NCT04122963

Brief Summary

In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

October 9, 2019

Last Update Submit

February 10, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Efficacy: Acute procedural success

    First pass pulmonary vein isolation confirmed after adenosine injection

    At time of ablation

  • Safety: Absence of clinical complications

    Absence of clinical complications during the procedure and up to one month thereafter

    From time of ablation to 1 month post procedure

Secondary Outcomes (12)

  • Procedural duration time

    At time of ablation

  • Duration for pulmonary vein isolation

    At time of ablation

  • Fluoroscopic duration and irradiation (AK)

    At time of ablation

  • Amount of ablation points associated with temperature rise

    At time of ablation

  • Maximum temperature in case of temperature rise

    At time of ablation

  • +7 more secondary outcomes

Study Arms (2)

High power group

ACTIVE COMPARATOR

The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).

Procedure: High power CLOSE-guided PVI ablation

Standard group

ACTIVE COMPARATOR

The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)

Procedure: Standard CLOSE-guided PVI ablation

Interventions

High power CLOSE-guided PVI ablationPROCEDURE

CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)

High power group
Standard CLOSE-guided PVI ablationPROCEDURE

Standard AF ablation according to the CLOSE-protocol

Standard group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease
  • Signed Patient Informed Consent Form
  • Age 18 years or older
  • Able and willing to comply with all follow-up testing and requirements

You may not qualify if:

  • Persistent atrial fibrillation (history of AF\>7days or history of cardioversion \> 48h of AF)
  • Previous ablation for AF
  • LA antero-posterior diameter\>50 mm (parasternal long axis view , PLAX)
  • LVEF \<35% (ejection fraction)
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • CABG procedure within the last three months
  • Awaiting cardiac transplantation or other cardiac surgery
  • Documented left atrial thrombus on imaging
  • Diagnosed atrial myxoma
  • Women who are pregnant or breastfeeding
  • Acute illness or active systemic infection or sepsis
  • Unstable angina
  • Uncontrolled heart failure
  • Myocardial infarction within the previous two months
  • History of blood clotting or bleeding abnormalities
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology

Bruges, 8000, Belgium

Location

Related Publications (1)

  • Wielandts JY, Kyriakopoulou M, Almorad A, Hilfiker G, Strisciuglio T, Phlips T, El Haddad M, Lycke M, Unger P, Le Polain de Waroux JB, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10.

    PMID: 33300809RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 10, 2019

Study Start

February 15, 2019

Primary Completion

September 25, 2019

Study Completion

June 30, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations

BE(1)