search
Back to results

Persistent Atrial Fibrillation Ablation Trial (PAAT)

Primary Purpose

Atrial Fibrillation

Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surgical AF ablation
Percutaneous AF ablation
Sponsored by
Neil Sulke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Persistent atrial fibrillation, Atrial fibrillation ablation

Eligibility Criteria

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

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

Sites / Locations

  • Eastbourne General Hospital
  • Royal Sussex County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pecutaneous AF ablation

Surgical AF ablation

Arm Description

Percutaneous catheter ablation of atrial fibrillation

Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

Outcomes

Primary Outcome Measures

Recurrence of persistent AF by 12 months after ablation
Mean time to recurrence of persistent AF after ablation

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2013
Last Updated
June 25, 2014
Sponsor
Neil Sulke
search

1. Study Identification

Unique Protocol Identification Number
NCT01891825
Brief Title
Persistent Atrial Fibrillation Ablation Trial
Acronym
PAAT
Official Title
Persistent Atrial Fibrillation Ablation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Suspended
Why Stopped
Internal protocol review
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neil Sulke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Persistent atrial fibrillation, Atrial fibrillation ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pecutaneous AF ablation
Arm Type
Active Comparator
Arm Description
Percutaneous catheter ablation of atrial fibrillation
Arm Title
Surgical AF ablation
Arm Type
Active Comparator
Arm Description
Minimally invasive thoracoscopic surgical ablation of atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
Surgical AF ablation
Intervention Description
Minimally invasive thoracoscopic surgical ablation of atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
Percutaneous AF ablation
Intervention Description
Percutaneous catheter ablation of atrial fibrillation
Primary Outcome Measure Information:
Title
Recurrence of persistent AF by 12 months after ablation
Description
Mean time to recurrence of persistent AF after ablation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in AF burden after AF ablation
Description
Detected by ILR
Time Frame
12 months
Title
Time to first episode of symptomatic AF after ablation
Description
Time to first episode of symptomatic AF after ablation
Time Frame
12 months
Title
Time to first episode of any AF after ablation
Description
As detected by ILR
Time Frame
12 months
Title
Total number of AF episodes after AF ablation
Description
As detected by ILR, outside blanking period
Time Frame
12 months
Title
Total number of AF episodes lasting greater than 6 minutes after AF ablation
Description
As detected by ILR, outside blanking period
Time Frame
12 months
Title
New MRI-detected subclinical cerebral embolic events
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Quality of life changes after AF ablation
Time Frame
12 months
Title
Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation
Time Frame
12 months
Title
Change in echocardiographic left atrial dimensions and function after AF ablation
Time Frame
12 months
Title
Change in cognitive function as assessed by the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) instruments
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Sulke, DM
Organizational Affiliation
Eastbourne General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastbourne General Hospital
City
Eastbourne
State/Province
E Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Persistent Atrial Fibrillation Ablation Trial

We'll reach out to this number within 24 hrs