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Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Neil Sulke, Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01504451
First received: December 30, 2011
Last updated: June 25, 2014
Last verified: June 2014

December 30, 2011
June 25, 2014
April 2012
April 2015   (final data collection date for primary outcome measure)
AF burden [ Time Frame: 12 months after ablation ] [ Designated as safety issue: No ]
Total proportion of time spent in AF as assessed by ILR
Same as current
Complete list of historical versions of study NCT01504451 on ClinicalTrials.gov Archive Site
  • Time to AF recurrence [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Time to recurrence of any AF after ablation
  • Time to first symptomatic AF recurrence [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Time to first symptomatic AF recurrence as assessed by ILR.
  • Change in QoL measures [ Time Frame: 12 months after ablation ] [ Designated as safety issue: No ]
    Change in Quality of Life measures assessed by questionnaire.
Same as current
Not Provided
Not Provided
 
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2

This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.

A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
  • Device: ILR insertion
    Insertion of implantable loop recorder
  • Procedure: AF ablation
    AF ablation
  • Active Comparator: Biosense Webster ablation
    Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
    Interventions:
    • Device: ILR insertion
    • Procedure: AF ablation
  • Active Comparator: Surgical ablation
    Minimally invasive thoracoscopic surgical AF ablation
    Interventions:
    • Device: ILR insertion
    • Procedure: AF ablation
  • Active Comparator: Medtronic ablation
    Medtronic multi-electrode phased radiofrequency AF ablation
    Interventions:
    • Device: ILR insertion
    • Procedure: AF ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
May 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic paroxysmal AF suitable for AF ablation
  • Age > 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01504451
LAAPITUP 2
Yes
Neil Sulke, Eastbourne General Hospital
Neil Sulke
Not Provided
Principal Investigator: Neil Sulke, MD Eastbourne General Hospital
Principal Investigator: Stephen S Furniss, MD Eastbourne General Hospital
Eastbourne General Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP