CLIP-IT Post-Market Study

Left Atrial Appendage Exclusion Clinical Trial

Official title:

exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203054
• Other study ID #: MDT22049
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: February 2029

Study information

• Verified date: June 2024
• Source: Medtronic Cardiac Surgery
• Contact: Morgan Judkins
• Phone: +17635149752
• Email: morgan.l.judkins[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ LAA Exclusion System in subjects undergoing concomitant cardiac surgery.

Description:

Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ LAA Exclusion Clip at up to 25 sites in the United States.

Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2029
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is indicated to be treated with the Penditure™ LAA Exclusion System

• Greater than or equal to 18 years of age

• The subject is willing and able to provide written informed consent and comply with study visit requirements

Exclusion Criteria:

• Prior LAA isolation attempt(s)

• Need for emergent cardiac surgery

• Subject is contraindicated for MDCT and/or TEE

• Life expectancy of less than 12 months

• History of cardiac surgery

• Pericarditis

• Presence of thrombus in the left atrium or LAA, prior to or during the procedure

• Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest

• NYHA Class IV heart failure symptoms

• Patient has a documented history of substance (drug or alcohol) abuse

• Known allergy to device components (Nickel and/or Titanium)

• In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions

• Currently participating in an investigational drug or another device trial or study (excluding registries)

Related Conditions & MeSH terms

• Left Atrial Appendage Exclusion

Intervention

Device:
• Penditure™ LAA Exclusion System
Exclusion of the left atrial appendage using the Penditure™ LAA Exclusion System in subjects undergoing concomitant cardiac surgery.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Corewell Health	Grand Rapids	Michigan
United States	UPMC Pinnacle Harrisburg Campus	Harrisburg	Pennsylvania
United States	Mayo Clinic Saint Marys Campus	Rochester	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful exclusion of the LAA from the heart	The primary efficacy endpoint is the rate of successful exclusion of the LAA from the heart defined as the absence of residual communication (= 3 mm residual communication) between the left atrium (LA) and the LAA. For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan.	3 months post procedure
Primary	Rate of device related adverse events	The primary safety endpoint is the composite rate of device related adverse events at 30-days post-procedure.	30 days post procedure
Secondary	Rate of successful placement of the Penditure™ LAA Exclusion System	The secondary efficacy endpoint is defined as the rate of successful placement of the Penditure™ LAA Exclusion System defined as < 10 mm of residual stump proximal to the clip at the time of the procedure (measured by intraoperative TEE with doppler) without tissue damage requiring intervention.	At the time of procedure
Secondary	Rate of device related adverse events	The secondary safety endpoint is defined as the composite device related adverse event rate at 12-months and annually through 36 months.	At 1 year, 2 year, and 3 years post procedure