Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03173534
Eligibility Criteria:
Inclusion Criteria:
1. Men and women ≥ 18 years of age.
2. The patient meets criteria for and is scheduled to undergo TAVR procedure
3. The patient has documented paroxysmal, persistent, or permanent atrial fibrillation.
4. The patient meets the WATCHMAN labeling guidelines and is eligible to undergo the WATCHMAN implantation procedure.
5. The patient is eligible for short term warfarin therapy.
6. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
7. The patient is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
1. The patient had a stroke or TIA within the last 6 months prior to enrollment.
2. Contraindication for short term anticoagulation.
3 .Moderate or severe Mitral Stenosis with mean gradient across Mitral Valve \>10 mm Hg or Mitral Valve Area \< 1.2cm2.
4\. The patient has symptomatic carotid disease (i.e.,carotid stenosis ≥ 50% associated with ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months).
5\. Prior occlusion of LAA.
6\. The patient has an implanted mechanical mitral valve.
7\. The patient requires long-term warfarin therapy due to:
1. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months
2. The patient is in a hypercoaguable state; exclude the patient if per medical record documentation, the patient meets any of the following criteria:
* Thrombosis occurring ≤ 40 years of age
* Idiopathic or recurrent VTE (venous thrombo-embolism)
* Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins)
* Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anticoagulated.
8\. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).
9\. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.
10\. Any clinically significant medical condition or presence of any laboratory abnormality prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or WATCHMAN.
11\. The patient has a life expectancy of less than two years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03173534
Study Brief:
Protocol Section:
NCT03173534