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NCT Number: NCT06499818

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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
  • 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

Treatment and study plan

STABLE-SR

Procedure

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

STABLE-AF

Procedure

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

CPVI

Procedure

ablate around the pulmonary vein orifice

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 fibrillation exceeding 30 seconds

  2. No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter 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

  3. Atrial fibrillation load

    Time frame: at least 18 months follow up

    Atrial fibrillation load

  4. Procedure time

    Time frame: Surgical procedure

    time that the patient spend in the procedure room

  5. Ablation time

    Time frame: 1 week after patient enrollment

    the total Ablation time, during CPVI and after CPVI

  6. Incidence of peri-procedural complications

    Time frame: at least 18 months follow up

    stroke, PV stenosis, cardiac perforation, esophageal injury and death

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxia Chu, doctorate

CONTACT

[email protected]

15965165932

Sponsors and collaborators

Lead sponsor

Yantai Yuhuangding Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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