Atrial FibrillationNCT06499818
CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
A study testing STABLE-SR, STABLE-AF and CPVI in people with Atrial Fibrillation, run by Yantai Yuhuangding Hospital.
Trial summary
The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- STABLE-SR, STABLE-AF and CPVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 15 Dec 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age is 18-80 years;
- Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting > 7 days;
- Patients can sign the written informed consent for the study;
- Patients can endure the required follow-up.
Who cannot join
- Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation
- Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter
- Left atrial diameter >55mm
- Left ventricular ejection fraction <35%
- Left atrial thrombus
- Postoperative cardiac surgery
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- After valve replacement
- After permanent pacemaker implantation
- hypertrophic cardiomyopathy
- Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease
- Hemorrhagic stroke within 6 months
- Transient ischemic attack or ischemic stroke within 1 month
- Mental disorder or history of mental illness and inability to cooperate voluntarily
- Breastfeeding, pregnancy and women planning or likely to become pregnant
- Life expectancy <12 months
- Participating in other interventional clinical trials
- The researchers judged that it was not suitable for inclusion in this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Circumferential Pulmonary Vein Isolation Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.
- Conditions
- Atrial Fibrillation
- Being tested
- STABLE-SR, STABLE-AF, CPVI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STABLE-SRProcedure or surgery
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm
STABLE-AFProcedure or surgery
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation
CPVIProcedure or surgery
ablate around the pulmonary vein orifice
| Study group | Role | What they receive |
|---|---|---|
| STABLE-SR | Experimental | Not described Receives: Procedure: STABLE-SR |
| STABLE-AF | Experimental | Not described Receives: Procedure: STABLE-AF |
| CPVI alone | Active comparator | Not described Receives: Procedure: CPVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of no atrial arrhythmias greater than 30 seconds
The incidence of no atrial arrhythmias greater than 30 seconds
Measured: at least 18 months follow up
Secondary outcomes (6)
No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds
No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds
Measured: at least 18 months follow up
No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds
No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds
Measured: at least 18 months follow up
Atrial fibrillation load
Atrial fibrillation load
Measured: at least 18 months follow up
Procedure time
time that the patient spend in the procedure room
Measured: Surgical procedure
Ablation time
the total Ablation time, during CPVI and after CPVI
Measured: 1 week after patient enrollment
Incidence of peri-procedural complications
stroke, PV stenosis, cardiac perforation, esophageal injury and death
Measured: at least 18 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499818
- Sponsor's protocol ID
- 2024-226
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Pulmonary Vein Isolation Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
- ClinicalTrials.gov ID
- NCT06499818
- Acronym / sponsor ID
- 2024-226
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 Jul 2024 (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.
The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STABLE-SR | Experimental | Procedure: STABLE-SR |
| STABLE-AF | Experimental | Procedure: STABLE-AF |
| CPVI alone | Active comparator | Procedure: CPVI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age is 18-80 years;
- Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting > 7 days;
- Patients can sign the written informed consent for the study;
- Patients can endure the required follow-up.
Key exclusion criteria (17 listed)
- Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation
- Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter
- Left atrial diameter >55mm
- Left ventricular ejection fraction <35%
- Left atrial thrombus
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 |
|---|---|---|
| STABLE-SRhomogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm | Procedure or surgery | STABLE-SR |
| STABLE-AFhomogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation | Procedure or surgery | STABLE-AF |
| CPVIablate around the pulmonary vein orifice | Procedure or surgery | CPVI alone |
Primary outcome
The incidence of no atrial arrhythmias greater than 30 seconds
Time frame: at least 18 months follow up
The incidence of no atrial arrhythmias greater than 30 seconds
6 secondary outcomes
No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds
Time frame: at least 18 months follow up
No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds
Time frame: at least 18 months follow up
Atrial fibrillation load
Time frame: at least 18 months follow up
Procedure time
Time frame: Surgical procedure
Ablation time
Time frame: 1 week after patient enrollment
Incidence of peri-procedural complications
Time frame: at least 18 months follow up
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 15 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing STABLE-SR, STABLE-AF and CPVI in people with Atrial Fibrillation, run by Yantai Yuhuangding Hospital.
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 17 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: opening soon, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Hongxia Chu, doctorate (15965165932, chuhx1972@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of no atrial arrhythmias greater than 30 seconds (time frame: at least 18 months 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 15 Jul 2024.