CardiologyNCT04913207
Comprehensive CT-guided vs Echo-fluoroscopy-guided Strategy in the Left Atrial Appendage Occlusion
A study testing method of device size selection in people with Cardiology, run by RenJi Hospital at 1 site in China.
Trial summary
Percutaneous left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (AF). Transesophageal echocardiography (TEE) and fluoroscopy were used to measure the maximal diameters of LAA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiology
- What is being tested?
- method of device size selection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Dec 2023
- 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
- Clinical diagnosis of atrial fibrillation Disease
- Age >18years
- CHA2DS2-VASc scores ≥ 2
- And at least one of the following indications: (a) HAS- BLED scores ≥ 3; (b) intolerance to long-term OAC; (c) stroke, TIA or thromboembolism even under OAC treatment
Who cannot join
- GFR <50 mL/min/1.73 m2
- Thrombus in LA and LAA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
Shanghai, Shanghai Municipality, 200127
JUN PU, Doctor, +86 13817577592, pujun310@hotmail.com
About this study
Official title: Comparison of Comprehensive CT-guided Versus Traditonal Echo-fluoroscopy-guided Strategy in the Implantation of the LAmbre Left Atrial Appendage Occlusion, a Prospective, Multi-center and Randomized Trial
Percutaneous left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (AF). Transesophageal echocardiography (TEE) and fluoroscopy were used to measure the maximal diameters of LAA. However, the LAA maximal diameters measured on Two dimensional (2D) views could be limited due to the morphology of LAA varies with each individua. Three dimension computed tomography angiography technology (3D-CTA) is based on cardiac computed tomography angiography (CCTA). The 3D-CTA technology provides an innovative measuring method of LAA to guide the selection of device size, and the best fluoroscopy view to implant device. This measuring method and guideline have never been reported and its role in LAAO is uncertain
Read the detailed description
The PERIVISION-LAAO study will be a prospective, multi-center and randomized trial designed to investigate the effect and safety of perimeter obtained by 3D-CTA versus diameter obtained by traditional echo-fluoroscopy in guidance of device size selection in the procedure of LAAO. It will enroll 310 patients with nonvalvular atrial fibrillation (AF) who will be randomized at 1:1 ratio into the perimeter guidance group or diameter guidance group. The major effect endpoint will be the success at first device selected in procedure, and the major safety outcome will be the incidence of pericardial effusion during the procedure and the follow-up period of 2 months after the procedure.
- Conditions
- Cardiology
- Being tested
- method of device size selection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
method of device size selectionProcedure or surgery
device size selection based on 3D-CTA
| Study group | Role | What they receive |
|---|---|---|
| Traditional echo-fluoroscopy guided group | Sham comparator | LAA angiography is performed with a 6F pigtail catheter in LAA at the view of RAO 30°, CAU 20° and RAO 30°, CRA 20°. Next, the outline of the LAA will be drawn on the screen according to the LAA angiography. LAmbre device size selection is based on diameters of LAA ostium and landing zone measured on LAA angiography. The process of device implantation, assessment, releasing will be carried out at RAO 30°, CAU 20°. TEE is used to check whether the residual peri-device leaks is less than 5mm. The device will be released if it passes the 'COST' standard; otherwise readjusting the implantation position, change the device size and even re-puncturing transseptal to achieve a better axis will be proceeded. Receives: Procedure: method of device size selection |
| 3D-CTA guided group | Experimental | Patients in 3D-CTA based perimeter group will undergo CCTA examination before LAAO and a 3D model of the left atrium is reconstructed by a workstation. LAmbre device size selection is based on perimeters of LAA ostium and landing zone which are obtained by the measurement method shown previously in this protocol. After transseptal puncture, LAA angiography is performed with a 6F pigtail catheter in LAA at the tangent angle view which is obtained preoperatively by 3D-CCTA. Then, the outline of the LAA will be drawn on the screen according to the LAA angiography. The process of device implantation, assessment, releasing will be carried out at this tangent angle view. TEE is used to check whether the residual peri-device leaks is less than 5mm. The device will be released if it passes the 'COST' standard; otherwise readjusting the implantation position, change the device size and even re-puncturing transseptal to achieve a better axis will be proceeded. Receives: Procedure: method of device size selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of success at first device selected
the device selected successfully at first time during LAAO
Measured: In the procedure of LAAO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiologyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HJ LUO, Study chair, Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913207
- Sponsor's protocol ID
- LAAO-3DCT
- Status last verified
- Mar 2021
- First submitted
- 27 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Comprehensive CT-guided Versus Traditonal Echo-fluoroscopy-guided Strategy in the Implantation of the LAmbre Left Atrial Appendage Occlusion, a Prospective, Multi-center and Randomized Trial
- ClinicalTrials.gov ID
- NCT04913207
- Acronym / sponsor ID
- LAAO-3DCT
- Conditions
- Cardiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Jun 2021 (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.
Percutaneous left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (AF). Transesophageal echocardiography (TEE) and fluoroscopy were used to measure the maximal diameters of LAA. However, the LAA maximal diameters measured on Two dimensional (2D) views could be limited due to the morphology of LAA varies with each individua. Three dimension computed tomography angiography technology (3D-CTA) is based on cardiac computed tomography angiography (CCTA). The 3D-CTA technology provides an innovative measuring method of LAA to guide the selection of device size, and the best fluoroscopy view to implant device. This measuring method and guideline have never been reported and its role in LAAO is uncertain
Detailed description
The PERIVISION-LAAO study will be a prospective, multi-center and randomized trial designed to investigate the effect and safety of perimeter obtained by 3D-CTA versus diameter obtained by traditional echo-fluoroscopy in guidance of device size selection in the procedure of LAAO. It will enroll 310 patients with nonvalvular atrial fibrillation (AF) who will be randomized at 1:1 ratio into the perimeter guidance group or diameter guidance group. The major effect endpoint will be the success at first device selected in procedure, and the major safety outcome will be the incidence of pericardial effusion during the procedure and the follow-up period of 2 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional echo-fluoroscopy guided group | Sham comparator | Procedure: method of device size selectionLAA angiography is performed with a 6F pigtail catheter in LAA at the view of RAO 30°, CAU 20° and RAO 30°, CRA 20°. Next, the outline of the LAA will be drawn on the screen according to the LAA angiography. LAmbre device size selection is based on diameters of LAA ostium and landing zone measured on LAA angiography. The process of device implantation, assessment, releasing will be carried out at RAO 30°, CAU 20°. TEE is used to check whether the residual peri-device leaks is less than 5mm. The device will be released if it passes the 'COST' standard; otherwise readjusting the implantation position, change the device size and even re-puncturing transseptal to achieve a better axis will be proceeded. |
| 3D-CTA guided group | Experimental | Procedure: method of device size selectionPatients in 3D-CTA based perimeter group will undergo CCTA examination before LAAO and a 3D model of the left atrium is reconstructed by a workstation. LAmbre device size selection is based on perimeters of LAA ostium and landing zone which are obtained by the measurement method shown previously in this protocol. After transseptal puncture, LAA angiography is performed with a 6F pigtail catheter in LAA at the tangent angle view which is obtained preoperatively by 3D-CCTA. Then, the outline of the LAA will be drawn on the screen according to the LAA angiography. The process of device implantation, assessment, releasing will be carried out at this tangent angle view. TEE is used to check whether the residual peri-device leaks is less than 5mm. The device will be released if it passes the 'COST' standard; otherwise readjusting the implantation position, change the device size and even re-puncturing transseptal to achieve a better axis will be proceeded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of atrial fibrillation Disease
- Age >18years
- CHA2DS2-VASc scores ≥ 2
- And at least one of the following indications: (a) HAS- BLED scores ≥ 3; (b) intolerance to long-term OAC; (c) stroke, TIA or thromboembolism even under OAC treatment
Key exclusion criteria (2 listed)
- GFR <50 mL/min/1.73 m2
- Thrombus in LA and LAA
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 |
|---|---|---|
| method of device size selectiondevice size selection based on 3D-CTA | Procedure or surgery | 3D-CTA guided group, Traditional echo-fluoroscopy guided group |
Primary outcome
the rate of success at first device selected
Time frame: In the procedure of LAAO
the device selected successfully at first time during LAAO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- 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.
HJ LUO study chair
Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing method of device size selection in people with Cardiology, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 2 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 4 Jun 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 China. 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. Some participants in this study may receive a placebo. 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 JUN PU, Doctor (+86 13817577592, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of success at first device selected (time frame: In the procedure of LAAO). 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 4 Jun 2021.