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OpenTrials
Completed

NCT Number: NCT04784013

Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation

This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Hospital Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18 years
  • Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or <7days) or persistent AF (persistent AF is defined as having an AF episode >7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)
  • Patients willing to sign informed consent

Exclusion criteria

  • Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode >1yr)
  • Previous ablation for AF
  • Left atrium antero-posterior diameter >50 mm (parasternal long axis view, PLAX)
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
  • Left ventricular ejection fraction <35%.
  • Cardiac surgery within the previous 90 days.
  • Expecting cardiac transplantation or other cardiac surgery within 180 days.
  • Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
  • Documented history of a thromboembolic event within the previous 90 days.
  • Diagnosed atrial myxoma.
  • Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
  • Women who are pregnant or who plan to become pregnant during the study.
  • Acute illness or active infection at time of index procedure
  • Advanced renal insufficiency
  • Unstable angina.
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation.
  • Life expectancy less than 1 year.
  • Presence of a condition that precludes vascular access.
  • Unwilling or unable to provide informed consent.

Treatment and study plan

Conventional CLOSE-guided pulmonary vein isolation

Procedure

Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall.

High power short duration pulmonary vein isolation

Procedure

Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall.

Primary outcomes

  1. Procedural time

    Time frame: Procedure (At time of ablation)

    Comparison of the procedural time (in minutes) between groups

Secondary outcomes

  1. Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation

    Time frame: Months 4-6 after ablation

    Atrial tachyarrhythmia will be monitored by Holter

  2. Radiofrequency (RF) ablation time

    Time frame: Procedure (At time of ablation)

    Comparison of the RF ablation time (in seconds) between groups

  3. Fluoroscopy dose

    Time frame: Procedure (At time of ablation)

    Comparison of the fluoroscopy dose (Gy cm²) between groups

  4. First pass isolation rate

    Time frame: Procedure (At time of ablation)

    Reconnection of the veins after adenosine injection or waiting time

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study title

Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study

Acronym: POWER-PLUS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Jun 21, 2022

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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