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Atrial FibrillationCAP2NCT01760291

Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology

A study testing WATCHMAN LAA Closure Technology in people with Atrial Fibrillation, run by Boston Scientific Corporation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure Technology Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
WATCHMAN LAA Closure Technology
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
576 participants
Where
3 sitesUnited States
Study dates
Sep 2012to Apr 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Subjects will be excluded from the study if they meet any of the following criteria:
  • The subject requires long-term warfarin therapy (i.e., even if the device is implanted, the subjects would not be eligible to discontinue warfarin due to other medical conditions requiring chronic warfarin therapy). Additionally, a subject with any of the following is excluded:
  • Thrombosis occurring at a young age (<40 years old)
  • Idiopathic or recurrent venous thromboembolism
  • Thrombosis at an unusual site (i.e., cerebral veins, hepatic veins,renal veins, inferior vena cava, mesenteric veins)
  • Family history of venous thromboembolism or of inherited prothrombotic disorder
Show all 39Show fewer
  • Recurrence or extension of thrombosis while adequately anticoagulated
  • The subject is contraindicated for warfarin therapy or cannot tolerate long-term warfarin therapy
  • The subject is contraindicated or allergic to aspirin
  • The subject is indicated for antiplatelet therapy other than aspirin (for example, a subject indicated for clopidogrel, prasugrel, ticlopidine or ticagrelor due to DES is excluded from enrollment during the dosing regimen). A subject completing a course of antiplatelet therapy may be enrolled after a 7 day washout period
  • The subject had any interventional or surgical procedure within 30 days prior to enrollment or is planning to have an interventional or surgical procedure in the time between the WATCHMAN device implant and 45-day TEE (e.g., cardioversion, ablation, cataract surgery, dental surgery)
  • The subject had a prior stroke or TIA within the 90 days prior to enrollment
  • The subject has had an MI within 90 days prior to enrollment
  • The subject has a history of atrial septal repair or has an ASD/PFO device
  • The subject has an implanted mechanical valve prosthesis
  • The subject suffers from New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
  • The subject has symptomatic carotid disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is < 50% stenosis
  • The subject's AF is defined by a single occurrence of AF
  • The subject had a transient case of AF (i.e., secondary to CABG, interventional procedure, etc.)
  • The subject's left atrial appendage is obliterated
  • The subject has undergone heart transplantation
  • The subject is currently treated with antibiotics for an active infection
  • The subject has a resting heart rate > 110 bpm
  • The subject has thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e., anemia as determined by the investigator which would require transfusion)
  • The subject is actively enrolled in a concurrent clinical study of an investigational drug or investigational device (study specifics may be reviewed with the sponsor prior to enrollment to confirm a concurrent study will not interfere with the outcomes of this study)
  • The subject participated in any of the following studies: PROTECT AF, CAP Registry, or PREVAIL. If the subject received a subject ID number for a prior WATCHMAN study, the subject may not be enrolled. PROTECT AF control subjects may be considered for participation if they have completed 5 year follow up
  • The subject is pregnant or pregnancy is planned during the course of the investigation
  • The subject has a life expectancy of less than two years
  • The subject is unable to complete follow-up visits for the duration of the study
  • Echo Exclusion Criteria
  • A subject is excluded from the study if any of the following echocardiographic exclusion criteria (as assessed via TTE and TEE) are met:
  • The subject has LVEF < 30%
  • The subject has intracardiac thrombus or dense spontaneous echo contrast as visualized by TEE and determined by the echocardiographer within 2 days prior to implant
  • The subject has an existing pericardial effusion > 2mm
  • The subject has a high risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm
  • The subject has a high risk PFO with a large shunt defined as early, within 3 beats or substantial passage of bubbles
  • The subject has significant mitral valve stenosis (i.e., MV <1.5 cm2)
  • The subject has complex atheroma with mobile plaque of the descending aorta or aortic arch
  • The subject has a cardiac tumor

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Arizona Heart Rhythm Research Center

    Phoenix, Arizona, 85006

Other trials in United States

About this study

Official title: Continued Access to PREVAIL (CAP2)- WATCHMAN Left Atrial Appendage (LAA) Closure Technology

To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure Technology

Read the detailed description

This Continued Access Protocol is a prospective, non-randomized, multicenter study to allow continued access to the WATCHMAN LAA Closure Technology during the data analysis, reporting and review of the PREVAIL pivotal study Pre-Market Application by FDA.

Being tested
WATCHMAN LAA Closure Technology
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATCHMAN LAA Closure TechnologyDevice

Study groups in NCT01760291
Study groupRoleWhat they receive
WATCHMANExperimentalWATCHMAN LAA Closure Technology
Receives: Device: WATCHMAN LAA Closure Technology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Ischemic Stroke

    Primary Endpoint Events by Type for Enrolled Subjects

    Measured: 5 Year Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionApr 2019
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01760291
Sponsor's protocol ID
S2278
Acronym
CAP2
Status last verified
Mar 2022
First submitted
6 Nov 2012
Last updated
29 Mar 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35902169

Questions about this trial

What is this clinical trial studying?

A study testing WATCHMAN LAA Closure Technology in people with Atrial Fibrillation, run by Boston Scientific Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Ischemic Stroke (time frame: 5 Year Follow Up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01760291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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CAP2 Clinical Trial NCT01760291 | AzTrials