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Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF (RABLAP-AF)

Primary Purpose

Atrial Fibrillation

Status

Withdrawn

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Intracardiac Catheter Ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Posterior wall isolation, Ablation, Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion Criteria

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

Sites / Locations

Liverpool Heart & Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Group 1 - PVI + PWI

Group 2 - PVI only

Arm Description

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

These patients will receive pulmonary vein isolation only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first day with ATA burden of 24 hours

Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation

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

Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation

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

AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the number of patients who achieve greater than or equal to 75% reduction.

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

AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the average % reduction in AF burden between these time periods.

Difference in AFEQT questionnaire between baseline and month 12

Differences in quality of life indicators as measured by the "AF Effect on QualiTy of life survey" (AFEQT) between baseline and 12 month follow-up

Difference in EQ5D questionnaire between baseline and month 12

Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up

Difference in VAS between baseline and month 12

Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up

Use of antiarrhythmic drugs from month 3 onwards

Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.

Use of direct current cardioversion or repeat ablation

Number of patients requiring cardioversion or repeat ablation

Full Information

NCT ID

NCT05195268

First Posted

November 19, 2021

Last Updated

September 27, 2022

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborators

Biosense Webster, Inc., Royal Brompton & Harefield NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, University Hospital Plymouth NHS Trust, South Tees Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Papworth Hospital NHS Foundation Trust, Portsmouth Hospitals NHS Trust, University Hospitals Dorset NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Onze Lieve Vrouw Hospital, AZ Sint-Jan AV, University of Liverpool

1. Study Identification

Unique Protocol Identification Number

NCT05195268

Brief Title

Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

Acronym

RABLAP-AF

Official Title

Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Decision to discontinue in light of new evidence demonstrating that the intervention in question is not effective.

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

September 12, 2022 (Actual)

Study Completion Date

September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF. A common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF. The investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Atrial Fibrillation, Posterior wall isolation, Ablation, Persistent Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone

Masking

Outcomes Assessor

Masking Description

Patients and operators will be aware of the treatment arm. Researchers interpreting and assessing outcome data will be blinded to treatment received.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - PVI + PWI

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 2 - PVI only

Arm Type

Other

Arm Description

These patients will receive pulmonary vein isolation only.

Intervention Type

Procedure

Intervention Name(s)

Intracardiac Catheter Ablation

Intervention Description

Both arms will receive intracardiac catheter ablation procedures as described.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

From 3 months post ablation to 12 months

Secondary Outcome Measure Information:

Title

Time to first day with ATA burden of 24 hours

Description

Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation

Time Frame

From 3 months post ablation to 12 months

Title

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

Description

Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation

Time Frame

From 3 months post ablation to 12 months

Title

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

Description

Time Frame

12 months

Title

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

Description

Time Frame

12 months

Title

Difference in AFEQT questionnaire between baseline and month 12

Description

Differences in quality of life indicators as measured by the "AF Effect on QualiTy of life survey" (AFEQT) between baseline and 12 month follow-up

Time Frame

12 months

Title

Difference in EQ5D questionnaire between baseline and month 12

Description

Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up

Time Frame

12 months

Title

Difference in VAS between baseline and month 12

Description

Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up

Time Frame

12 months

Title

Use of antiarrhythmic drugs from month 3 onwards

Description

Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.

Time Frame

From 3 months post ablation to 12 months

Title

Use of direct current cardioversion or repeat ablation

Description

Number of patients requiring cardioversion or repeat ablation

Time Frame

From 3 months post ablation to 12 months

Other Pre-specified Outcome Measures:

Title

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

Description

Number of patients suffering a procedure-related complication within 2 months of an invasive procedure as defined in the study protocol

Time Frame

Within 2 months of protocol-required invasive procedures

Title

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

Description

Number of patients who are hospitalised (planned or unplanned) for cardiovascular reasons

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion Criteria 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dhiraj Gupta, MD

Organizational Affiliation

Liverpool Heart & Chest Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Liverpool Heart & Chest Hospital

City

Liverpool

ZIP/Postal Code

L14 3PE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

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