WATCHMAN Left Atrial Appendage System for Embolic PROTECT... | NCT00129545

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WATCHMAN	Experimental	Implant of WATCHMAN Left Atrial Appendage Closure Technology	Device: WATCHMAN Left Atrial Appendage Closure Technology
Warfarin control	Active Comparator	Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin	Drug: Warfarin
Roll-in	Other	Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.	Device: WATCHMAN Left Atrial Appendage Closure Technology

Name	Type	Description	Arm Group Labels	Other Names
WATCHMAN Left Atrial Appendage Closure Technology	Device	Implant of WATCHMAN Left Atrial Appendage Closure Technology	Roll-in WATCHMAN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death	A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)	5 years
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events	Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.	5 years

Measure	Description	Time Frame
Procedure Success	Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.	Initial implant procedure

Eligibility Module

Name	Affiliation	Role
David Holmes, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Cardiac Specialists		Gilbert	Arizona	85233	United States
Arizona Arrhythmia

PubMed Identifier	Type	Citation	Retractions
35902169	Derived	Dukkipati SR, Holmes DR Jr, Doshi SK, Kar S, Singh SM, Gibson D, Price MJ, Natale A, Mansour M, Sievert H, Houle VM, Allocco DJ, Reddy VY. Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure. J Am Coll Cardiol. 2022 Aug 2;80(5):469-483. doi: 10.1016/j.jacc.2022.04.062.
31752643	Derived

Label	URL
Sponsor website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Roll-in	Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
FG001	WATCHMAN	Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death

A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)

event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics

Roll-in subjects were not included in the primary outcome analysis per study design.

Posted

Number

95% Confidence Interval

events per 100 pt yrs

5 years

ID	Title	Description
OG000	Implantable Device	Implantable WATCHMAN Left ATrial Appendage Occlusion Device WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology
OG001	Warfarin Control	Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin Warfarin: Subjects receive warfarin

Units	Counts
Participants	OG000463 OG001244

Title

Denominators

Categories

Title	Measurements
	OG0002.2(1.7 to 3.1) OG0013.7(2.4 to 4.8)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Ratio (RR)	0.61			2-Sided	95	0.42	1.07			Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals	Yes	Non-Inferiority or Equivalence	The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.

Primary

The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events

Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.

Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics

Roll-in subjects were not included in the primary outcome analysis per study design.

Posted

Number

95% Confidence Interval

Events per 100 pt-yrs

5 years

ID	Title	Description
OG000	Implantable Device	Implantable WATCHMAN Left ATrial Appendage Occlusion Device WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology
OG001	Warfarin Control	Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin Warfarin: Subjects receive warfarin

Units	Counts
Participants

Secondary

Procedure Success

Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

14 subjects did not have an implant procedure attempted

Posted

Number

percentage of implant attempts

Initial implant procedure

ID	Title	Description
OG000	WATCHMAN	Implantable WATCHMAN Left ATrial Appendage Occlusion Device Implant of WATCHMAN Left Atrial Appendage Closure Technology

Units	Counts
Participants	OG000449

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia Requiring Transfusion	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected463 at risk EG0024 events1 affected244 at risk
Arrhythmias	Cardiac disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected463 at risk EG0020 events0 affected244 at risk
AV Fistula	Vascular disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Bleeding from Varicose Veins	Vascular disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Bruising - Hematoma	Vascular disorders	Systematic Assessment	EG0002 events2 affected93 at risk EG0015 events5 affected463 at risk EG0020 events0 affected244 at risk
Cardiac Perforation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0017 events7 affected463 at risk EG0020 events0 affected244 at risk
Cranial Bleed	Vascular disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0014 events4 affected463 at risk EG0021 events1 affected244 at risk
Death	General disorders	Systematic Assessment	EG0005 events5 affected93 at risk EG00159 events59 affected463 at risk EG00244 events44 affected244 at risk
Device Embolization	Investigations	Systematic Assessment	EG0000 events0 affected93 at risk EG0014 events3 affected463 at risk EG0020 events0 affected244 at risk
Device Thrombus	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected463 at risk EG0020 events0 affected244 at risk
Epistaxis	Vascular disorders	Systematic Assessment	EG0002 events2 affected93 at risk EG0014 events4 affected463 at risk EG0020 events0 affected244 at risk
Gastrointestinal Bleeding	Gastrointestinal disorders	Systematic Assessment	EG00012 events9 affected93 at risk EG00132 events26 affected463 at risk EG00227 events22 affected244 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0014 events4 affected463 at risk EG0020 events0 affected244 at risk
Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected93 at risk EG0012 events2 affected463 at risk EG0020 events0 affected244 at risk
Major Bleed Requiring Transfusion	Vascular disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0012 events2 affected463 at risk EG0021 events1 affected244 at risk
Oral Bleeding	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected463 at risk EG0021 events1 affected244 at risk
Other Study Related	Investigations	Systematic Assessment	EG0004 events4 affected93 at risk EG00118 events17 affected463 at risk EG0022 events2 affected244 at risk
Pericardial Effusion with Cardiac Tamponade	Cardiac disorders	Systematic Assessment	EG0004 events4 affected93 at risk EG00113 events13 affected463 at risk EG0020 events0 affected244 at risk
Pericardial Effusion-Serious	Cardiac disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0014 events4 affected463 at risk EG0020 events0 affected244 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Pseudoaneurysm	Vascular disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0013 events3 affected463 at risk EG0020 events0 affected244 at risk
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Rectal Bleeding	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0011 events1 affected463 at risk EG0021 events1 affected244 at risk
Stroke - Hemorrhagic	Nervous system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0013 events3 affected463 at risk EG00210 events10 affected244 at risk
Stroke - Ischemic	Nervous system disorders	Systematic Assessment	EG0005 events5 affected93 at risk EG00126 events24 affected463 at risk EG00211 events10 affected244 at risk
Systemic Embolization	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0013 events3 affected463 at risk EG0020 events0 affected244 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Transient Ischemic Attack (TIA)	Nervous system disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0015 events5 affected463 at risk EG0020 events0 affected244 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Air Embolism	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Allergic Reaction to Contrast Media	Immune system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Anemia Requiring Transfusion	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected463 at risk EG0021 events1 affected244 at risk
AV Fistula	Vascular disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Bleeding from Varicose Veins	Vascular disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Bruising - Hematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0013 events3 affected463 at risk EG0022 events2 affected244 at risk
Device Thrombus	Investigations	Systematic Assessment	EG0002 events2 affected93 at risk EG00115 events14 affected463 at risk EG0020 events0 affected244 at risk
Epistaxis	Vascular disorders	Systematic Assessment	EG0004 events4 affected93 at risk EG00113 events11 affected463 at risk EG0025 events5 affected244 at risk
Gastrointestinal Bleeding	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0013 events3 affected463 at risk EG0022 events2 affected244 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected463 at risk EG0022 events2 affected244 at risk
Inability to Move or Retrieve Device	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Oral Bleeding	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected463 at risk EG0021 events1 affected244 at risk
Other Non-Study Related	General disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected463 at risk EG0020 events0 affected244 at risk
Other Study Related	Investigations	Systematic Assessment	EG0009 events9 affected93 at risk EG00120 events19 affected463 at risk EG0022 events2 affected244 at risk
Pericardial Effusion	Cardiac disorders	Systematic Assessment	EG0003 events3 affected93 at risk EG00110 events10 affected463 at risk EG0020 events0 affected244 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Rectal Bleeding	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0015 events3 affected463 at risk EG0025 events5 affected244 at risk
Stroke - Ischemic	Nervous system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk
Transient Ischemic Attack (TIA)	Nervous system disorders	Systematic Assessment	EG0001 events1 affected93 at risk EG0012 events2 affected463 at risk EG0020 events0 affected244 at risk
Vasovagal Reactions	Nervous system disorders	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected463 at risk EG0020 events0 affected244 at risk

ID	Term
D001281	Atrial Fibrillation
D020521	Stroke
D002546	Ischemic Attack, Transient

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002545	Brain Ischemia

ID	Term
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	WATCHMAN	WATCHMAN Left Atrial Appendage Closure Technology:
BG001	Warfarin Control	Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
BG002	Roll-in	Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Roll-in	Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase	29	93	19	93
EG001	WATCHMAN	Randomized to receive implantation of the WATCHMAN LAA closure Device	143	463	71	463
EG002	WARFARIN	Randomized to receive Warfarin control	70	244	17	244