CONVERGE

  • STATUS
    Recruiting
  • sponsor
    AtriCure
Updated on 23 November 2020

Summary

CONVERGE

Description

This study is evaluating 2 different treatment options for persistent atrial fibrillation. In this multi-center, pivotal clinical study, patients are randomized (2:1) to either a convergent procedure that includes both epicardial and endocardial atrial ablation versus standalone endocardial catheter ablation. The study will enroll and randomize one hundred and fifty three (153) patients from up to thirty (30) sites with twenty-seven (27) in the US and three (3) sites OUS.

Study participants will need to come for procedure follow-up visits at 7 days, 1 month, 3 months, 6 months and 12 months after undergoing the study procedure.

Study participants will be continued to be followed long term with an office visit at 18months and phone follow-up after that at year 2, 3, 4, and 5 post procedure.

Details
Condition Atrial Fibrillation, Atrial Flutter, Fast Heart Rate (Tachycardia)
Clinical Study IdentifierTX145279
SponsorAtriCure
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

To be evaluated to participate in the study
you have to be between the age of 18 to 80
have persistent atrial fibrillation (AF)
your current atrial fibrillation medications are not working
you have not undergone a previous ablation for your AF
you do not have an implanted ICD
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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