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Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET

ConditionsAtrial FibrillationStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation

About this trial

The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed curve sheath. In this study investigators aim to compare the outcome of patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath versus a novel steerable sheath.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patient been/being implanted with device other than Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Pregnant or breastfeeding patients

Prisoners

Patients not willing to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.

    Other intervention

    Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Patients with Amulet device using non-steerable fixed curve sheathNo intervention 0 interventions
Group B: Patients with Amulet device using a novel steerable sheathActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Acute Closure of Left Atrial Appendage

Acute closure ( less than or equal to 3mm) of the left atrial appendage after Left Atrial Appedage Occlusion(LAAO) procedure

Time frame
1 day
2

Number of patients with Cardiac Perforation

Number of patients with cardiac perforation

Time frame
7 days
3

Need for Pericardiocentesis

Need for pericardiocentesis within 7 days of implantation

Time frame
7 days

Secondary outcomes

1

Number of devices

Number of devices changed prior to final implant during the procedure

Time frame
1 day (procedure day)
2

Number of device repositions

Number of device repositions performed during the procedure

Time frame
1 day (procedure day)
3

Closure Rates

45 day closure rates of left atrial appendage ( less than or equal to 3mm)

Time frame
45 days
4

Number of participants with Device related thrombus (DRT)

Number of participants with Device related thrombus (DRT)

Time frame
45 days

Other outcomes

Sponsors and contacts

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

Kansas City Heart Rhythm Research Foundation

Lead sponsor

Kansas City Heart Rhythm Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: