Atrial FibrillationNCT02929836
Catheter Ablation of Longstanding Persistent Atrial Fibrillation
A study testing PVI, LA linear ablation and CFAE ablation in people with Atrial Fibrillation, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVI, LA linear ablation and CFAE ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Oct 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with longstanding persistent atrial fibrillation (lasting for>1 year)
- Exhibited refractoriness to at least one antiarrhythmic drug
- Left atrial diameter <=60mm
Who cannot join
- Patients with uncontrolled congestive heart failure
- Having significant valvular disease and/or prosthetic heart valve(s)
- With myocardial infarction or stroke within 6 months of screening
- With Significant congenital heart disease;ejection fraction was <40% measured by echocardiography
- Allergic to contrast media
- Contraindication to warfarin or heparin
Show all 12Show fewer
- Severe pulmonary disease e.g. restrictive pulmonary disease
- Chronic obstructive disease (COPD)
- Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography
- Having any contraindication to right or left sided heart catheterization
- Poor general health
- Life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai chest hospital
Shanghai, Shanghai Municipality, 200030
Xu Liu, MD, 08613017321303, xkliuxuchest@163.com
About this study
Official title: Optimal Ablation Endpoint for Longstanding Persistent Atrial Fibrillation: a Randomized Prospective Study
This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.
Read the detailed description
Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- PVI, LA linear ablation, CFAE ablation, linear ablation, CARTO
- Keywords
- Ablation Linear Lesions
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIProcedure or surgery
PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.
LA linear ablationProcedure or surgery
LA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs).
CFAE ablationProcedure or surgery
Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.
linear ablationProcedure or surgery
Right atrial CTI ablation was performed during SR.
CARTODevice
3 dimensional mapping system
| Study group | Role | What they receive |
|---|---|---|
| PVI+LA linear ablation +CFAE ablation | Active comparator | The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation. Receives: Procedure: PVI; Procedure: LA linear ablation; Procedure: CFAE ablation; Device: CARTO |
| PVI+linear ablation +CFAE ablation | Active comparator | The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation. Receives: Procedure: PVI; Procedure: LA linear ablation; Procedure: CFAE ablation; Procedure: linear ablation; Device: CARTO |
| PVI+CFAE ablation | Active comparator | The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation. Receives: Procedure: PVI; Procedure: CFAE ablation; Device: CARTO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first documented recurrence of atrial arrhythmias
Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure
Measured: 2-year follow-up
Secondary outcomes (6)
Procedure duration at ablation
Minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter
Measured: At the end of the first ablation procedure
Ablation time at ablation
Minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery
Measured: At the end of the first ablation procedure ]
Fluoroscopy time at ablation
Minutes of fluoroscopy used during the entire ablation procedure
Measured: At the end of the first ablation procedure
Complications
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.
Measured: 2-year follow-up
Type of recurrent arrhythmia
Specific type of recurrent atrial arrhythmia
Measured: 2-year follow-up
Number of redo procedures
Number of redo procedures，including two or more procedures
Measured: 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionOct 2018 (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.
- More trials run by Shanghai Chest 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang yuanlong, Shanghai Chest Hospital
- Investigators
- Xu Mr Liu, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929836
- Sponsor's protocol ID
- DSL-20161002
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Ablation Endpoint for Longstanding Persistent Atrial Fibrillation: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02929836
- Acronym / sponsor ID
- DSL-20161002
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation Linear Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- 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 randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.
Detailed description
Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PVI+LA linear ablation +CFAE ablation | Active comparator | Procedure: PVI, Procedure: LA linear ablation, Procedure: CFAE ablation, Device: CARTOThe ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation. |
| PVI+linear ablation +CFAE ablation | Active comparator | Procedure: PVI, Procedure: LA linear ablation, Procedure: CFAE ablation, Procedure: linear ablation, Device: CARTOThe ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation. |
| PVI+CFAE ablation | Active comparator | Procedure: PVI, Procedure: CFAE ablation, Device: CARTOThe ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with longstanding persistent atrial fibrillation (lasting for>1 year)
- Exhibited refractoriness to at least one antiarrhythmic drug
- Left atrial diameter <=60mm
Key exclusion criteria (12 listed)
- Patients with uncontrolled congestive heart failure
- Having significant valvular disease and/or prosthetic heart valve(s)
- With myocardial infarction or stroke within 6 months of screening
- With Significant congenital heart disease;ejection fraction was <40% measured by echocardiography
- Allergic to contrast media
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 |
|---|---|---|
| PVIPVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra. | Procedure or surgery | PVI+CFAE ablation, PVI+LA linear ablation +CFAE ablation, PVI+linear ablation +CFAE ablation |
| LA linear ablationLA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs). | Procedure or surgery | PVI+LA linear ablation +CFAE ablation, PVI+linear ablation +CFAE ablation |
| CFAE ablationAblation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms. | Procedure or surgery | PVI+CFAE ablation, PVI+LA linear ablation +CFAE ablation, PVI+linear ablation +CFAE ablation |
| linear ablationRight atrial CTI ablation was performed during SR. | Procedure or surgery | PVI+linear ablation +CFAE ablation |
| CARTO3 dimensional mapping system | Device | PVI+CFAE ablation, PVI+LA linear ablation +CFAE ablation, PVI+linear ablation +CFAE ablation |
Primary outcome
Time to first documented recurrence of atrial arrhythmias
Time frame: 2-year follow-up
Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure
6 secondary outcomes
Procedure duration at ablation
Time frame: At the end of the first ablation procedure
Ablation time at ablation
Time frame: At the end of the first ablation procedure ]
Fluoroscopy time at ablation
Time frame: At the end of the first ablation procedure
Complications
Time frame: 2-year follow-up
Type of recurrent arrhythmia
Time frame: 2-year follow-up
Number of redo procedures
Time frame: 2-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- 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.
Xu Mr Liu, MD principal investigator
Shanghai Chest 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 PVI, LA linear ablation and CFAE ablation in people with Atrial Fibrillation, run by Shanghai Chest 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 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: status not confirmed, as of the sponsor's last update on 20 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanlong Mr Wang, MD (08615800719348, sdzhilong2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first documented recurrence of atrial arrhythmias (time frame: 2-year follow-up). 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 20 Oct 2016.