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NCT Number: NCT06516822

CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)

Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial.

The SINUS study is a prospective, multicenter, randomized trial, which is designed to compare the efficacy and safety between CPVI with modified linear ablation (CPVI-MLA) and CPVI only for the treatment of LSPAF.

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Key information

Conditions

Long-standing Persistent Atrial Fibrillation Ablation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

The SINUS study will include 320 patients with LSPAF undergoing catheter ablation for the first time. All patients will be randomized to either the CPVI-MLA group or CPVI only group in a 1:1 ratio. The CPVI-MLA strategy is a fixed ablation approach consisting of EI-VOM, CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI). The follow-up is for a minimum of 12 months with rhythm monitoring. The primary endpoint is freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), at 12 months after the index ablation procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year;
  • AF duration 1-3 years;
  • Age 18 - 75 years;
  • Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;
  • AF recorded within 3 years of enrollment;
  • Patient willing and able to comply with protocol and sign informed consent

Exclusion criteria

  • Paroxysmal atrial fibrillation;
  • Persistent AF lasting < 1 year or >3 years;
  • Left atrial thrombosis;
  • Patients with a history of catheter ablation for AF;
  • Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);
  • LAD > 55mm on long axis parasternal view;
  • Left ventricular ejection fraction (LVEF) < 40%;
  • Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
  • One-stop procedure for AF ablation and left atrial appendage occlusion;
  • Alcohol allergy or contrast agent allergy;
  • Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
  • Pulmonary artery systolic pressure > 50mmHg;
  • Patients with unstable angina pectoris;
  • Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
  • Patients who had undergone surgery within 6 months;
  • Patients ready to receive heart transplantation;
  • Patients with a history of thromboembolism within 6 months;
  • Patients with diagnosed atrial myxoma;
  • Patients with severe respiratory diseases;
  • Patients with infectious diseases in active phase;
  • Patients with poorly controlled systemic immune diseases;
  • Patients with uncured malignant hematological diseases;
  • Patients with uncured malignant solid tumors;
  • Patients with untreated hypothyroidism or hyperthyroidism;
  • Patients with severe liver dysfunction (elevation of transaminases [ALT or AST] >3 times the upper limit of normal range);
  • Patients with end-stage renal failure requiring dialysis;
  • Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
  • Pregnant and lactating women;
  • Patients with psychiatric ailments;
  • BMI < 18.5 or ≥ 30kg/m2;
  • Life expectancy < 2 years;
  • Patients unwilling or unable to give informed consent;
  • Patients unwilling or unable to cooperate to complete follow-up.

Treatment and study plan

CPVI-MLA

Procedure

The details include: (1) EI-VOM procedure: An 8.5-French-long sheath is inserted into to the CS via the femoral vein. A JR4 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a guide wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated at 6-8 atm pressure in the VOM. Ethanol is infused into VOM from distal to proximal with 3ml each time within 1-2min. After the distal EI-VOM, the balloon is deflated and adjusted to the middle part of VOM. The EI-VOM procedure in the proximal and middle part of VOM should be the same as that in the distal. After three times of EI-VOM, the contrast is injected into VOM to make it permeable and dispersed to observe the effect of alcohol ablation. (2) After EI-VOM, radiofrequency ablation is performed to achieve bilateral PVI, PWI, bidirectional block of MI and CTI, disappearance of LAI-CS potential and SVCI. (3) Any organized AT observed during the procedure is targeted as well.

CPVI only

Procedure

After reconstructing the left atrial geometry, CPVI is performed. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia for PVI to achieve a wide PVI ring. The mapping catheter PentaRay will be used to confirm the complete isolation of the PV antrum when all PV potentials within each antrum are abolished. If the AF persists after CPVI, direct current cardioversion is then be conducted to restore sinus rhythm. If spontaneous AFL/AT occurs during ablation, ablation is performed targeting the focal or critical isthmus under the guidance of high-density activation mapping. The endpoint of CPVI is to achieve complete entrance and exit block of all PV antra as recorded by PentaRay during sinus rhythm or CS pacing.

Primary outcomes

  1. Freedom from any documented atrial arrhythmia off AADs

    Time frame: 12 months

    Freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds assessed by ECG and Holter after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), after the index ablation procedure

Secondary outcomes

  1. Freedom from any documented atrial arrhythmia on/off AADs

    Time frame: 12 months

    Freedom from any documented atrial arrhythmia > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.

  2. Freedom from any documented AF on/off AADs

    Time frame: 12 months

    Freedom from any documented AF episodes > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.

  3. Freedom from any documented AFL/AT on/off AADs

    Time frame: 12 months

    Freedom from any documented AFL/AT episodes > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.

  4. AF burden

    Time frame: 12 months

    AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period.

  5. Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM

    Time frame: 12 months

    Freedom from any documented AFL/AT episodes > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs in patients with successful EI-VOM.

  6. AF burden in patients with successful EI-VOM

    Time frame: 12 months

    AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period in patients with successful EI-VOM

  7. Freedom from AF/AFL/AT after multiple procedures

    Time frame: 12 months

    Freedom from any documented atrial arrhythmia > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.

  8. Freedom from AF after multiple procedures

    Time frame: 12 months

    Freedom from any documented AF > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.

  9. Freedom from AFL/AT after multiple procedures

    Time frame: 12 months

    Freedom from any documented AFL/AT > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.

  10. AF burden after multiple procedures

    Time frame: 12 months

    AF burden (% time) on continuous monitoring during 12 months (after the 3-months blanking period) after multiple procedures

  11. Hospitalization for cardiovascular disease

    Time frame: 12 months

    Hospitalization for cardiovascular disease (e.g., atrial arrhythmia, heart failure and coronary heart disease)

  12. AFEQT score change between baseline and 12-month

    Time frame: 12 months

    Quality of life assessed by AF effect on quality-of-life (AFEQT) questionnaire

  13. EQ-5D-5L score change between baseline and 12-month

    Time frame: 12 months

    Quality of life assessed by EuroQol 5-dimension (EQ-5D-5L) scale

  14. Incidence of procedural complications

    Time frame: Within 3 months after the procedure

    Cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, death, stroke / thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).

Study contacts

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

Qiushi Chen, MD

CONTACT

[email protected]

Yan Dong, MD

CONTACT

[email protected]

+86 18651908170

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)

Acronym: SINUS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2024
Registry last updated
Nov 8, 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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