BridgeMD
New treatment option for Atrial Fibrillation
Official title The CONFORM Pivotal Trial
ClinicalTrials.gov ID: NCT05147792
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or non-pregnant female aged ≥18 years
- Documented non-valvular AF (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
- Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
- Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral...
You likely can't join if
- Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing...
- Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk...
- Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol...
- A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis...
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
- Documented active systemic infection
See the full eligibility criteria
Who can join
- Male or non-pregnant female aged ≥18 years
- Documented non-valvular AF (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
- Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
- Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
- 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
- Able to comply with the protocol-specified medication regimen and follow-up evaluations
- 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...
What rules you out
- 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...
- 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...
- 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)
- 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)
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
- Documented active systemic infection
- 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...
- Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac treatment or surgical procedure
- Recent (within 30 days of index procedure) stroke or transient ischemic attack
- Recent (within 30 days of index procedure) myocardial infarction
- Vascular access precluding delivery of implant with catheter-based system
- Severe heart failure (New York Heart Association Class IV)
- Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
- Platelet count \ 700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3
- Known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or to device materials (e.g., nickel, titanium), or the subject has contrast sensitivity that...
- Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- Unable to undergo general anesthesia
- 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...
- A condition which precludes adequate transesophageal echocardiographic assessment Echo exclusion criteria:
- Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational...
- Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE
- Left ventricular ejection fraction (LVEF) \<30%
- Moderate or large pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
- Atrial septal defect that warrants closure
- High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \> 15 mm) or large shunt (early [within 3 beats] and/or substantial passage of bubbles, e.g., \>20)
- Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
- Evidence of cardiac tumor
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Jonesboro, Arkansas, United States
- Loma Linda, California, United States
- Pasadena, California, United States
- Santa Monica, California, United States
- Ventura, California, United States
- Littleton, Colorado, United States
- Bridgeport, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Largo, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
+ 60 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Jonesboro, Arkansas, United States; Loma Linda, California, United States and 74 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.