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

NCT05464511 | Not Yet Recruiting

• 1 other identifier: KCHRRF-STEERRCLOSE-0015
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (3)

• 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

  1 day

• Number of patients with Cardiac Perforation

  Number of patients with cardiac perforation

  7 days

• Need for Pericardiocentesis

  Need for pericardiocentesis within 7 days of implantation

  7 days

Secondary Outcomes (5)

• Number of devices

  1 day (procedure day)

• Number of device repositions

  1 day (procedure day)

• Closure Rates

  45 days

• Number of participants with Device related thrombus (DRT)

  45 days

• Number of participants with Transient ischemic attack (TIA) or cerebrovascular accident (CVA)

  6 months

Study Arms (2)

Patients with Amulet device using non-steerable fixed curve sheath

NO INTERVENTION

Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath.

Patients with Amulet device using a novel steerable sheath

ACTIVE COMPARATOR

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

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

Interventions

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

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

Patients with Amulet device using a novel steerable sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with atrial fibrillation who meets the indication/criteria for left atrial appendage occlusion and undergoing implantation of Amplatzer™ Amulet™ Left Atrial Appendage Occluder device

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead
• Kansas City Heart Rhythm Institute: collaborator

Study Sites (7)

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Centerpoint Medical Center Clinic

Independence, Missouri, 64057, United States

Location

Centerpoint Medical Center

Independence, Missouri, 64057, United States

Location

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

Location

Research Medical Center

Kansas City, Missouri, 64032, United States

Location

Related Publications (5)

• Gangireddy SR, Halperin JL, Fuster V, Reddy VY. Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: an assessment of net clinical benefit. Eur Heart J. 2012 Nov;33(21):2700-8. doi: 10.1093/eurheartj/ehs292. Epub 2012 Sep 24.

  PMID: 23008509 BACKGROUND

• Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.

  PMID: 25399274 BACKGROUND

• Jazayeri MA, Vuddanda V, Parikh V, Lakkireddy DR. Percutaneous left atrial appendage closure: current state of the art. Curr Opin Cardiol. 2017 Jan;32(1):27-38. doi: 10.1097/HCO.0000000000000367.

  PMID: 27898435 BACKGROUND

• Lakkireddy D, Thaler D, Ellis CR, Swarup V, Sondergaard L, Carroll J, Gold MR, Hermiller J, Diener HC, Schmidt B, MacDonald L, Mansour M, Maini B, O'Brien L, Windecker S. Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. Circulation. 2021 Nov 9;144(19):1543-1552. doi: 10.1161/CIRCULATIONAHA.121.057063. Epub 2021 Aug 30.

  PMID: 34459659 BACKGROUND

• Saw J, Perrin N, Nestelberger T, Mondesert B, Tsang M, Ibrahim R. First-in-Human Experience With the Amplatzer Steerable Delivery Sheath for Left Atrial Appendage Closure. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2191-2193. doi: 10.1016/j.jcin.2021.07.022. No abstract available.

  PMID: 34620400 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Dhanunjaya Lakkireddy

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a multi-centered, retrospective as well as prospective observational registry with patients undergoing LAAO with the dual mechanism closure Amulet device. This study will proceed with a target of 300 patients who have undergone or are planned to undergo LAAO with dual mechanism closure Amulet device. Patient level data of participating centers will be obtained from National Cardiovascular Data Registry (NCDR®) of patients who have already had the procedure. Prospective data will be collected for all patients willing to participate in the study.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 19, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)