NCT02471131

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality. The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular AF. The WATCHMAN™ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with epicardial devices is known to be difficult and not free of risks.It thus will be interesting to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid ablation approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

May 20, 2015

Last Update Submit

January 10, 2017

Conditions

Atrial FibrillationStroke

Keywords

WATCHMANAtrial FibrillationHybrid AblationSafetyFeasibilityStroke Prevention

Outcome Measures

Primary Outcomes (2)

  • Major complications during follow-up, assessed by scoring the number of complications

    6 months

  • Device success, assessed by transesophageal echocardiogram.

    6 months

Study Arms (1)

WATCHMAN Implantation

EXPERIMENTAL
Device: WATCHMAN Device implantation

Interventions

WATCHMAN Device implantationDEVICE

The implantation of the device will be done into the left atrial appendage according to the guidelines.

WATCHMAN Implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation,
  • Eligible at least for short-term OAC therapy,
  • No other conditions that would require long-term OAC therapy, suggested by current standard medical practice, and thus is eligible to stop OAC if the LAA is sealed,
  • Calculated CHA2DS2-VASc score of 1 or more,
  • years of age or older, able and willing to provide written informed consent.

You may not qualify if:

  • Current New York Heart Association Class IV Congestive Heart Failure,
  • Current thrombocytopenia (\< 100x10E9/L) or anemia (hemoglobin \<6.2 mmol/L),
  • Active infection or sepsis,
  • Resting heart rate \> 110 beats per minute,
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days,
  • Recent myocardial infarction (within 3 months),
  • Transient case of AF (i.e., secondary to recent cardiac surgery (within 3 months)),
  • Planned cardioversion 30 days post implant of the WATCHMAN Device,
  • Implanted mechanical valve prosthesis,
  • History of obliterated LAA,
  • History of heart transplantation,
  • Symptomatic carotid disease (i.e., carotid stenosis \>50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months),
  • Necessity to use long-term OAC,
  • Contraindication for use of OAC or dual anti-platelet therapy,
  • Contraindication for use of aspirin,
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

  • Vroomen M, Maesen B, Luermans JG, Crijns HJ, Maessen JG, La Meir M, Pison L. Left Atrial Appendage Management with the Watchman Device during Hybrid Ablation of Atrial Fibrillation. J Interv Cardiol. 2019 Jun 26;2019:4525084. doi: 10.1155/2019/4525084. eCollection 2019.

    PMID: 31772531DERIVED

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Laurent Pison, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 15, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

NL(1)