Clinical Trials

  

Trials Currently Enrolling

PINNACLE FLX Clinical Study

The PINNACLE FLX US IDE Trial was designed to establish the Procedural Safety and LAA Closure Efficacy with the WATCHMAN FLX LAAC Device.

CHAMPION‑AF

Randomized, WATCHMAN FLX vs. NOACs in a broader NVAF population, inclusive of lower risk patients

ASAP-TOO Clinical Trial

If you have patients that cannot take OACs, learn about our latest clinical trial ASAP-TOO.

Learn more:

Holmes, D. R., et al. (2017). "The Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) trial." American Heart Journal 189: 68-74.

  

OPTION Clinical Trial

If you have patients that have had, or will have, an AF ablation and would like a non-pharmacological option for stroke risk reduction post-ablation, they may be eligible to participate in our OPTION trial. 

First three-year data from NCDR-LAAO Registry

The NCDR-LAAO Registry analysis is a review of the first three years and over 38,000 WATCHMAN implants.  This analysis, The NCDR Left Atrial Appendage Occlusion (LAAO) RegistryTM: Review of the First 3 Years, presented by Dr. James Freeman on March 29, 2020 at the ACC 2.0/WCC Virtual Experience. This analysis demonstrates that major in-hospital adverse event rates were in-line with those reported in the pivotal WATCHMAN device trials.

Learn More:

Freeman et al, The NCDR Left Atrial Appendage Occlusion (LAAO) Registry™: Review of the First 3 Years, JACC, March 2020

Long-Term Patient-Level Meta-Analysis

Five year results from a patient-level meta-analysis of the totality of data available on the WATCHMAN Device, by Reddy, et al, has been published in the Journal of American College of Cardiology (JACC). This publication includes 5-year outcomes of PREVAIL, combined with the 5-year outcomes of PROTECT-AF, and demonstrated that LAAC with Watchman provided stroke reduction in non-valvular atrial fibrillation comparable to warfarin with additional reductions in major bleeding and mortality. 

Learn More:

Reddy VY, et al. JACC 2017; 70(24): 2964-2975.

Initial Commercial Experience Data

Post-FDA Approval, Initial US Clinical Experience with Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Initial US Clinical Experience evaluates the acute procedural performance and complication rates for all WATCHMAN cases performed in the US since FDA approval.

The authors conclude that despite a large fraction of previously-inexperienced operators, in the real-world post-FDA approval experience of WATCHMAN LAAC, procedural success was high and complication rates low.

Learn More:

Reddy VY, et al. JACC 2017; 69(3): 253-261.

  

CAP 2 Registry

The Continued Access to PREVAIL (CAP2) Registry is a multi-center prospective non-randomized study allowing continued access to the WATCHMAN Device, following the PREVAIL trial, during regulatory review of the pre-market application for the WATCHMAN Device. The primary objective of the CAP2 registry was to collect additional safety and effectiveness data on the WATCHMAN Device in patients with non-valvular atrial fibrillation who are deemed by their physicians to be suitable for warfarin therapy.

  

PREVAIL Clinical Trial

The goal of the PREVAIL trial was to assess the safety and efficacy of LAA closure for stroke risk reduction in patients with NVAF compared with long-term warfarin therapy.

The authors concluded that in this trial, LAA occlusion was non-inferior to warfarin for ischemic stroke risk reduction or SE >7 days’ post-procedure. Although non-inferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety was significantly improved. This trial provided additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke risk reduction in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy.

Learn More:

Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the WATCHMAN Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL Trial. J Am Coll Cardiol. 2014;64(1):1-12.

  

CAP Registry

The Continued Access to PROTECT AF (CAP) Registry was a multi-center prospective non-randomized study allowing continued access to the WATCHMAN Device, following the PROTECT AF trial, during regulatory review of the pre-market application for the WATCHMAN Device. 

The primary objective of the CAP registry was to collect additional safety and effectiveness data on the WATCHMAN Device in subjects with non-valvular atrial fibrillation who are deemed by their physicians to be suitable for warfarin therapy.

  

PROTECT AF Clinical Trial

The multicenter PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appendage closure with a filter device (Watchman) was non-inferior to warfarin for stroke risk reduction in atrial fibrillation.

In the Journal of the American Medical Association article (4-year results), the authors concluded that after 3.8 years of follow-up among patients with non-valvular AF at elevated risk for stroke, percutaneous LAA closure met criteria for both non-inferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as superiority for cardiovascular and all-cause mortality.

Learn More:

Reddy VY, Sievert H, Halperin J, et al; for the PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988-1998. 

  

Pilot Study

Meta-analyses confirmed that in cases of left atrial thrombus in non-rheumatic AF patients approximately 90% of them are in the left atrial appendage (LAA).  This study assessed the feasibility of implanting a device in the LAA in patients with atrial fibrillation (AF) to prevent thromboembolic stroke.

The authors concluded that preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible. 

Learn More:

Sick PB, Schuler G, Hauptmann KE, et al. Initial worldwide experience with the WATCHMAN Left Atrial Appendage System for stroke prevention in atrial fibrillation. J Am Col Cardiol. 2007;49(13):1490-1495.

WATCHMAN device

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.​

INDICATIONS FOR USE​

The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:​

  • Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;​
  • Are deemed by their physicians to be suitable for anticoagulation therapy; and​
  • Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.

CONTRAINDICATIONS

Do not use the WATCHMAN® Device if:​

  • Intracardiac thrombus is present.​
  • An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is​ present.​
  • The LAA anatomy will not accommodate a device. See Table 45 (in the IFU).​
  • The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section in the IFU) such that the use of the WATCHMAN device is contraindicated.​
  • Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.​
  • There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. ​

WARNINGS

Implantation of the WATCHMAN Device should only be performed by interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures and who have completed the WATCHMAN Physician Training program.​

  • This device has not been studied in pregnant or breastfeeding women. Careful consideration should be given to use of the Closure Device in pregnant and/or breastfeeding women due to the risk of significant exposure to x-rays and the use of anticoagulation medicine.​
  • Device selection should be based on accurate LAA measurements obtained using echocardiographic imaging guidance (TEE recommended in multiple angles [e.g., 0º, 45º, 90º, 135º]) to avoid improper Closure Device sizing.​
  • Do not release (i.e., unscrew) the WATCHMAN Device from the core wire unless all release criteria are satisfied to avoid suboptimal results.​
  • Potential for Closure Device embolization exists with cardioversion <30 days following Closure Device​ implantation; verify Closure Device position post-cardioversion during this period.​
  • Appropriate post-procedure drug therapy should be followed. See Post-Procedure Information section​ (in the IFU) for further detail. ​

PRECAUTIONS

  • The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.​
  • The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying the Closure​ Device
  • Use caution when introducing a WATCHMAN Access System to prevent damage to cardiac structures.​
  • Use caution when introducing the Delivery System to prevent damage to cardiac structures.​
  • To prevent damage to the Delivery Catheter or Closure Device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath.​
  • If using a power injector, the maximum pressure should not exceed 100 psi.​

PATIENT SELECTION FOR TREATMENT

In considering the use of the WATCHMAN FLX Device, the rationale for seeking an alternative to long-term anticoagulation therapy and the safety and effectiveness of the device compared to anticoagulation should be taken into account.​

  • The presence of indication(s) for long-term anticoagulation therapy, other than non-valvular atrial​ fibrillation (e.g. mechanical heart valve, hypercoagulable states, recurrent deep venous thrombosis).

Details regarding the indications, contraindications, warnings, and precautions for oral anticoagulants approved for patients with non-valvular atrial fibrillation are provided in their respective Instructions for Use. Of note:​

  • The safety and effectiveness (and benefit-risk profile) of the WATCHMAN FLX Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.​
    Factors that need to be considered for the WATCHMAN FLX Device and implantation procedure include​ the following:​
    • Overall medical status, including conditions which might preclude the safety of a percutaneous, transcatheter procedure.​
    • Suitability for percutaneous, transseptal procedures, including considerations of:​
      • Cardiac anatomy relating to the LAA size and shape.​
      • Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity).​
      • Ability of the patient to tolerate general or local anesthesia.​
      • Ability of the patient to undergo required imaging.​
    • Ability to comply with the recommended post-WATCHMAN FLX Device implant pharmacologic regimen (see Post-Procedure Information section in the eIFU) especially for patients at high risk for bleeding.​

ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:​
Air embolism, Airway trauma, Allergic reaction to contrast media, anesthetic, WATCHMAN Implant material, or medications, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, Bruising, hematoma or seroma near the catheter insertion site, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Death, Decreased hemoglobin, Deep vein thrombosis, Device embolism, Device fracture, Device thrombosis, Edema, Embolism, Excessive bleeding, Fever, Fistula, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection/pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device/improper seal of the appendage/movement of device from appendage wall, Myocardial erosion, Nausea, Oral bleeding, Pericardial effusion/tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency/failure, Stroke – Hemorrhagic, Stroke – Ischemic, Surgical removal of the device, TEE complications (e.g., throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular or vascular damage, Vasovagal reactions​

There may be other potential adverse events that are unforeseen at this time.​

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