Persistent Atrial Fibrillation Ablation Trial (PAAT)

June 25, 2014 updated by: Neil Sulke
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • E Sussex
      • Eastbourne, E Sussex, United Kingdom, BN21 2UD
        • Eastbourne General Hospital
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic persistent or long-standing AF suitable for AF ablation.
  • Age over 18 years old.
  • Informed consent to participate in this study.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pecutaneous AF ablation
Percutaneous catheter ablation of atrial fibrillation
Procedure: Percutaneous AF ablation
Percutaneous catheter ablation of atrial fibrillation
Active Comparator: Surgical AF ablation
Minimally invasive thoracoscopic surgical ablation of atrial fibrillation
Procedure: Surgical AF ablation
Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of persistent AF by 12 months after ablation
Time Frame: 12 months
Mean time to recurrence of persistent AF after ablation
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AF burden after AF ablation
Time Frame: 12 months
Detected by ILR
12 months
Time to first episode of symptomatic AF after ablation
Time Frame: 12 months
Time to first episode of symptomatic AF after ablation
12 months
Time to first episode of any AF after ablation
Time Frame: 12 months
As detected by ILR
12 months
Total number of AF episodes after AF ablation
Time Frame: 12 months
As detected by ILR, outside blanking period
12 months
Total number of AF episodes lasting greater than 6 minutes after AF ablation
Time Frame: 12 months
As detected by ILR, outside blanking period
12 months
New MRI-detected subclinical cerebral embolic events
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life changes after AF ablation
Time Frame: 12 months
12 months
Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation
Time Frame: 12 months
12 months
Change in echocardiographic left atrial dimensions and function after AF ablation
Time Frame: 12 months
12 months
Change in cognitive function as assessed by the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) instruments
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neil Sulke

Investigators

  • Principal Investigator: Neil Sulke, DM, Eastbourne General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

June 29, 2013

First Submitted That Met QC Criteria

June 29, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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