CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the … (NCT03448562) | Clinical Trial Compass
UnknownNot Applicable
CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF
China300 participantsStarted 2018-04-01
Plain-language summary
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients with previous radiofrequency ablation;
* Patients with PLT count less than 80×109/L, or with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor;
* Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view);
* Patients with thromboemboli in LA (TEE or MSCT);
* Patients with severe structural cardiac disease (medium or severe mitral regurgitation, DCM, HCM, or other severe valvular heart diseases);
* Patients with abnormal thyroid function;
* Patients with severe liver or renal dysfunction (AST or ALT \> 3-fold of upper limit value; the SCr \> 3.5 mg/dl or Ccr \< 30 ml/min);
* Previous surgery history in last 3 months;
* Patients with life expectancy \< 12 months; and
* Patients who are pregnant.
What they're measuring
1
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs)
Timeframe: at least 12 months follow up
Trial details
NCT IDNCT03448562
SponsorThe First Affiliated Hospital with Nanjing Medical University