Persistent Atrial Fibrillation Ablation Trial

Atrial Fibrillation Clinical Trial

— PAAT  

Official title:

Persistent Atrial Fibrillation Ablation Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01891825
• Other study ID #: PAAT
• Status: Suspended
• Phase: N/A
• First received: June 29, 2013
• Last updated: June 25, 2014
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2014
• Source: Eastbourne General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Surgical AF ablation
Minimally invasive thoracoscopic surgical ablation of atrial fibrillation
• Percutaneous AF ablation
Percutaneous catheter ablation of atrial fibrillation

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton	East Sussex
United Kingdom	Eastbourne General Hospital	Eastbourne	E Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Neil Sulke

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life changes after AF ablation		12 months	No
Other	Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation		12 months	No
Other	Change in echocardiographic left atrial dimensions and function after AF ablation		12 months	No
Other	Change in cognitive function as assessed by the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) instruments		12 months	No
Primary	Recurrence of persistent AF by 12 months after ablation	Mean time to recurrence of persistent AF after ablation	12 months	No
Secondary	Change in AF burden after AF ablation	Detected by ILR	12 months	No
Secondary	Time to first episode of symptomatic AF after ablation	Time to first episode of symptomatic AF after ablation	12 months	No
Secondary	Time to first episode of any AF after ablation	As detected by ILR	12 months	No
Secondary	Total number of AF episodes after AF ablation	As detected by ILR, outside blanking period	12 months	No
Secondary	Total number of AF episodes lasting greater than 6 minutes after AF ablation	As detected by ILR, outside blanking period	12 months	No
Secondary	New MRI-detected subclinical cerebral embolic events		3 months	No