Coherex WAVECREST I Left Atrial Appendage Occlusion Study

NCT02239887 | Completed

• 1 other identifier: IP005
• Study Type: observational
• Target: 155
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at increased risk for embolic stroke and have an ongoing indication for oral anticoagulation.

Conditions

Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation; LAA Anatomy Amenable to Treatment by Percutaneous Technique; Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium

Keywords

LAA occlusion; Non-valvular Atrial Fibrillation; Percutaneous; Oral Anticoagulation; Occluder; WAVECREST

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  The primary safety endpoint is the incidence of major adverse events up to 45 days post-procedure. Major adverse events are defined as life-threatening incidents as determined by the Clinical Events Committee (CEC) and include events such as device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; or any other event related to the device or the procedure, which requires treatment.

  45 Days post procedure

• Primary Efficacy Endpoint

  The primary efficacy endpoint is the incidence of LAA occlusion at 45 and/or 180 days (+ten days) post-procedure. LAA occlusion will be assessed by transesophageal echocardiography (TEE) color flow Doppler and will be defined as absence of flow in the LAA or color flow Doppler jets less than 3mm.

  45 and/or 180 days post procedure

Secondary Outcomes (2)

• Secondary Safety Endpoint

  180 days and one year post-procedure

• Secondary Efficacy Endpoints

  intra operative

Study Arms (1)

WaveCrest LAA occlusion device

Left Atrial Occlusion

Device: WaveCrest LAA occlusion device

Interventions

WaveCrest LAA occlusion device DEVICE

Left Atrial Appendage Occlusion

WaveCrest LAA occlusion device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is the subset of patients who have non-valvular paroxysmal, persistent, or permanent atrial fibrillation; LAA anatomy amenable to treatment by percutaneous techniques; and an anticoagulation indication for potential thrombus formation in the left atrium. Patients with an absolute or relative contraindication to anticoagulants will also be included.

You may qualify if:

• At least 18 years of age.
• Diagnosis of paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
• Indicated for long-term anticoagulation therapy including patients on anticoagulants and patients with a contraindication to anticoagulation. The first 30 patients must have a contraindication to anticoagulation.
• Eligible for cessation of anticoagulation therapy if the LAA is sealed (i.e., the patient has no other condition requiring anticoagulation therapy).
• Calculated CHADS score ≥ 1.
• Willingness to participate in the required follow-up visits and tests.
• Willingness of patient or legal representative to provide written informed consent.
• Female subjects of child-bearing potential must have a negative serum pregnancy test within 7 days prior to the index procedure, and must be willing to use reliable contraception methods for one year post-procedure.

You may not qualify if:

• Known contraindication and/or allergy to aspirin, clopidogrel, IV contrast, or nickel.
• Extensive congenital cardiac anomalies, which can only be adequately repaired by cardiac surgery.
• Stroke or transient ischemic attack (TIA), as diagnosed by a neurologist, within the past 30 days. Patients with a history of stroke or TIA will not be allowed to enroll until 30 days post stroke or TIA have been completed.
• New York Heart Association Class IV Congestive Heart Failure, defined as patients with severe physical limitations and symptoms even while at rest.
• Myocardial infarction within the past three months.
• Sepsis within one month prior to implantation or any systemic infection that cannot be successfully treated prior to device placement.
• Presence of an atrial septal defect, atrial septal repair, or atrial septal closure device.
• Female subjects who may be pregnant or are planning on becoming pregnant in the next year.
• Cardioversion or ablation procedure planned in conjunction with or within 30 days after placement of the Coherex WaveCrest Left Atrial Appendage Occlusion System.
• Cardiac transplant or mechanical valve.
• Symptomatic carotid artery disease.
• Any medical disorder or psychiatric illness that would interfere with successful completion of the study as determined by the investigator.
• Conditions other than atrial fibrillation requiring long-term warfarin therapy.
• Resting heart rate \> 110 beats per minute (bpm).
• A single episode of transient atrial fibrillation.

Sponsors & Collaborators

• Coherex Medical: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: October 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01