Persistent Atrial Fibrillation Ablation Trial (PAAT)

This study has suspended participant recruitment.
(Internal protocol review)
Sponsor:
Information provided by (Responsible Party):
Neil Sulke, Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01891825
First received: June 29, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Surgical AF ablation
Procedure: Percutaneous AF ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Persistent Atrial Fibrillation Ablation Trial

Resource links provided by NLM:


Further study details as provided by Eastbourne General Hospital:

Primary Outcome Measures:
  • Recurrence of persistent AF by 12 months after ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean time to recurrence of persistent AF after ablation


Secondary Outcome Measures:
  • Change in AF burden after AF ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Detected by ILR

  • Time to first episode of symptomatic AF after ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to first episode of symptomatic AF after ablation

  • Time to first episode of any AF after ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    As detected by ILR

  • Total number of AF episodes after AF ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    As detected by ILR, outside blanking period

  • Total number of AF episodes lasting greater than 6 minutes after AF ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    As detected by ILR, outside blanking period

  • New MRI-detected subclinical cerebral embolic events [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Quality of life changes after AF ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in echocardiographic left atrial dimensions and function after AF ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in cognitive function as assessed by the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) instruments [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891825

Locations
United Kingdom
Eastbourne General Hospital
Eastbourne, E Sussex, United Kingdom, BN21 2UD
Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Sponsors and Collaborators
Neil Sulke
Investigators
Principal Investigator: Neil Sulke, DM Eastbourne General Hospital
  More Information

No publications provided

Responsible Party: Neil Sulke, Principal Investigator, Eastbourne General Hospital
ClinicalTrials.gov Identifier: NCT01891825     History of Changes
Other Study ID Numbers: PAAT
Study First Received: June 29, 2013
Last Updated: June 25, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Eastbourne General Hospital:
Atrial fibrillation
Persistent atrial fibrillation
Atrial fibrillation ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014