HEAL-LAA Clinical Trial (HEAL-LAA)

Overview

About this study

The purpose of this study is to collect real-world outcomes data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients who are implanted with the WATCHMAN FLX Pro device in a commercial clinical setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Subject is of legal age to participate in the study.

- Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).

- Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device.

- Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.

- Subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

- Subject has a documented life expectancy of less than 6 months.

- Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.

- Intracardiac thrombus is present.

- An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.

- The LAA anatomy will not accommodate a Closure Device.

- The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMANFLX™ Pro Device is contraindicated.

- Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal 
echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.

- There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.

- Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ammar Killu, M.B.B.S.

Open for enrollment

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available