Persistent Atrial Fibrillation Ablation Trial (PAAT)

This study is not yet open for participant recruitment.
Verified June 2013 by Eastbourne General Hospital
Sponsor:
Information provided by (Responsible Party):
Neil Sulke, Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01891825
First received: June 29, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  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 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891825

Contacts
Contact: Conn Sugihara, MBBS +44 1323 417400 ext 5869 conn.sugihara@esht.nhs.uk

Locations
United Kingdom
Eastbourne General Hospital Not yet recruiting
Eastbourne, E Sussex, United Kingdom, BN21 2UD
Contact: Conn Sugihara, MBBS    01323 417400 ext 5869    conn.sugihara@esht.nhs.uk   
Principal Investigator: Neil Sulke, MD         
Sub-Investigator: Steve Furniss, MD         
Royal Sussex County Hospital Not yet recruiting
Brighton, East Sussex, United Kingdom, BN2 5BE
Contact: Conn Sugihara, MBBS    01323 417400 ext 5869    conn.sugihara@esht.nhs.uk   
Principal Investigator: Jonathan Hyde, MD         
Sub-Investigator: Michael Lewis, MD         
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 29, 2013
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 April 20, 2014