Atrial FibrillationNCT05106270
The Impact of Atrial Pressure Change Before and After Combined Procedure
An observational study of Atrial Fibrillation and Heart Failure, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Atrial pressure measurement using transseptal puncture sheath
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2021to 10 Nov 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 study is designed to investigate the change of atrial pressure before and after combined procedure of catheter ablation and left atrial appendage closure, and evaluate its influence on prognosis. This study aims to recruit patients diagnosed with atrial fibrillation who are eligible for combined procedure. Patients with paroxysmal, persistent, or longstanding persistent AF are included, whether it is new-onset or drug refractory.
Who may be able to join
- Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months;
- Eligible for left atrial appendage closure, that meet at least one of the followings:
- At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
- Contraindicated to oral anticoagulation (OAC);
- Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment.
- Capable of understanding and signing the informed consent form.
- Aged over 18 years.
Who cannot join
- Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication;
- Concomitant arrhythmia including atrial flutter, ventricular tachycardia;
- A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation;
- A previous history of cardiac surgery including any valvular replacement, septal repair;
- A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation;
- A history of congenital heart disease;
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- A previous history of atrioventricular node ablation;
- A history of lobectomy due to any medical condition;
- Complicated by other diseases with life expectation <1 year;
- Women with childbearing potential;
- Participated in other interventional clinical trials that might affect prognosis;
- Unable to understand or give informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Zhongyuan Ren, MD, +8618862186450, cloudyrzy@gmail.com
Dongdong Zhao, MD, PhD, 249620601@163.com
About this study
Official title: The Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation
One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Although it could achieve considerable rhythm control and stroke prophylaxis, a number of patients has experienced progressive heart failure after the procedure. Notably, previous studies indicate that both pulmonary vein isolation by CA and LAAC could significantly increase left atrial pressure, while currently no study has investigated left atrial pressure change in patients underwent combined procedure. The investigators hypothesise that combined procedure would significantly increase left atrial pressure and subsequently deteriorate cardiac function. Therefore, the investigators aim to measure the left and right atrial pressure change before and after CA and LAAC in combined procedure, and investigate the influence of the pressure change on clinical outcomes.
Read the detailed description
- Study aim. This study was designed to measure the left and right atrial pressure change before and after catheter ablation (CA) and left atrial appendage closure (LAAC) combining procedure, and investigate the influence of the pressure change on clinical outcomes.
- Subject selection. This study is designed to recruit patients diagnosed with atrial fibrillation and planned to undergo combined procedure. Primary inclusion criteria are:
- Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; ii. Eligible for left atrial appendage closure, that meet at least one of the followings:
- At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
- Contraindicated to oral anticoagulation (OAC);
- Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment.
- Procedure detail. All the patients recruited is planned to undergo combined procedure. CA is performed before LAAC. For CA, the energy source is optional (either radiofrequency or cryoenergy). And ablation should be performed for pulmonary vein isolation only. For LAAC, the occluder type is optional (either plug or pacifier occluder), and intracardiac echocardiography or transesophageal echocardiography (TEE) is optional. For atrial pressure measurement, right atrial pressure should be measured before transseptal puncture and after combined procedure is accomplished. Left atrial pressure should be measured at 3 timepoints: after transseptal puncture, after pulmonary vein isolation and after LAAC. Atrial pressure is measured via Swartz transseptal puncture sheath. And at each timepoint, atrial pressure should be recorded at 1min, 3min, and 5min after the placement of the sheath.
- Follow-up. study endpoint includes a primary composite endpoint of rehospitalization due to heart failure and death due to cardiovascular disease, and secondary endpoints including: 1. all-cause mortality 2. major cardiovascular adverse event 3. rehospitalization due to cardiovascular diseases 4. recurrence of atrial arrhythmia 5. stoke/transient ischemic attack 6. echocardiographic measurement 7. quality of life evaluation 8. cardiac function evaluation 9. evaluation of left atrial appendage closure. Patients are required to have outpatient follow-up at 3rd month, 12th month, and every year since then. The anti-thromboembolic regimen should follow: 3-month OAC treatment and 3-month double anti-platelet therapy and lifelong single anti-platelet therapy. For LAAC follow-up, either TEE or CTA is scheduled to perform in the 3rd month after procedure.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Atrial pressure measurement using transseptal puncture sheath
- Keywords
- Left atrial pressure, combined procedure, Catheter ablation, Left atrial appendage closure, Cardiac function
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial pressure measurement using transseptal puncture sheathDiagnostic test
both left and right atrial pressure was measured using transseptal puncture sheath before and after combined procedure
| Study group | Role | What they receive |
|---|---|---|
| Combined procedure | The whole cohort underwent combining procedure of catheter ablation and left atrial appendage closure, atrial pressure was measured before and after pulmonary vein isolation, and after left atrial appendage closure. Receives: Diagnostic Test: Atrial pressure measurement using transseptal puncture sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
Rehospitalization due to heart failure and death due to cardiovascular disease
Measured: From date of inclusion until the date of first documented rehospitalization due to heart failure or date of death due to cardiovascular disease, whichever came first, assessed up to 60 months
Secondary outcomes (16)
All-cause mortality
death of any reason
Measured: From date of inclusion until the date of documented death of any reason, assessed up to 60 months
Major cardiovascular adverse event
cardiovascular events including myocardial infarction, malignant arrhythmia, acute heart failure, cardiac tamponade.
Measured: From date of inclusion until the date of first documented cardiovascular events mentioned above, assessed up to 60 months
Rehospitalization due to cardiovascular diseases
Rehospitalization due to any cardiovascular diseases
Measured: From date of inclusion until the date of first documented rehospitalization due to cardiovascular diseases, assessed up to 60 months
Early recurrence of atrial arrhythmia
Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter
Measured: From time of completion of combined procedure until the third month since the procedure
Recurrence of atrial arrhythmia
Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter
Measured: From the third month since the procedure until the date of recurrence of atrial arrhythmia as described above, assessed up to 60 months
Stoke/transient ischemic attack
Cerebral infarction, intracranial hemorrhage, or transient ischemic attack confirmed by CT/MRI
Measured: From date of inclusion until the date of first documented stoke/transient ischemic attack, assessed up to 60 months
Change from baseline echocardiographic measurement at 3 months
Echocardiographic measured left atrial parameters including left atrial volume, left atrial volume index, e, e' and left ventricle parameters including left ventricular ejection fraction, left ventricle systolic and diastolic diameter.
Measured: 3 months after combined procedure
Change from baseline echocardiographic measurement at 1 year
Echocardiographic measured left atrial parameters including left atrial volume, left atrial volume index, e, e' and left ventricle parameters including left ventricular ejection fraction, left ventricle systolic and diastolic diameter.
Measured: 1 year after combined procedure
Change from baseline echocardiographic measurement at 5 years
Echocardiographic measured left atrial parameters including left atrial volume, left atrial volume index, e, e' and left ventricle parameters including left ventricular ejection fraction, left ventricle systolic and diastolic diameter.
Measured: 5 years after combined procedure
Change from baseline quality of life evaluation at 3 months
EQ-5D questionnaire evaluation of quality of life
Measured: 3 months after combined procedure
Change from baseline quality of life evaluation at 1 year
EQ-5D questionnaire evaluation of quality of life
Measured: 1 year after combined procedure
Change from baseline quality of life evaluation at 5 years
EQ-5D questionnaire evaluation of quality of life
Measured: 5 years after combined procedure
Change from baseline walking distance of 6-min walk test at 3 months
Maximum walking distance measured from 6-min walk test
Measured: 3 months after combined procedure
Change from baseline walking distance of 6-min walk test at 1 year
Maximum walking distance measured from 6-min walk test
Measured: 1 year after combined procedure
Change from baseline walking distance of 6-min walk test at 5 years
Maximum walking distance measured from 6-min walk test
Measured: 5 years after combined procedure
Evaluation of left atrial appendage closure at 3 months
Either transesophageal echocardiography or CTA evaluation of occluder position, residual flow, presence of thrombosis.
Measured: 3 months after combined procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start10 Nov 2021
- Primary completion10 Nov 2023 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106270
- Sponsor's protocol ID
- APPREANCE-AF
- Status last verified
- Aug 2022
- First submitted
- 20 Sep 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05106270
- Acronym / sponsor ID
- APPREANCE-AF
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- Left atrial pressure, combined procedure, Catheter ablation, Left atrial appendage closure, Cardiac function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 3 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.
One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Although it could achieve considerable rhythm control and stroke prophylaxis, a number of patients has experienced progressive heart failure after the procedure. Notably, previous studies indicate that both pulmonary vein isolation by CA and LAAC could significantly increase left atrial pressure, while currently no study has investigated left atrial pressure change in patients underwent combined procedure. The investigators hypothesise that combined procedure would significantly increase left atrial pressure and subsequently deteriorate cardiac function. Therefore, the investigators aim to measure the left and right atrial pressure change before and after CA and LAAC in combined procedure, and investigate the influence of the pressure change on clinical outcomes.
Detailed description
- Study aim. This study was designed to measure the left and right atrial pressure change before and after catheter ablation (CA) and left atrial appendage closure (LAAC) combining procedure, and investigate the influence of the pressure change on clinical outcomes.
- Subject selection. This study is designed to recruit patients diagnosed with atrial fibrillation and planned to undergo combined procedure. Primary inclusion criteria are:
- Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; ii. Eligible for left atrial appendage closure, that meet at least one of the followings:
- At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
- Contraindicated to oral anticoagulation (OAC);
- Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment.
- Procedure detail. All the patients recruited is planned to undergo combined procedure. CA is performed before LAAC. For CA, the energy source is optional (either radiofrequency or cryoenergy). And ablation should be performed for pulmonary vein isolation only. For LAAC, the occluder type is optional (either plug or pacifier occluder), and intracardiac echocardiography or transesophageal echocardiography (TEE) is optional. For atrial pressure measurement, right atrial pressure should be measured before transseptal puncture and after combined procedure is accomplished. Left atrial pressure should be measured at 3 timepoints: after transseptal puncture, after pulmonary vein isolation and after LAAC. Atrial pressure is measured via Swartz transseptal puncture sheath. And at each timepoint, atrial pressure should be recorded at 1min, 3min, and 5min after the placement of the sheath.
- Follow-up. study endpoint includes a primary composite endpoint of rehospitalization due to heart failure and death due to cardiovascular disease, and secondary endpoints including: 1. all-cause mortality 2. major cardiovascular adverse event 3. rehospitalization due to cardiovascular diseases 4. recurrence of atrial arrhythmia 5. stoke/transient ischemic attack 6. echocardiographic measurement 7. quality of life evaluation 8. cardiac function evaluation 9. evaluation of left atrial appendage closure. Patients are required to have outpatient follow-up at 3rd month, 12th month, and every year since then. The anti-thromboembolic regimen should follow: 3-month OAC treatment and 3-month double anti-platelet therapy and lifelong single anti-platelet therapy. For LAAC follow-up, either TEE or CTA is scheduled to perform in the 3rd month after procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined procedure | – | Diagnostic Test: Atrial pressure measurement using transseptal puncture sheathThe whole cohort underwent combining procedure of catheter ablation and left atrial appendage closure, atrial pressure was measured before and after pulmonary vein isolation, and after left atrial appendage closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is designed to investigate the change of atrial pressure before and after combined procedure of catheter ablation and left atrial appendage closure, and evaluate its influence on prognosis. This study aims to recruit patients diagnosed with atrial fibrillation who are eligible for combined procedure. Patients with paroxysmal, persistent, or longstanding persistent AF are included, whether it is new-onset or drug refractory.
Key inclusion criteria (7 listed)
- Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months;
- Eligible for left atrial appendage closure, that meet at least one of the followings:
- Capable of understanding and signing the informed consent form.
- Aged over 18 years.
Key exclusion criteria (12 listed)
- Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication;
- Concomitant arrhythmia including atrial flutter, ventricular tachycardia;
- A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation;
- A previous history of cardiac surgery including any valvular replacement, septal repair;
- A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation;
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 |
|---|---|---|
| Atrial pressure measurement using transseptal puncture sheathboth left and right atrial pressure was measured using transseptal puncture sheath before and after combined procedure | Diagnostic test | Combined procedure |
Primary outcome
Composite endpoint
Time frame: From date of inclusion until the date of first documented rehospitalization due to heart failure or date of death due to cardiovascular disease, whichever came first, assessed up to 60 months
Rehospitalization due to heart failure and death due to cardiovascular disease
16 secondary outcomes
All-cause mortality
Time frame: From date of inclusion until the date of documented death of any reason, assessed up to 60 months
Major cardiovascular adverse event
Time frame: From date of inclusion until the date of first documented cardiovascular events mentioned above, assessed up to 60 months
Rehospitalization due to cardiovascular diseases
Time frame: From date of inclusion until the date of first documented rehospitalization due to cardiovascular diseases, assessed up to 60 months
Early recurrence of atrial arrhythmia
Time frame: From time of completion of combined procedure until the third month since the procedure
Recurrence of atrial arrhythmia
Time frame: From the third month since the procedure until the date of recurrence of atrial arrhythmia as described above, assessed up to 60 months
Stoke/transient ischemic attack
Time frame: From date of inclusion until the date of first documented stoke/transient ischemic attack, assessed up to 60 months
Change from baseline echocardiographic measurement at 3 months
Time frame: 3 months after combined procedure
Change from baseline echocardiographic measurement at 1 year
Time frame: 1 year after combined procedure
Change from baseline echocardiographic measurement at 5 years
Time frame: 5 years after combined procedure
Change from baseline quality of life evaluation at 3 months
Time frame: 3 months after combined procedure
Change from baseline quality of life evaluation at 1 year
Time frame: 1 year after combined procedure
Change from baseline quality of life evaluation at 5 years
Time frame: 5 years after combined procedure
Change from baseline walking distance of 6-min walk test at 3 months
Time frame: 3 months after combined procedure
Change from baseline walking distance of 6-min walk test at 1 year
Time frame: 1 year after combined procedure
Change from baseline walking distance of 6-min walk test at 5 years
Time frame: 5 years after combined procedure
Evaluation of left atrial appendage closure at 3 months
Time frame: 3 months after combined procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Yawei Xu principal investigator
Shanghai 10th People's Hospital
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 Atrial Fibrillation and Heart Failure, run by Shanghai 10th People's 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 Sep 2022. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongdong Zhao (+86 18917684008, zhaodd@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (time frame: From date of inclusion until the date of first documented rehospitalization due to heart failure or date of death due to cardiovascular disease, whichever came first, assessed up to 60 months). 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 2 Sep 2022.