Health TrialsbyHealthPanel

The CONFORM Pivotal Trial

ConditionsAtrial FibrillationStroke
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CLAAS

    Device

    CLAAS

  • WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

    Device

    WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: CLAASExperimental treatment 1 intervention
Group B: WATCHMAN / AmuletActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Procedure-related complications, all-cause death, major bleeding

The primary safety endpoint is a composite of 1) major procedure-related complications including a) cardiac perforation, b) pericardial effusion requiring drainage, c) ischemic stroke, d) device embolization, and e) major vascular complications, or 2) major bleeding, or 3) all-cause death

Time frame
12 months
2

Ischemic stroke and systemic embolism

The primary effectiveness endpoint is a composite of ischemic stroke and systemic embolism through 18 months.

Time frame
18 months

Secondary outcomes

1

Procedure-related complications, all-cause death, major bleeding

All elements of the Primary Safety Endpoint will be reported descriptively for all subjects through 5 years: a composite of 1) major procedure-related complications including a) cardiac perforation, b) pericardial effusion requiring drainage, c) ischemic stroke, d) device embolization, and e) major vascular complications, or 2) major bleeding, or 3) all-cause death

Time frame
5 years
2

Device Success

A secondary performance and efficacy endpoint is Device Success, defined as LAAO device deployed and implanted in correct position

Time frame
Procedure
3

Technical success

A secondary performance and efficacy endpoint is Technical Success, defined as Device Success, complete closure or peri-device residual leak ≤5 mm in width on TEE, as evaluated by independent imaging core lab without device-related complications \[evaluated post-procedure\].

Time frame
45 days
4

Procedure success

A secondary performance and efficacy endpoint is Procedure Success, defined as Technical Success without in-hospital major procedure-related complications (excluding minor device embolization) evaluated at hospitalization or at 7 days whichever is first.

Time frame
7 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Conformal Medical, Inc

Lead sponsor

Source ClinicalTrials.gov
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