NCT01504451

Brief Summary

This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

December 30, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

3 years

First QC Date

December 30, 2011

Last Update Submit

June 25, 2014

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial fibrillationAblationImplantable loop recorder

Outcome Measures

Primary Outcomes (1)

  • AF burden

    Total proportion of time spent in AF as assessed by ILR

    12 months after ablation

Secondary Outcomes (3)

  • Time to AF recurrence

    Up to one year

  • Time to first symptomatic AF recurrence

    Up to one year

  • Change in QoL measures

    12 months after ablation

Study Arms (3)

Biosense Webster ablation

ACTIVE COMPARATOR

Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation

Device: ILR insertionProcedure: AF ablation

Surgical ablation

ACTIVE COMPARATOR

Minimally invasive thoracoscopic surgical AF ablation

Device: ILR insertionProcedure: AF ablation

Medtronic ablation

ACTIVE COMPARATOR

Medtronic multi-electrode phased radiofrequency AF ablation

Device: ILR insertionProcedure: AF ablation

Interventions

ILR insertionDEVICE

Insertion of implantable loop recorder

Biosense Webster ablationMedtronic ablationSurgical ablation
AF ablationPROCEDURE

AF ablation

Biosense Webster ablationMedtronic ablationSurgical ablation

Eligibility Criteria

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

You may qualify if:

  • Symptomatic paroxysmal AF suitable for AF ablation
  • Age \> 18 years old
  • Informed consent to participate in this study.

You may not qualify if:

  • Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
  • Unable to undergo general anaesthesia for AF ablation.
  • Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
  • Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
  • Previous thoracic surgery.
  • Participation in a conflicting study.
  • Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
  • Pregnancy
  • Other cardiac rhythm disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eastbourne General Hospital

Eastbourne, E Sussex, BN21 2UD, United Kingdom

Location

Royal Sussex County Hospital

Brighton, Sussex, BN2 5BE, United Kingdom

Location

Related Publications (1)

  • Sugihara C, Furniss S, Hyde J, Lewis M, Sulke N. Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation. Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.

    PMID: 29092038DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Sulke, MD

    Eastbourne General Hospital

    PRINCIPAL INVESTIGATOR

  • Stephen S Furniss, MD

    Eastbourne General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Cardiologist

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 5, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

GB(2)