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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYantai Yuhuangding Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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%

Trial design

Design model

Parallel

Treatments tested in this trial

  • STABLE-SR

    Procedure/Surgery

    homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm

  • STABLE-AF

    Procedure/Surgery

    homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during Atrial Fibrillation

  • CPVI

    Procedure/Surgery

    ablate around the pulmonary vein orifice

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: STABLE-SRExperimental treatment 1 intervention
Group B: STABLE-AFExperimental treatment 1 intervention
Group C: CPVI aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of no atrial arrhythmias greater than 30 seconds

The incidence of no atrial arrhythmias greater than 30 seconds

Time frame
at least 18 months follow up

Secondary outcomes

1

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

Time frame
at least 18 months follow up
2

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

Time frame
at least 18 months follow up
3

Atrial fibrillation load

Atrial fibrillation load

Time frame
at least 18 months follow up
4

Procedure time

time that the patient spend in the procedure room

Time frame
Surgical procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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