Atrial FibrillationNCT05125159
Angioplasty Guidewire-Assisted Versus Conventional Transseptal Puncture for Left Atrial Appendage Occlusion
A study testing angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture in people with Atrial Fibrillation, run by RenJi Hospital at 1 site in China.
Trial summary
This will be a prospective, single-blinded, three-center, randomized, controlled trial comparing the effectiveness and safety of angioplasty guidewire-assisted transseptal puncture (GW-TSP) technique to transseptal left atrial (LA) access with conventional transseptal puncture with standard transseptal equipment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 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
- Patient is referred to receive a LAAO procedure for atrial fibrillation, requiring transseptal access and LA catheterization
- Patients greater than 18 years of age
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection
Who cannot join
- Previous left atrial (LA) ablation or LA surgery
- Active Intracardiac Thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Cardiac valve prosthesis
Show all 16Show fewer
- Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
- Cardiac surgery during the three-month interval preceding the consent date
- Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- Significant chronic kidney disease (CKD - eGFR <30 µMol/L)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
- Pregnancy
- Life expectancy less than one year
- Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
- Unwilling or unable to comply fully with study procedures and follow-up
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: Randomized Trial of Angioplasty Guidewire-Assisted Transseptal Puncture Technique Versus Conventional Technique for Left Atrial Access in Left Atrial Appendage Occlusion
This will be a prospective, single-blinded, three-center, randomized, controlled trial comparing the effectiveness and safety of angioplasty guidewire-assisted transseptal puncture (GW-TSP) technique to transseptal left atrial (LA) access with conventional transseptal puncture with standard transseptal equipment (CON-TSP) in patients undergoing left atrial appendage occlusion (LAAO) procedure for atrial fibrillation. The targeted population will consist of patients with atrial fibrillation undergoing LAAO.
Read the detailed description
Transseptal catheterization is a critical step for left atrial interventions (atrial fibrillation ablation, LA appendage closure, mitral valve interventions). The availability of suitable tools and techniques is essential to safely perform the TSP, effectively deliver radiofrequency lesions, deploy LA devices, and anticipate difficult procedural situations in which complications may arise. Historically, a conventional Brockenbrough (BRK) needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature. Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur.
This study is intended to assess the safety, performance and usability of the angioplasty guidewire in facilitating access to the left atrium during LAAO procedures for the treatment of atrial fibrillation (AF). Moreover, the study will assess the impact of the GW-TSP on procedural times, including time to achieve left atrial accesses, total procedure times, total fluoroscopy time. The study is a prospective, single-blinded, three-center, randomized, controlled trial. Enrolled subjects who meet the study inclusion/exclusion criteria will be evaluated during the LAAO procedures and followed until release from hospital post procedure per institutional standard of care. After 30 days, patient will be contacted by telephone to obtain information on their clinical condition and any adverse events; if necessary, a clinic visit may be performed when required by the physician.
- Conditions
- Atrial Fibrillation
- Being tested
- angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal punctureProcedure or surgery
Patients randomized to the angioplasty guidewire-assisted transseptal puncture (GW-TSP) group will undergo transseptal puncture with angioplasty guidewire-assistance.
Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical).
| Study group | Role | What they receive |
|---|---|---|
| angioplasty guidewire-assisted transseptal group | Experimental | Patients randomized to the angioplasty guidewire-assisted transseptal puncture (GW-TSP) group will undergo transseptal puncture with angioplasty guidewire-assistance. Receives: Procedure: angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture |
| Conventional transseptal group | Sham comparator | Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical). Receives: Procedure: angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total transseptal puncture time
in minutes and seconds. (Total time required for left atrial access)
Measured: Intraprocedural assessment (within 24 hours)
Secondary outcomes (8)
Time from sheath in superior vena cava to sheath in fossa ovalis
The time that sheath slides from superior vena cava to fossa ovalis
Measured: Intraprocedural assessment (measured in seconds)
Time from needle in fossa ovalis to needle in left atrial
The time of sheath needle advancement through the septum and into the left atrial.
Measured: Intraprocedural assessment (measured in seconds)
Time from needle in left atrial to sheath in left atrial
Time of needle advancement through the septum to sheath advancement into the left atrial.
Measured: Intraprocedural assessment (measured in seconds)
Time from sheath in left atrial to sheath in pulmonary vein
The time that sheath enters the pulmonary vein after advancement into the left atrial.
Measured: Intraprocedural assessment (measured in seconds)
Total fluoroscopy time
Total fluoroscopy time
Measured: in seconds
Total procedural time
Total procedural time
Measured: in minutes
contrast volume
contrast used in transseptal puncture
Measured: During or immediately after procedure
Procedure related complication rate
The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture; events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture
Measured: Acute peri-procedural complications will be defined as occurring within 30 days of LAAO: during or immediately after procedure, up to 1 day after procedure, up to 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Model description
- 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LY Gu, Study chair, Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji HospitalH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125159
- Sponsor's protocol ID
- AGILE-LA Study
- Status last verified
- Jan 2021
- First submitted
- 31 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu F, Xu B, Qiao Z, Cheng F, Zhou Z, Zou Z, Zang M, Ding S, Hong J, Xie Y, Zhou Y, Huang J, Pu J. Angioplasty Guidewire-Assisted vs. Conventional Transseptal Puncture for Left Atrial Appendage Occlusion: a multicentre randomized controlled trial. Europace. 2023 Dec 6;25(12):euad349. doi: 10.1093/europace/euad349.
PubMed 38011331
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Angioplasty Guidewire-Assisted Transseptal Puncture Technique Versus Conventional Technique for Left Atrial Access in Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT05125159
- Acronym / sponsor ID
- AGILE-LA Study
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 18 Nov 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.
This will be a prospective, single-blinded, three-center, randomized, controlled trial comparing the effectiveness and safety of angioplasty guidewire-assisted transseptal puncture (GW-TSP) technique to transseptal left atrial (LA) access with conventional transseptal puncture with standard transseptal equipment (CON-TSP) in patients undergoing left atrial appendage occlusion (LAAO) procedure for atrial fibrillation. The targeted population will consist of patients with atrial fibrillation undergoing LAAO.
Detailed description
Transseptal catheterization is a critical step for left atrial interventions (atrial fibrillation ablation, LA appendage closure, mitral valve interventions). The availability of suitable tools and techniques is essential to safely perform the TSP, effectively deliver radiofrequency lesions, deploy LA devices, and anticipate difficult procedural situations in which complications may arise. Historically, a conventional Brockenbrough (BRK) needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature. Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur.
This study is intended to assess the safety, performance and usability of the angioplasty guidewire in facilitating access to the left atrium during LAAO procedures for the treatment of atrial fibrillation (AF). Moreover, the study will assess the impact of the GW-TSP on procedural times, including time to achieve left atrial accesses, total procedure times, total fluoroscopy time. The study is a prospective, single-blinded, three-center, randomized, controlled trial. Enrolled subjects who meet the study inclusion/exclusion criteria will be evaluated during the LAAO procedures and followed until release from hospital post procedure per institutional standard of care. After 30 days, patient will be contacted by telephone to obtain information on their clinical condition and any adverse events; if necessary, a clinic visit may be performed when required by the physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
| Arm | Type | Receives |
|---|---|---|
| angioplasty guidewire-assisted transseptal group | Experimental | Procedure: angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncturePatients randomized to the angioplasty guidewire-assisted transseptal puncture (GW-TSP) group will undergo transseptal puncture with angioplasty guidewire-assistance. |
| Conventional transseptal group | Sham comparator | Procedure: angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncturePatients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is referred to receive a LAAO procedure for atrial fibrillation, requiring transseptal access and LA catheterization
- Patients greater than 18 years of age
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection
Key exclusion criteria (16 listed)
- Previous left atrial (LA) ablation or LA surgery
- Active Intracardiac Thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
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 |
|---|---|---|
| angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncturePatients randomized to the angioplasty guidewire-assisted transseptal puncture (GW-TSP) group will undergo transseptal puncture with angioplasty guidewire-assistance. Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with BRK needle (St. Jude Medical). | Procedure or surgery | Conventional transseptal group, angioplasty guidewire-assisted transseptal group |
Primary outcome
Total transseptal puncture time
Time frame: Intraprocedural assessment (within 24 hours)
in minutes and seconds. (Total time required for left atrial access)
8 secondary outcomes
Time from sheath in superior vena cava to sheath in fossa ovalis
Time frame: Intraprocedural assessment (measured in seconds)
Time from needle in fossa ovalis to needle in left atrial
Time frame: Intraprocedural assessment (measured in seconds)
Time from needle in left atrial to sheath in left atrial
Time frame: Intraprocedural assessment (measured in seconds)
Time from sheath in left atrial to sheath in pulmonary vein
Time frame: Intraprocedural assessment (measured in seconds)
Total fluoroscopy time
Time frame: in seconds
Total procedural time
Time frame: in minutes
contrast volume
Time frame: During or immediately after procedure
Procedure related complication rate
Time frame: Acute peri-procedural complications will be defined as occurring within 30 days of LAAO: during or immediately after procedure, up to 1 day after procedure, up to 30 days after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Derived from this study: PubMed 38011331Hu F, Xu B, Qiao Z, Cheng F, Zhou Z, Zou Z, Zang M, Ding S, Hong J, Xie Y, Zhou Y, Huang J, Pu J. Angioplasty Guidewire-Assisted vs. Conventional Transseptal Puncture for Left Atrial Appendage Occlusion: a multicentre randomized controlled trial. Europace. 2023 Dec 6;25(12):euad349. doi: 10.1093/europace/euad349.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
LY Gu study chair
Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji HospitalH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angioplasty guidewire-assisted transseptal puncture or Standard conventional transseptal puncture in people with Atrial Fibrillation, 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 3 inclusion and 16 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 18 Nov 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 (13817577592, Pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total transseptal puncture time (time frame: Intraprocedural assessment (within 24 hours)). 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 NCT05125159, 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 18 Nov 2021.