The RIPPLE AT-PLUS Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03915691|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : August 3, 2020
|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|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ripple Mapping Guided Ablation for Atrial Tachycardia: A Randomised Controlled Trial|
|Actual Study Start Date :||June 23, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2022|
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.
- 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.
- 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).
- 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.
- Procedure failure. [ Time Frame: Procedure. ]Inability to terminate atrial tachycardia during the catheter ablation procedure, requiring external electrical cardioversion to achieve sinus rhythm.
- Total procedure time. [ Time Frame: Procedure. ]Procedure time measured from initiation of intracardiac mapping to catheter removal from the body.
- 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.
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
|Contact: George Katritsis, MBChBemail@example.com|
|Contact: Prapa Kanagaratnam, MBBChirfirstname.lastname@example.org|
|London, United Kingdom, W12 0HS|
|Contact: George Katritsis, MBChB email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Prapa Kanagaratnam, MBBChir||Imperial College London|