The CONFORM Pivotal Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConformal Medical, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
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)
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)
Trial design
Treatments tested in this trial
- CLAAS
- WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
Treatment groups
1,600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov