant (activation) map is interpreted and ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using conventional mapping. This can include lesions created at previous ablation procedures.




Primary Outcome Measures :
  1. Atrial arrhythmia recurrence [ Time Frame: 12 months ]
    Any episode of sustained atrial arrhythmia (>30 seconds) occurring after catheter ablation and documented on the surface electrocardiogram.


Secondary Outcome Measures :
  1. Acute success during the catheter ablation procedure by the first ablation set. [ Time Frame: Procedure. ]
    Atrial tachycardia termination (acute success) during ablation delivered to only target the diagnosed AT mechanism by the mapping approach used (first ablation set).

  2. Acute success during the catheter ablation procedure without the need of entrainment. [ Time Frame: Procedure. ]
    Entrainment not required to confirm or exclude the diagnosis made by 3D electroanatomic mapping methods.

  3. Procedure failure. [ Time Frame: Procedure. ]
    Inability to terminate atrial tachycardia during the catheter ablation procedure, requiring external electrical cardioversion to achieve sinus rhythm.

  4. Total procedure time. [ Time Frame: Procedure. ]
    Procedure time measured from initiation of intracardiac mapping to catheter removal from the body.

  5. Requirement for repeat catheter ablation of atrial tachycardia procedure. [ Time Frame: 12 months. ]
    Any patient meeting the primary outcome who is also referred for a repeat catheter ablation procedure.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Referred for catheter ablation of AT by the direct care team, based on clinical indication.
  2. Sustained AT (>30 seconds) documented on the surface electrocardiogram.
  3. Male or female, aged 18 - 80 years old.
  4. Able to consent for recruitment to the trial and the catheter ablation procedure.
  5. Suitable candidate for a catheter ablation procedure.

Exclusion Criteria:

  1. Contraindication to catheter ablation.
  2. Typical atrial flutter on ECG.
  3. AT due to reversible causes.
  4. Severe valvular disease or ventricular thrombus.
  5. Active gastrointestinal bleeding.
  6. Life expectancy shorter than the duration of the trial.
  7. Allergy to contrast.
  8. Intractable heart failure (NYHA Class IV).
  9. Bleeding or clotting disorders or inability to receive heparin.
  10. Malignancy needing surgery, chemotherapy or radiotherapy.
  11. Pregnancy or women of child-bearing potential not using a highly effective method of contraception.

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): NCT03915691


Contacts
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Contact: George Katritsis, MBChB +447769201451 g.katritsis@ic.ac.uk
Contact: Prapa Kanagaratnam, MBBChir +447769201451 p.kanagaratnam@ic.ac.uk

Locations
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China, Guangdong
Guangdong General Hospital Not yet recruiting
Guangzhou, Guangdong, China
Contact: Yang Liu, MD         
United Kingdom
Hammersmith Hospital Not yet recruiting
London, United Kingdom, W12 0HS
Contact: George Katritsis, MBChB       g.katritsis@ic.ac.uk   
Principal Investigator: Prapa Kanagaratnam, MBBChir         
Sub-Investigator: Nick Linton, MBBS         
Sub-Investigator: Vishal Luther, MBBS         
Freeman Hospital, The Newcastle Upon Tyne NHS Foundation Trust Not yet recruiting
Newcastle, United Kingdom, NE7 7DN
Contact: Ruairidh Martin       ruairidh.martin@nuth.nhs.uk   
Sponsors and Collaborators
Imperial College London
Newcastle-upon-Tyne Hospitals NHS Trust
Guangdong General Hospital
Investigators
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Principal Investigator: Prapa Kanagaratnam, MBBChir Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03915691     History of Changes
Other Study ID Numbers: 19SM5013
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Imperial College London:
Atrial Tachycardia
Atrial Fibrillation
Mapping
Ablation
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes