Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
Conditions
Brief summary
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.
Interventions
DEVICEpatient who used Rhythmia system and Orion catheter
suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject with atrial tachycardia (including atrial flutter) post atrial fibrillation ablation or cardiac surgery, which occurred at least 90 days prior to enrollment; 2. Subject is suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion 3. Subject is age 18 or above; 4. Subject or his/ her legal representive understands and is willing to provide the Informed Consent Form (ICF) and participate in this trail.
Exclusion criteria
1. Subject with atrial fibrillation only; 2. Subject is enrolled in any other concurrent study that might interfere with this study; 3. Women of childbearing potential who are or might be pregnant at the time of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| target patient's type | 1 year | Type of atrial tachycardia post atrial fibrillation ablation or cardiac surgery. |
Countries
China
Outcome results
None listed