The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.

Description

Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria.

Conditions

Paroxysmal Atrial Fibrillation

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Study Overview

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Study Details

Study overview

Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria.

The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO™ System Use in Conjunction With VISITAG SURPOINT™Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.

Condition
Paroxysmal Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Lynchburg

Centra Health, Inc.dba Stroobants Cardiovascular Center, Lynchburg, Virginia, United States, 24501

Janesville

Mercy Health, Janesville, Wisconsin, United States, 53548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
  • 2. 18 years of age or older
  • 3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
  • 4. Willing and able to provide informed consent for this sub-study
  • 1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
  • 2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
  • 3. Persistent or long-standing persistent AF
  • 4. In the opinion of the investigator, any known contraindication to an ablation procedure

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Heart Rhythm Clinical and Research Solutions, LLC,

Study Record Dates

2028-03