NCT02528604

Brief Summary

Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

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

August 18, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

August 18, 2015

Last Update Submit

September 26, 2018

Conditions

Persistent Atrial Fibrillation

Keywords

Catheter AblationPermanent pacemakerAV node ablationElectrical CardioversionImplantable loop recorder

Outcome Measures

Primary Outcomes (1)

  • AF recurrence

    Time to recurrence of persistent AF

    12 months

Secondary Outcomes (7)

  • Patient experience of procedure

    Baseline

  • Total costs of the treatment options

    12 months

  • AF recurrence >2minutes

    12 months

  • Symptoms / QOL

    12 months

  • Exercise performance

    12 months

  • +2 more secondary outcomes

Study Arms (3)

Catheter Ablation

ACTIVE COMPARATOR

Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder.

Procedure: Catheter ablationDevice: Implantable loop recorder

Pacemaker and AV node ablation

ACTIVE COMPARATOR

Participants will have a permanent pacemaker implant followed by AV node ablation

Procedure: Pacemaker and AV node ablation

DC cardioversion

ACTIVE COMPARATOR

Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder.

Procedure: DC CardioversionDevice: Implantable loop recorder

Interventions

Catheter ablationPROCEDURE

Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.

Catheter Ablation
Pacemaker and AV node ablationPROCEDURE

Permanent pacemaker implant followed by AV node ablation

Pacemaker and AV node ablation
DC CardioversionPROCEDURE

Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.

DC cardioversion
Implantable loop recorderDEVICE
Catheter AblationDC cardioversion

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic persistent atrial fibrillation of less than 1-year duration.
  • Patients must be over 65 years old.
  • Patients give informed consent prior to participating in this study.

You may not qualify if:

  • Paroxysmal atrial fibrillation.
  • Long-standing persistent or permanent atrial fibrillation.
  • Previous pacemaker implantation.
  • Previous atrial ablation.
  • Patient is unable to take warfarin or other oral anti-coagulant medication.
  • Patient is suffering with unstable angina in last one week.
  • Patient has had a myocardial infarction within last two months.
  • Patient is expecting or has had major cardiac surgery within last two months.
  • Patient is participating in a conflicting study.
  • Patient is unable to perform exercise testing.
  • Patient is mentally incapacitated and cannot consent or comply with follow-up.
  • Patient has New York Heart Association (NYHA) class III/IV heart failure.
  • Patient has left ventricular ejection fraction (LVEF) less than 35% not secondary to tachycardia.
  • Pregnancy.
  • Patient suffers with other cardiac rhythm disorders.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eastbourne District General Hospital

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

Conquest Hospital

Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Rick A Veasey, MRCP, MD

    Consultant Cardiologist

    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
Consultant Cardiologist

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 19, 2015

Study Start

July 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

GB(2)