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
NCT ID: NCT06499818
Last Updated: 2024-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-07-15
2026-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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STABLE-SR
STABLE-SR
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm
STABLE-AF
STABLE-AF
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation
CPVI alone
CPVI
ablate around the pulmonary vein orifice
Interventions
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STABLE-SR
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm
STABLE-AF
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation
CPVI
ablate around the pulmonary vein orifice
Eligibility Criteria
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Inclusion Criteria
2. Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days;
3. Patients can sign the written informed consent for the study;
4. Patients can endure the required follow-up.
Exclusion Criteria
2. Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter
3. Left atrial diameter \>55mm
4. Left ventricular ejection fraction \<35%
5. Left atrial thrombus
6. Postoperative cardiac surgery
7. After valve replacement
8. After permanent pacemaker implantation
9. hypertrophic cardiomyopathy
10. Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease
11. Hemorrhagic stroke within 6 months
12. Transient ischemic attack or ischemic stroke within 1 month
13. Mental disorder or history of mental illness and inability to cooperate voluntarily
14. Breastfeeding, pregnancy and women planning or likely to become pregnant
15. Life expectancy \<12 months
16. Participating in other interventional clinical trials
17. The researchers judged that it was not suitable for inclusion in this study
18 Years
80 Years
ALL
Yes
Sponsors
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Yantai Yuhuangding Hospital
OTHER
Responsible Party
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Central Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2024-226
Identifier Type: -
Identifier Source: org_study_id
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