RECRUITING

The CONFORM Pivotal Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.

Official Title

An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion

Quick Facts

Study Start:2022-05-26

Study Completion:2031-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05147792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or non-pregnant female aged ≥18 years 2. Documented non-valvular AF (paroxysmal, persistent, or permanent) 3. High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3 4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation 5. Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy. 6. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care 7. Able to comply with the protocol-specified medication regimen and follow-up evaluations 8. The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).	1. Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure. 2. Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure) 3. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) 4. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve) 5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated 6. Documented active systemic infection 7. Symptomatic carotid artery 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 noted at the site of prior treatment 8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure 9. Recent (within 30 days of index procedure) stroke or transient ischemic attack 10. Recent (within 30 days of index procedure) myocardial infarction 11. Vascular access precluding delivery of implant with catheter-based system 12. Severe heart failure (New York Heart Association Class IV) 13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant 14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation) 15. Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3 16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated 17. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial 18. Unable to undergo general anesthesia 19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years 20. A condition which precludes adequate transesophageal echocardiographic assessment

Inclusion Criteria

Exclusion Criteria

1. Male or non-pregnant female aged ≥18 years
2. Documented non-valvular AF (paroxysmal, persistent, or permanent)
3. High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
5. Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
6. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care
7. Able to comply with the protocol-specified medication regimen and follow-up evaluations
8. The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).

1. Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
2. Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure)
3. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
4. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)
5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
6. Documented active systemic infection
7. Symptomatic carotid artery 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 noted at the site of prior treatment
8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
9. Recent (within 30 days of index procedure) stroke or transient ischemic attack
10. Recent (within 30 days of index procedure) myocardial infarction
11. Vascular access precluding delivery of implant with catheter-based system
12. Severe heart failure (New York Heart Association Class IV)
13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
15. Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3
16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated
17. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
18. Unable to undergo general anesthesia
19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years
20. A condition which precludes adequate transesophageal echocardiographic assessment

Contacts and Locations

Study Contact

Aly Dechert, MS

CONTACT

603-718-8742

adechert@conformalmedical.com

Principal Investigator

William Gray, M.D.

PRINCIPAL_INVESTIGATOR

Lankenau Heart Institute

Shephal Doshi, M.D.

PRINCIPAL_INVESTIGATOR

Pacific Heart Institute

Study Locations (Sites)

Grandview Medical Center

Birmingham, Alabama, 35243

United States

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016

United States

HonorHealth

Scottsdale, Arizona, 85258

United States

Pima Heart & Vascular

Tucson, Arizona, 85719

United States

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401

United States

Pacific Heart Institute

Santa Monica, California, 90405

United States

Community Memorial Hospital Ventura

Ventura, California, 93003

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

Ascension St. Vincent's Jacksonville

Jacksonville, Florida, 32204

United States

Largo Medical Center

Largo, Florida, 33770

United States

Baptist Hospital of Miami

Miami, Florida, 33176

United States

USF - Tampa General Hospital

Tampa, Florida, 33620

United States

Piedmont Health Institute

Atlanta, Georgia, 30309

United States

Emory University

Atlanta, Georgia, 30342

United States

Northside Hospital, Inc

Atlanta, Georgia, 30342

United States

WellStar Kennestone Hospital

Marietta, Georgia, 30062

United States

Ascension St. Vincent - Carmel, IN

Indianapolis, Indiana, 46260

United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226

United States

Terrebone - Cardiovascular Institute of the South

Houma, Louisiana, 70360

United States

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218

United States

Lahey Hospital & Medical Centeer

Burlington, Massachusetts, 01805

United States

Baystate Medical Center

Springfield, Massachusetts, 01199

United States

Henry Ford St. John Hospital

Detroit, Michigan, 48236

United States

Corewell Health

Grand Rapids, Michigan, 49503

United States

Henry Ford Providence Southfield Hospital

Southfield, Michigan, 48075

United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303

United States

North Mississippi Medical Center

Tupelo, Mississippi, 38801

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

United States

Kansas City Cardiac Arrhythmia Research, LLC

Overland, Missouri, 66211

United States

Catholic Medical Center

Manchester, New Hampshire, 03102

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Cooper University - Heart House

Haddon Heights, New Jersey, 08104

United States

University of Buffalo / Kaleida Health

Buffalo, New York, 14203

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Mission Hospital

Asheville, North Carolina, 28801

United States

Ohio Health Research Institute

Columbus, Ohio, 43214

United States

Lankenau Heart Institute

Wynnewood, Pennsylvania, 19096

United States

Lifespan Health System

Providence, Rhode Island, 02903

United States

Trident Medical Center

North Charleston, South Carolina, 29406

United States

Erlanger Health System

Chattanooga, Tennessee, 37403

United States

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77094

United States

Senatra Norfolk

Norfolk, Virginia, 23507

United States

Chippenham Hospital

Richmond, Virginia, 23225

United States

Carilion Clinic

Roanoke, Virginia, 24014

United States

West Virginia University

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Conformal Medical, Inc

William Gray, M.D., PRINCIPAL_INVESTIGATOR, Lankenau Heart Institute
Shephal Doshi, M.D., PRINCIPAL_INVESTIGATOR, Pacific Heart Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-26

Study Completion Date2031-12

Study Record Updates

Study Start Date2022-05-26

Study Completion Date2031-12

Terms related to this study

Additional Relevant MeSH Terms

Atrial Fibrillation
Stroke