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Completed

NCT Number: NCT04497376

Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation

Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

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About this study

The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients must meet all the following criteria to be included in the study:

  • age between 18 and 80,
  • patients undergoing a first-time ablation procedure for non-valvular AF,
  • patients with defined as a sustained episode more than 3 months
  • PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
  • patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
  • AF refractory to at least one AAD,
  • willingness, ability and commitment to provide informed consent and participate in follow-up evaluations.

Exclusion criteria

Patients are to be excluded if any of the following criteria is met：

  • patients with paroxysmal AF,
  • patients with AF secondary to an obvious reversible cause,
  • patients with left atrial diameter ≥ 60 mm in the parasternal long axis view,
  • left ventricular ejection fraction (LVEF) < 30%,
  • patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days),
  • patients with contraindication to anticoagulation,
  • patients with contraindication to right or left sided heart catheterization,
  • pregnancy,
  • life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
  • patients cannot be removed from antiarrhythmic drugs for reasons other than AF.

Treatment and study plan

upgraded '2C3L'

Procedure

Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.

Other names: EI-VOM+2C3L

pulmonary vein antral isolation

Procedure

After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) in a wide area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.

Other names: PVI

Primary outcomes

  1. The recurrence rate of atrial tachycardia arrhythmias

    Time frame: 1 year

    freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.

Secondary outcomes

  1. Freedom from AF/AT with or without AADs

    Time frame: 1 year

    Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure.

  2. Freedom from AF/AT off AADs

    Time frame: 1 year

    Recurrent AT/AFL over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD

  3. Freedom from AF off AADs

    Time frame: 1 year

    Recurrent AF over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD

  4. AF burden

    Time frame: 1 year

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

  5. Freedom from AF/AT after multiple procedures

    Time frame: 1 year

    freedom from any documented atrial arrhythmia (AF, AT, and AFL) of more than 30 seconds, after repeated ablation1 or 2 ablation procedures, including AF, AT, and AFL, for more than 30 seconds on/off AADs.

  6. Incidence of procedural complications

    Time frame: Within 1 month after the procedure

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

  7. AFEQT score change between baseline and 12 month

    Time frame: 1 year

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

  8. EQ5D score change between baseline and 12 month

    Time frame: 1 year

    Quality of life assessed by EuroQol 5-dimension (EQ5D) scale

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

  • Fukuoka University
  • Heart Health Research Centre
  • The George Institute for Global Health, Australia
  • The George Institute for Global Health, China

Registry information

Official study title

Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation

Acronym: PROMPT-AF

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2020
Registry last updated
Jul 19, 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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