Non-valvular Atrial FibrillationNCT04193826
The Conformal Prague Study
A study testing Left Atrial Appendage Closure in people with Non-valvular Atrial Fibrillation, run by Conformal Medical, Inc at 1 site in Czechia.
Trial summary
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- Left Atrial Appendage Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 19 Oct 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female aged ≥18 years
- Documented non-valvular AF (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2
- The patient is recommended for oral anticoagulation therapy (OAC), but has an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
- The patient is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations
- The patient (or legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Ethics Committee (EC)
Who cannot join
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
- Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or patent foramen ovale [PFO], surgical repair or implanted closure device, or obliterated or ligated left atrial appendage)
- Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Patients with a medical condition (other than atrial fibrillation) that mandates chronic oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
- Active infection with bacteremia
Show all 20Show fewer
- Documented symptomatic carotid artery disease (>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of >70%)
- Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure
- Recent (within 90 days of index procedure) stroke, transient ischemic attack
- Recent myocardial infarction within 60 days of index procedure
- Vascular access precluding delivery of implant with catheter-based system
- Severe heart failure (New York Heart Association Class III or IV)
- Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation), or dialysis at the time of screening
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3
- Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, or device materials (e.g., nickel, titanium, gold), or the patient has contrast sensitivity that cannot be adequately pre-medicated
- Current participation in another investigational drug or device study that interferes with this study
- Patient is a prisoner
- Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 1 year
- Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Conformal Prague Study: An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.
Read the detailed description
The primary objective of the study is to evaluate feasibility of ICE as primary imaging modality for device success in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism who are recommended for oral anticoagulation (OAC) therapy but have an appropriate rationale to seek a non-pharmacological alternative to OAC. TEE will be used to confirm the ICE evaluation.
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- Left Atrial Appendage Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage ClosureDevice
Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing
| Study group | Role | What they receive |
|---|---|---|
| Non-valvular AF adults | Experimental | Left atrial appendage closure (LAAC) with the Conformal LAAC device will be performed according to the device Instructions for Use, based on ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing. Receives: Device: Left Atrial Appendage Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Major Adverse Events
Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.
Measured: 7 days post-procedure
Closure Success
Closure success, defined as device success followed by complete closure or peri-device residual leak ≤5 mm in width
Measured: 45-days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start19 Oct 2019
- Primary completion30 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial FibrillationStudies 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
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conformal Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193826
- Sponsor's protocol ID
- 19-101
- Status last verified
- Aug 2024
- First submitted
- 6 Dec 2019
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Turagam MK, Neuzil P, Hala P, Mraz T, Dukkipati SR, Reddy VY. Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes. JACC Clin Electrophysiol. 2022 Feb;8(2):197-207. doi: 10.1016/j.jacep.2021.10.001. Epub 2021 Nov 24.
PubMed 35210077
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Conformal Prague Study: An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT04193826
- Acronym / sponsor ID
- 19-101
- Conditions
- Non-valvular Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Conformal Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.
Detailed description
The primary objective of the study is to evaluate feasibility of ICE as primary imaging modality for device success in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism who are recommended for oral anticoagulation (OAC) therapy but have an appropriate rationale to seek a non-pharmacological alternative to OAC. TEE will be used to confirm the ICE evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Non-valvular AF adults | Experimental | Device: Left Atrial Appendage ClosureLeft atrial appendage closure (LAAC) with the Conformal LAAC device will be performed according to the device Instructions for Use, based on ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant female aged ≥18 years
- Documented non-valvular AF (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2
- The patient is recommended for oral anticoagulation therapy (OAC), but has an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
- The patient is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations
Key exclusion criteria (20 listed)
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
- Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or patent foramen ovale [PFO], surgical repair or implanted closure device, or obliterated or ligated left atrial appendage)
- Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Patients with a medical condition (other than atrial fibrillation) that mandates chronic oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
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 |
|---|---|---|
| Left Atrial Appendage ClosureClosure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing | Device | Non-valvular AF adults |
Primary outcome
Freedom From Major Adverse Events
Time frame: 7 days post-procedure
Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.
Closure Success
Time frame: 45-days post-procedure
Closure success, defined as device success followed by complete closure or peri-device residual leak ≤5 mm in width
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35210077Turagam MK, Neuzil P, Hala P, Mraz T, Dukkipati SR, Reddy VY. Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes. JACC Clin Electrophysiol. 2022 Feb;8(2):197-207. doi: 10.1016/j.jacep.2021.10.001. Epub 2021 Nov 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Appendage Closure in people with Non-valvular Atrial Fibrillation, run by Conformal Medical, Inc at 1 site in Czechia.
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 6 inclusion and 20 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: finished, as of the sponsor's last update on 24 Sep 2024. 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 Czechia. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Major Adverse Events (time frame: 7 days post-procedure). 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?
On the ClinicalTrials.gov record for NCT04193826, 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 24 Sep 2024.