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WATCHMAN Implantation During Hybrid Ablation (WINNING)

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ClinicalTrials.gov Identifier: NCT02471131
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Device: WATCHMAN Device implantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WATCHMAN LAAC Device Implantation During Hybrid Atrial Fibrillation Ablation
Study Start Date : October 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: WATCHMAN Implantation Device: WATCHMAN Device implantation
The implantation of the device will be done into the left atrial appendage according to the guidelines.




Primary Outcome Measures :
  1. Major complications during follow-up, assessed by scoring the number of complications [ Time Frame: 6 months ]
  2. Device success, assessed by transesophageal echocardiogram. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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,
  • 18 years of age or older, able and willing to provide written informed consent.

Exclusion Criteria:

  • 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,
  • Pregnancy or planned pregnancy during the course of the investigation,
  • Life expectancy less than 2 years,
  • Participation in any other clinical study involving an investigational drug or device.

Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:

  • Left ventricular ejection fraction (LVEF) < 30%,
  • Intracardiac thrombus as visualized by TEE within 2 days prior to implant,
  • High risk patent foramen ovale,
  • Current atrial septal defect and/or previous atrial septal repair or closure device,
  • Significant mitral valve stenosis (i.e., MV 4. 5 cm2),
  • Existing pericardial effusion of >3 mm,
  • Complex atheroma with mobile plaque of the descending aorta and/or aortic arch,
  • Cardiac tumor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471131


Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229HX
Sponsors and Collaborators
Maastricht University Medical Center
Boston Scientific Corporation
Investigators
Principal Investigator: Laurent Pison, MD, PhD Maastricht University Medical Center

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02471131     History of Changes
Other Study ID Numbers: NL.53510.068.15
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Maastricht University Medical Center:
WATCHMAN
Atrial Fibrillation
Hybrid Ablation
Safety
Feasibility
Stroke Prevention

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes