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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613831
Recruitment Status : Withdrawn (The sponsor has decided to stop the study)
First Posted : August 3, 2018
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment
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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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. target patient's type [ Time Frame: 1 year ]
    Type of atrial tachycardia post atrial fibrillation ablation or cardiac surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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

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): NCT03613831


Locations
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China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Boston Scientific Corporation
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03613831    
Other Study ID Numbers: PCR02
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease