NCT01891825

Brief Summary

Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

Status
suspended

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

June 29, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

June 29, 2013

Last Update Submit

June 25, 2014

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationPersistent atrial fibrillationAtrial fibrillation ablation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of persistent AF by 12 months after ablation

    Mean time to recurrence of persistent AF after ablation

    12 months

Secondary Outcomes (6)

  • Change in AF burden after AF ablation

    12 months

  • Time to first episode of symptomatic AF after ablation

    12 months

  • Time to first episode of any AF after ablation

    12 months

  • Total number of AF episodes after AF ablation

    12 months

  • Total number of AF episodes lasting greater than 6 minutes after AF ablation

    12 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Quality of life changes after AF ablation

    12 months

  • Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation

    12 months

  • Change in echocardiographic left atrial dimensions and function after AF ablation

    12 months

  • +1 more other outcomes

Study Arms (2)

Pecutaneous AF ablation

ACTIVE COMPARATOR

Percutaneous catheter ablation of atrial fibrillation

Procedure: Percutaneous AF ablation

Surgical AF ablation

ACTIVE COMPARATOR

Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

Procedure: Surgical AF ablation

Interventions

Surgical AF ablationPROCEDURE

Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

Surgical AF ablation
Percutaneous AF ablationPROCEDURE

Percutaneous catheter ablation of atrial fibrillation

Pecutaneous AF ablation

Eligibility Criteria

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

You may qualify if:

  • Symptomatic persistent or long-standing AF suitable for AF ablation.
  • Age over 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, East Sussex, BN2 5BE, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Sulke, DM

    Eastbourne General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2013

First Posted

July 3, 2013

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

GB(2)