Trial Outcomes & Findings for Registry on WATCHMAN Outcomes in Real-Life Utilization (NCT NCT01972282)

NCT ID: NCT01972282

Last Updated: 2019-05-07

Results Overview

All device/procedure related Serious Adverse Events (with or without Major intervention)

• Recruitment status: COMPLETED
• Target enrollment: 1025 participants
• Primary outcome timeframe: 7 days post-implant
• Results posted on: 2019-05-07

Participant Flow

1025 patients scheduled for a WATCHMAN implant at 47 centers in 13 countries were enrolled over a time period of 19 months prior to the start of the procedure (Oct 2013 - May 2015)

5 patients signed the informed consent but never underwent the implant procedures. Those patients are classified as intents, they are included in epidemiological baseline analyses, but not on the endpoint analysis. 1020 patients underwent the implant procedure and are included in all endpoint analyses, regardless of the success of the implant.

Participant milestones

Measure	WATCHMAN Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
Overall Study STARTED	1020
Overall Study COMPLETED	1005
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	WATCHMAN n=1025 Participants Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
Age, Continuous	73.4 years STANDARD_DEVIATION 8.9 • n=1025 Participants
Sex: Female, Male Female	411 Participants n=1025 Participants
Sex: Female, Male Male	614 Participants n=1025 Participants
Region of Enrollment Russian Federation	81 Participants n=1025 Participants
Region of Enrollment United Kingdom	58 Participants n=1025 Participants
Region of Enrollment United Arab Emirates	8 Participants n=1025 Participants
Region of Enrollment Portugal	17 Participants n=1025 Participants
Region of Enrollment Spain	20 Participants n=1025 Participants
Region of Enrollment Saudi Arabia	15 Participants n=1025 Participants
Region of Enrollment Netherlands	79 Participants n=1025 Participants
Region of Enrollment Belgium	23 Participants n=1025 Participants
Region of Enrollment Ireland	37 Participants n=1025 Participants
Region of Enrollment Poland	38 Participants n=1025 Participants
Region of Enrollment Italy	56 Participants n=1025 Participants
Region of Enrollment France	61 Participants n=1025 Participants
Region of Enrollment Germany	532 Participants n=1025 Participants
CHADS-VASc	4.5 scores on a scale STANDARD_DEVIATION 1.6 • n=1025 Participants
HAS-BLED	2.3 scores on a scale STANDARD_DEVIATION 1.2 • n=1025 Participants

PRIMARY outcome

Timeframe: 7 days post-implant

All device/procedure related Serious Adverse Events (with or without Major intervention)

Outcome measures

Measure	WATCHMAN n=1020 Participants Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
Procedural Complications	2.8 percentage of participants

PRIMARY outcome

Timeframe: 2 year follow-up

Population: Patients who undergo WATCHMAN implant procedure in a commercial clinical setting

occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU

Outcome measures

Measure	WATCHMAN n=1020 Participants Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
Ischemic Stroke	1.26 Nr events/100 Patient-years Interval 0.79 to 1.9

PRIMARY outcome

Timeframe: 2 year follow-up

Population: Patients who undergo WATCHMAN implant in a commercial clinical setting.

All cause mortality

Outcome measures

Measure	WATCHMAN n=1020 Participants Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
Death	161 Participants

Adverse Events

WATCHMAN

Serious events: 26 serious events

Other events: 0 other events

Deaths: 161 deaths

Serious adverse events

Measure	WATCHMAN n=1020 participants at risk Patients who are implanted with the WATCHMAN device in a commercial clinical setting.
Cardiac disorders Procedural Device/Procedure related Serious Adverse Events	2.5% 26/1020 • Number of events 1020 • 2 years Overall number of participants who died due to any cause

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lucas V.A. Boersma

St. Antonius Ziekenhuis, Nieuwegein, Netherlands

Email: l.boersma@antoniusziekenhuis.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place