Assessment of the WATCHMANTM Device in Patients Unsuitable for Oral Anticoagulation ASAP-TOO

  • STATUS
    Recruiting
  • sponsor
    Genzyme Corporation
Updated on 3 December 2020
aspirin
stroke
heart failure
atrial fibrillation
ticagrelor
vascular disease
cardioversion
anticoagulation therapy

Summary

Assessment of the WATCHMANTM Device in Patients Unsuitable for Oral Anticoagulation ASAP-TOO

Description

This study is a prospective, randomized, multi-center, global investigation to determine the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anticoagulation therapy to reduce the risk of stroke.

The cohort of subjects for inclusion in this study is symptomatic as a result of their persistent atrial fibrillation and the failure of class I or III antiarrhythmic drug therapy. Phased RF ablation therapy offers the opportunity to reduce the episodes of atrial fibrillation and therefore reduce symptoms. Catheter ablation therapy in subjects with paroxysmal atrial fibrillation have shown improvements in symptoms and reduced episodes of atrial fibrillation.

In the United States there are no approved ablation catheters approved to treat subjects with persistent atrial fibrillation. If successful, the VICTORY AF study could demonstrate meaningful therapeutic benefit in this underserved population. In Europe, Phased RF ablation catheters are approved to treat subjects with persistent atrial fibrillation. If successful, the VICTORY AF study could confirm meaningful therapeutic benefit in this underserved population.

Details
Condition Atrial Fibrillation, Atrial Fibrillation (Pediatric)
Clinical Study IdentifierTX149654
SponsorGenzyme Corporation
Last Modified on3 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have any of these conditions: Atrial Fibrillation or Atrial Fibrillation (Pediatric)?
The subject is of legal age to participate in the study per the laws of their respective geography
The subject has documented paroxysmal, persistent, permanent or longterm/ longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)
The subject has a calculated CHA2DS2-VASc score of 2 or greater
The subject is deemed by two study physicians to be unsuitable for oral anticoagulation
The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant
The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
The subject is able and willing to return for required follow-up visits and examinations
Ticagrelor or prasugrel may be used in place of clopidogrel if subject has another indication or a known resistance to clopidogrel. Prasugrel should only be used if neither clopidogrel nor ticagrelor can be used due to potential for increased bleeding risk

Exclusion Criteria

The subject is unable or unwilling to return for required follow-up visits and examinations
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation)
The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery)
The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization
The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event
The subject has a history of atrial septal repair or has an ASD/PFO device
The subject has an implanted mechanical valve prosthesis in any position
The subject suffers from New York Heart Association Class IV Congestive Heart Failure
The subject has LVEF < 30%
The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion)
The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility
The subject has a life expectancy of less than two years
The subject has a known or suspected hypercoagulable state
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