NCT05195268

Brief Summary

RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

November 19, 2021

Last Update Submit

September 27, 2022

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationPosterior wall isolationAblationPersistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Time to first day with ATA burden of 12 hours or greater

    Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation

    From 3 months post ablation to 12 months

Secondary Outcomes (9)

  • Time to first day with ATA burden of 24 hours

    From 3 months post ablation to 12 months

  • Time to first day with ATA burden of 60 minutes or greater

    From 3 months post ablation to 12 months

  • Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12

    12 months

  • Reduction in burden of AF between pre-ablation and months 3-12

    12 months

  • Difference in AFEQT questionnaire between baseline and month 12

    12 months

  • +4 more secondary outcomes

Other Outcomes (2)

  • Safety Outcome: Number of patients with procedural complications (<2 months post procedure)

    Within 2 months of protocol-required invasive procedures

  • Safety Outcome: Number of patients undergoing planned and unplanned cardiovascular-related hospitalisations

    12 months

Study Arms (2)

Group 1 - PVI + PWI

ACTIVE COMPARATOR

These patients will receive pulmonary vein isolation and posterior wall isolation.

Procedure: Intracardiac Catheter Ablation

Group 2 - PVI only

OTHER

These patients will receive pulmonary vein isolation only.

Procedure: Intracardiac Catheter Ablation

Interventions

Intracardiac Catheter AblationPROCEDURE

Both arms will receive intracardiac catheter ablation procedures as described.

Group 1 - PVI + PWIGroup 2 - PVI only

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 80 (inclusive)
  • Patients with symptomatic advanced persistent AF, defined as:
  • AF which does not spontaneously terminate and requires medical intervention (antiarrhythmics or DCCV) to terminate, AND
  • Recurs following cardioversion, AND
  • Is associated with evidence of left atrial cardiopathy, defined as at least mild left atrial enlargement on imaging (echo, CT or MRI) as defined by standard values (for example British Society of Echocardiography or European equivalent) - in the event of uncertainty, Principal Investigator discretion is allowed.

You may not qualify if:

  • Any previous catheter (or surgical) ablation for AF (previous ablation for atrial flutter or focal atrial tachycardias are allowable)
  • An indwelling atrial septal defect occluder device or anatomical structure that pre-vents free access to the left atrium
  • Severe left ventricular systolic dysfunction (ejection fraction less than 35%)
  • Recent stroke/transient ischaemic attack within 3 months
  • Inability, unwillingness or absolute contraindication to taking an oral anticoagulant medication
  • Severe kidney function impairment (eGFR less than 30ml/min/1.73m2)
  • Morbid obesity with a body mass index ≥40
  • Extreme frailty (a score of 7,8 or 9 on the Rockwood Clinical Frailty Scale)
  • Severe valvular heart disease of any kind as assessed by the investigator, with or without a prosthetic valve in place
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Heart & Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dhiraj Gupta, MD

    Liverpool Heart & Chest Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients and operators will be aware of the treatment arm. Researchers interpreting and assessing outcome data will be blinded to treatment received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2021

First Posted

January 18, 2022

Study Start

July 1, 2022

Primary Completion

September 12, 2022

Study Completion

September 12, 2022

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)