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

NCT04784013 | Completed Phase 4

• 1 other identifier: 2800
• Study Type: interventional
• Target: 182
• Locations: 4 countries
• Sites: 4

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Procedural time

  Comparison of the procedural time (in minutes) between groups

  Procedure (At time of ablation)

Secondary Outcomes (4)

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

  Months 4-6 after ablation

• Radiofrequency (RF) ablation time

  Procedure (At time of ablation)

• Fluoroscopy dose

  Procedure (At time of ablation)

• First pass isolation rate

  Procedure (At time of ablation)

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

Procedure: Conventional CLOSE-guided pulmonary vein isolation

90W-group

ACTIVE COMPARATOR

Procedure: High power short duration pulmonary vein isolation

Interventions

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.

Conventional group

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.

90W-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (4)

Medical University Hospital Graz

Graz, Austria

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, Please Select, 8000, Belgium

Location

UMC Leiden

Leiden, Netherlands

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Related Publications (1)

• O'Neill L, El Haddad M, Berte B, Kobza R, Hilfiker G, Scherr D, Manninger M, Wijnmaalen AP, Trines SA, Wielandts JY, Gillis K, Lycke M, De Becker B, Tavernier R, Le Polain De Waroux JB, Knecht S, Duytschaever M. Very High-Power Ablation for Contiguous Pulmonary Vein Isolation: Results From the Randomized POWER PLUS Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):511-522. doi: 10.1016/j.jacep.2022.10.039. Epub 2023 Jan 18.

  PMID: 36752467 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Mattias Duytschaever, MD, PhD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: March 24, 2021
• Primary Completion: October 22, 2021
• Study Completion: May 31, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

AU (1); CH (1); NL (1); BE (1)