Stroke PreventionTHORACS-LAAONCT03838341
Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.
An observational study of Stroke Prevention and Atrial Fibrillation, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.
Trial summary
Polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Prevention, Atrial Fibrillation, Safety Issues
- What is being tested?
- AtriClip™ LAA Exclusion System and Oral anticoagulation therapy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 8 Jun 2015to 1 Jan 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: The registry will include all patients with atrial fibrillation with high risk of thromboembolic complications - CHA2DS2-VASc Score >2 and HASBLED score of => 2 refered to primary or secondary stroke prevention who do not require open chest surgery for other reasons.
Who may be able to join
- Age >18 years
- Lone atrial fibrillation
- Previous stroke or systemic thromboembolic complications
- High risk of thromboembolic complications assessed with CHA2DS2-VASc Score >2
- High bleeding risk assessed with HASBLED score => 2.
- Contraindications to oral anticoagulation
- Complications of the oral anticoagulation
- Acceptable surgical candidate, including use of general anaesthesia
Who cannot join
- Patient refusal
- Significant valve disease or coronary multi-vessel artery lesions requiring surgery
- Stroke/cerebrovascular accident (CVA) within previous 30 days
- Critical preoperative state
- Intra-Operative Exclusion Criteria
- Presence of thrombus in the left atrium or LAA as documented on intra-operative transesophageal echocardiography
- LAA tissue with significant adhesions (as evaluated by the surgeon) carries AtriClip placement overly risky.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
Warsaw, 02-507
Piotr Suwalski, PhD, +48225081269, suwalski.piotr@gmail.com
Anna Witkowska, MD, +48662076716, vera@rallywitkowscy.pl
About this study
Official title: Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.
Polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation.
Read the detailed description
The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive patients with atrial fibrillation assigned for the totally thoracoscopic left atrial appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The registry has no limit of the number of patient included. Patients will be followed up with transoesophageal echocardiography at 6-12 months to assess the durability of left atrial appendage (LAA) oclusion and collect the informations about possible adverse events.
- Conditions
- Stroke Prevention, Atrial Fibrillation, Safety Issues
- Being tested
- AtriClip™ LAA Exclusion System, Oral anticoagulation therapy
- Keywords
- Stroke prevention, Atrial fibrillation, Totally thoracoscopic, LAAO, AtriClip®
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriClip™ LAA Exclusion SystemDevice
Also called AtriClip LAA Exclusion System and Delivery System (LAAØ), AtriClip LAA Exclusion System and Delivery System (PRO1), AtriClip LAA Exclusion System and Delivery System (PRO2)
The left atrial appendage is closed from the epicardial side of the heart. Operative access is totally thoracoscopic. The designed and dedicated clip - AtriClip® (AtriCure, Ohio, USA) is introduced to the left pleura through thoracoscopic port.
Oral anticoagulation therapyDrug
Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.
| Study group | Role | What they receive |
|---|---|---|
| Included | The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention. Receives: Device: AtriClip™ LAA Exclusion System; Drug: Oral anticoagulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative complications
Number of perioperative complications associated with AtriClip placement
Measured: First 5 postoperative days
Intraoperative success of exclusion of LAA.
Successful exclusion of LAA is defined as no communication between LAA and LA and < 5 mm LAA remnant measured by intraoperative transesophageal echo with Doppler.
Measured: Intraoperatively
Secondary outcomes (3)
Major adverse cardiac and cerebrovascular events (MACCE)
Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke.
Measured: 5 years
Pulmonary complications.
Number of participants requiring prolonged mechanical ventilation postoperatively
Measured: Up to 30 days post operation
Any complications connected with surgical intervention
Rate of bleeding requiring transfusion or re-operation, phrenic nerve palsy, oedema requiring intervention, wound infection, abscess in pleura
Measured: Up to 30 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start8 Jun 2015
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PreventionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Suwalski, PhD, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
- Investigators
- Piotr Suwalski, PhD, Principal investigator, Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838341
- Sponsor's protocol ID
- ThR-LAAO-PL
- Acronym
- THORACS-LAAO
- Status last verified
- Mar 2019
- First submitted
- 27 Jan 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.
- ClinicalTrials.gov ID
- NCT03838341
- Acronym / sponsor ID
- THORACS-LAAO / ThR-LAAO-PL
- Conditions
- Stroke Prevention, Atrial Fibrillation, Safety Issues
- Keywords
- Stroke prevention, Atrial fibrillation, Totally thoracoscopic, LAAO, AtriClip®
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, PolandUniversity, hospital or other
- Study start
- 8 Jun 2015 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Feb 2019 (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.
Polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation.
Detailed description
The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive patients with atrial fibrillation assigned for the totally thoracoscopic left atrial appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The registry has no limit of the number of patient included. Patients will be followed up with transoesophageal echocardiography at 6-12 months to assess the durability of left atrial appendage (LAA) oclusion and collect the informations about possible adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included | – | Device: AtriClip™ LAA Exclusion System, Drug: Oral anticoagulation therapyThe consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will include all patients with atrial fibrillation with high risk of thromboembolic complications - CHA2DS2-VASc Score >2 and HASBLED score of => 2 refered to primary or secondary stroke prevention who do not require open chest surgery for other reasons.
Key inclusion criteria (8 listed)
- Age >18 years
- Lone atrial fibrillation
- Previous stroke or systemic thromboembolic complications
- High risk of thromboembolic complications assessed with CHA2DS2-VASc Score >2
- High bleeding risk assessed with HASBLED score => 2.
Key exclusion criteria (7 listed)
- Patient refusal
- Significant valve disease or coronary multi-vessel artery lesions requiring surgery
- Stroke/cerebrovascular accident (CVA) within previous 30 days
- Critical preoperative state
- Intra-Operative Exclusion Criteria
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 |
|---|---|---|
| AtriClip™ LAA Exclusion SystemAlso: AtriClip LAA Exclusion System and Delivery System (LAAØ), AtriClip LAA Exclusion System and Delivery System (PRO1), AtriClip LAA Exclusion System and Delivery System (PRO2)The left atrial appendage is closed from the epicardial side of the heart. Operative access is totally thoracoscopic. The designed and dedicated clip - AtriClip® (AtriCure, Ohio, USA) is introduced to the left pleura through thoracoscopic port. | Device | Included |
| Oral anticoagulation therapyAnticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator. | Drug | Included |
Primary outcome
Perioperative complications
Time frame: First 5 postoperative days
Number of perioperative complications associated with AtriClip placement
Intraoperative success of exclusion of LAA.
Time frame: Intraoperatively
Successful exclusion of LAA is defined as no communication between LAA and LA and < 5 mm LAA remnant measured by intraoperative transesophageal echo with Doppler.
3 secondary outcomes
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 5 years
Pulmonary complications.
Time frame: Up to 30 days post operation
Any complications connected with surgical intervention
Time frame: Up to 30 days post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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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.
Piotr Suwalski, PhD principal investigator
Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Prevention and Atrial Fibrillation, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.
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 8 inclusion and 7 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 5 Mar 2019. 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 Poland. 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 Piotr Suwalski, PhD (+48225081269, suwalski.piotr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative complications (time frame: First 5 postoperative days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2019.