Left Atrial Appendage Incomplete ClosureTREASURENCT03503253
Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
A study testing Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System and Azur Peripheral Coil System in people with Left Atrial Appendage Incomplete Closure, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Incomplete Closure
- What is being tested?
- Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System and Azur Peripheral Coil System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years.
- Presence of a significant LAA leak (moderate/severe following percutaneous occlusions or mild/severe after epicardial exclusions with the LARIAT suture delivery device).
- Less moderate embolic risk (CHA2DS2-VASc ≥2)
- High associated hemorrhagic risk (HASBLED ≥ 3), or absolute contraindication to OAC, or need for prolonged dual antiplatelet therapy, or history of thromboembolic events despite LAA occlusion/exclusion after other potential causes.
- written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Who cannot join
- Life expectancy < 2 years.
- pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78705
Andrea Natale, 512-784-2651, andrea.natale@stdavids.com
About this study
Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with detachable vascular coils.
Read the detailed description
Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-indications. Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete LAA closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. To date, detachable coils have found a wide range of applications for transcatheter occlusion/embolization procedures (e.g., cerebral aneurysms, pulmonary, renal and cerebral arteriovenous malformations, patent ductus arteriosus, endoleaks). The main purpose of this trial is to evaluate the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with evidence of incomplete percutaneous/epicardial LAA exclusion.
- Conditions
- Left Atrial Appendage Incomplete Closure
- Being tested
- Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System, Azur Peripheral Coil System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interlock-35 Fibered IDC Occlusion SystemDevice
Use of detachable coil for LAA leak closure
Concerto Helix Detachable Coil SystemDevice
Use of detachable coil for LAA leak closure
Azur Peripheral Coil SystemDevice
Use of detachable coil for LAA leak closure
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | LAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System Receives: Device: Interlock-35 Fibered IDC Occlusion System; Device: Concerto Helix Detachable Coil System; Device: Azur Peripheral Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Procedural success, defined as successful delivery, deployment release of detachable coil(s) into the LAA, and incidence of LAA occlusion as measured by fluoroscopy and echocardiographic color Doppler jets less than 3mm by TEE at the end of the procedure.
Measured: 7 days
Rate of LAA leak closure
LAA occlusion will be assessed by TEE color Doppler and will be defined as absence of flow in the LAA or minimal color Doppler jets (< 1mm).
Measured: 60 days
Incidence of Major Adverse Events (MAE)
Rate of procedure- and device-related complications (device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; transient ischemic attack/stroke; systemic embolism; death; or any other event related to the device or the procedure, which requires treatment).
Measured: 30 days
Secondary outcomes (1)
Composite of all-cause mortality, stroke and bleeding
Composite: stroke or transient ischemic attack, systemic embolism, major bleeding event.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start9 Apr 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage Incomplete ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm study with consecutive, eligible subject enrollment. All subjects will undergo percutaneous LAA leak closure procedure with detachable coils.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503253
- Sponsor's protocol ID
- TCAI_Leak closure
- Acronym
- TREASURE
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No plan yet
Publications
Della Rocca DG, Horton RP, Di Biase L, Bassiouny M, Al-Ahmad A, Mohanty S, Gasperetti A, Natale VN, Trivedi C, Gianni C, Burkhardt JD, Gallinghouse GJ, Hranitzky P, Sanchez JE, Natale A. First Experience of Transcatheter Leak Occlusion With Detachable Coils Following Left Atrial Appendage Closure. JACC Cardiovasc Interv. 2020 Feb 10;13(3):306-319. doi: 10.1016/j.jcin.2019.10.022. Epub 2020 Jan 15.
PubMed 31954677
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
- ClinicalTrials.gov ID
- NCT03503253
- Acronym / sponsor ID
- TREASURE / TCAI_Leak closure
- Conditions
- Left Atrial Appendage Incomplete Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with detachable vascular coils.
Detailed description
Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-indications. Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete LAA closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. To date, detachable coils have found a wide range of applications for transcatheter occlusion/embolization procedures (e.g., cerebral aneurysms, pulmonary, renal and cerebral arteriovenous malformations, patent ductus arteriosus, endoleaks). The main purpose of this trial is to evaluate the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with evidence of incomplete percutaneous/epicardial LAA exclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm study with consecutive, eligible subject enrollment. All subjects will undergo percutaneous LAA leak closure procedure with detachable coils.
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Device: Interlock-35 Fibered IDC Occlusion System, Device: Concerto Helix Detachable Coil System, Device: Azur Peripheral Coil SystemLAA leak closure using detachable coils; Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age> 18 years.
- Presence of a significant LAA leak (moderate/severe following percutaneous occlusions or mild/severe after epicardial exclusions with the LARIAT suture delivery device).
- Less moderate embolic risk (CHA2DS2-VASc ≥2)
- High associated hemorrhagic risk (HASBLED ≥ 3), or absolute contraindication to OAC, or need for prolonged dual antiplatelet therapy, or history of thromboembolic events despite LAA occlusion/exclusion after other potential causes.
- written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Key exclusion criteria (3 listed)
- Life expectancy < 2 years.
- pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interlock-35 Fibered IDC Occlusion SystemUse of detachable coil for LAA leak closure | Device | Single-arm |
| Concerto Helix Detachable Coil SystemUse of detachable coil for LAA leak closure | Device | Single-arm |
| Azur Peripheral Coil SystemUse of detachable coil for LAA leak closure | Device | Single-arm |
Primary outcome
Procedural success
Time frame: 7 days
Procedural success, defined as successful delivery, deployment release of detachable coil(s) into the LAA, and incidence of LAA occlusion as measured by fluoroscopy and echocardiographic color Doppler jets less than 3mm by TEE at the end of the procedure.
Rate of LAA leak closure
Time frame: 60 days
LAA occlusion will be assessed by TEE color Doppler and will be defined as absence of flow in the LAA or minimal color Doppler jets (< 1mm).
Incidence of Major Adverse Events (MAE)
Time frame: 30 days
Rate of procedure- and device-related complications (device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; transient ischemic attack/stroke; systemic embolism; death; or any other event related to the device or the procedure, which requires treatment).
1 secondary outcome
Composite of all-cause mortality, stroke and bleeding
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 31954677Della Rocca DG, Horton RP, Di Biase L, Bassiouny M, Al-Ahmad A, Mohanty S, Gasperetti A, Natale VN, Trivedi C, Gianni C, Burkhardt JD, Gallinghouse GJ, Hranitzky P, Sanchez JE, Natale A. First Experience of Transcatheter Leak Occlusion With Detachable Coils Following Left Atrial Appendage Closure. JACC Cardiovasc Interv. 2020 Feb 10;13(3):306-319. doi: 10.1016/j.jcin.2019.10.022. Epub 2020 Jan 15.
- Individual participant dataSharing planned: Undecided. No plan yet
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale principal investigator
Texas Cardiac Arrhythmia Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interlock-35 Fibered IDC Occlusion System, Concerto Helix Detachable Coil System and Azur Peripheral Coil System in people with Left Atrial Appendage Incomplete Closure, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Natale (5127842651, andrea.natale@stdavids.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.