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ClinicalTrials.gov Identifier: NCT03613831
Recruitment Status :
(The sponsor has decided to stop the study)
This study is an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or cardiac surgery guided with Rhythmia System.
Condition or disease
Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
Device: patient who used Rhythmia system and Orion catheter
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
An arbitrary sample size of 100 should be enough for this registry study which may cover the focal, macro-reentry, micro-reentry and other types of atrial tachycardia. Assuming that the one-year recurrence rate post complex atrial tachycardia ablation is 30%, the 95% confidence interval of 100 samples shall be 21.2-40.0% (binomial distribution exact method).
As per the current actual situation in China, it is predicted that 70-80 cases may be included for the atrial tachycardia post atrial fibrillation ablation, while 20-30 cases may be included for post cardiac surgery.
Subject with atrial tachycardia (including atrial flutter) post atrial fibrillation ablation or cardiac surgery, which occurred at least 90 days prior to enrollment;
Subject is suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
Subject is age 18 or above;
Subject or his/ her legal representive understands and is willing to provide the Informed Consent Form (ICF) and participate in this trail.
Subject with atrial fibrillation only;
Subject is enrolled in any other concurrent study that might interfere with this study;
Women of childbearing potential who are or might be pregnant at the time of this study