Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)

Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery Clinical Trial

Official title:

Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03613831
• Other study ID #: PCR02
• Status: Withdrawn
• Start date: December 2020
• Est. completion date: February 2023

Study information

• Verified date: August 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
• Tachycardia

Intervention

Device:
• patient 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

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target patient's type	Type of atrial tachycardia post atrial fibrillation ablation or cardiac surgery.	1 year