Stroke Feasibility Study

NCT01997905 | Completed Phase 1 Results

• 1 other identifier: CP2011-2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 7

Brief Summary

This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.

Conditions

Atrial Fibrillation; AFib

Keywords

Left Atrial Appendage; LAA; Atrial Fibrillation; AFib; AF; IRB approved; clinical; Stroke; TIA; contraindication to oral anticoagulation therapy; Arrhythmias, Cardiac; OAC; trial; study; LAA occlusion; occluded; prevent

Outcome Measures

Primary Outcomes (2)

• Number of Serious Adverse Events Within 30 Days Post-Index Procedure

  The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator: * Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip * Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke * Major bleeding (defined as requiring re-operation and/or transfusion (\> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure).

  30 days post-index procedure

• Composite Left Atrial Appendage Placement and Exclusion Success

  Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following: 1. Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient. 2. Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \<10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE. 3. 3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (\<3 mm residual communication with LAA and \< 10mm residual pocket) between the LA and LAA at \>=3 month TEE or CTA evaluation.

  Immediate to 3-months post-index procedure

Secondary Outcomes (4)

• Rate of Stroke and Non-CNS Systemic Embolism

  3 months and 6 months post-index procedure

• Serious Device or Procedure Related Adverse Event Rate

  3 month and 6 month post-index procedure

• Overall Serious Adverse Event Rate

  3 month and 6 month Post Index Procedure

• Overall Adverse Event Rate

  3 month and 6 month post-index procedure

Study Arms (1)

AtriClip LAA Exclusion Device

EXPERIMENTAL

AtriClip delivered via minimally invasive surgical procedure

Device: AtriClip LAA Exclusion Device

Interventions

AtriClip LAA Exclusion Device DEVICE

Also known as: LAAØ, PRO1, AtriClip™ LAA Exclusion System, AtriClip™ LAA Exclusion System w/ preloaded Gillinov-Cosgrove™ Clip, AtriClip LAA Exclusion System and Delivery System (LAAØ), AtriClip LAA Exclusion System and Delivery System (PRO1)

AtriClip LAA Exclusion Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years and ≤ 80 years of age.
• Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
• CHADS2 or CHA2DS2VASc score ≥2.
• Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following:
• history of intracranial bleeding (e.g. due to amyloid angiopathy or other condition) which renders patient unsafe for OAC;
• history of gastrointestinal, genitourinary, or respiratory tract bleeding due to permanent condition which renders patient unsafe for OAC;
• HAS-BLED Score ≥ 3.
• Patient is considered an acceptable surgical candidate, including use of general anesthesia.
• Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.

You may not qualify if:

• Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure.
• Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax.
• Myocardial infarction within 60 days prior to index procedure.
• NYHA Class IV heart failure.
• Ejection fraction \< 40% (based on baseline transthoracic echocardiography (TTE)).
• Prior attempted obliteration of left atrial appendage (percutaneous or open cardiac surgery).
• Previous catheter ablation with perforation or complication.
• Prior open cardiac surgery, or percutaneous coronary intervention with associated unintended cardiac perforation, or pericardial adhesions are suspected.
• History of pericarditis or pericardiocentesis.
• Active infection, septicemia, or fever of unknown origin.
• Concomitant elective surgical procedure (in addition to AtriClip placement) at the time of index procedure.
• Planned atrial arrhythmia ablation procedure within six months following index procedure.
• Underlying structural heart disease requiring planned surgical treatment within six months following the index procedure.
• Cardiac or thoracic surgical procedure within the thirty days prior to index procedure.
• Anticoagulation therapy for other medical condition (i.e. deep vein thrombosis) is required.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (7)

St. Helena Hospital

St. Helena, California, 94574, United States

Location

Mercy Hospital

Miami, Florida, 33133, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Aspirus

Wausau, Wisconsin, 54401, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Arrhythmias, Cardiac; Bites and Stings

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Results Point of Contact

• Title: Basel Ramlawi, MD
• Organization: Methodist Hospital Houston

basel.ramlawi@gmail.com

713-441-5200

Study Officials

• Basel Ramlawi, MD

  Methodist Hospital Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 28, 2013
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 14, 2016
• Results First Posted: October 21, 2016

Record last verified: 2016-10

Locations

US (7)