NCT04124328

Brief Summary

In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

October 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

October 9, 2019

Last Update Submit

August 2, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Procedural succes rate

    Mitral isthmus block rate after one pass of the mitral line

    At time of ablation

Secondary Outcomes (7)

  • Total procedure time

    At time of ablation

  • Fluoroscopy time

    At time of ablation

  • Total RF ablation time

    At time of ablation

  • Total extent of ablated LA tissue

    At time of ablation

  • Cardiovascular-related hospitalizations

    From time of ablation to one month post procedure

  • +2 more secondary outcomes

Study Arms (2)

ALINE only group

ACTIVE COMPARATOR

Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria

Procedure: ALINE only

VoM group

ACTIVE COMPARATOR

Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria and vein of Marshall (VoM) ethanol infusion

Procedure: ALINE + VoM infusion

Interventions

ALINE + VoM infusionPROCEDURE

In patients assigned to the ALINE + VoM infusion group, extended ablation will be performed according to the ALINE criteria. Additionally, the vein of Marshall will be infused with ethanol.

VoM group
ALINE onlyPROCEDURE

In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria.

ALINE only group

Eligibility Criteria

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

You may qualify if:

  • Patients between the ages of 18 and 85 years
  • Diagnosed with symptomatic AF without previous mitral isthmus line ablation

You may not qualify if:

  • Previous MI line ablation
  • Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
  • LA diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc.
  • Left ventricular ejection fraction \<35%.
  • Cardiac surgery within the previous 90 days.
  • Expecting cardiac transplantation or other cardiac surgery within 180 days.
  • Coronary PTCA/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
  • Renal insufficiency
  • Unstable angina.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

Related Publications (1)

  • Gillis K, O'Neill L, Wielandts JY, Hilfiker G, Almorad A, Lycke M, El Haddad M, le Polain de Waroux JB, Tavernier R, Duytschaever M, Knecht S. Vein of Marshall Ethanol Infusion as First Step for Mitral Isthmus Linear Ablation. JACC Clin Electrophysiol. 2022 Mar;8(3):367-376. doi: 10.1016/j.jacep.2021.11.019. Epub 2022 Feb 23.

    PMID: 35331432DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sebastien Knecht, MD, PhD

    AZ Sint-Lucas Brugge

    PRINCIPAL INVESTIGATOR

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 11, 2019

Study Start

October 15, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

BE(1)