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
  Purpose

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.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Device: ILR insertion
Procedure: AF ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2

Resource links provided by NLM:


Further study details as provided by Eastbourne General Hospital:

Primary Outcome Measures:
  • AF burden [ Time Frame: 12 months after ablation ] [ Designated as safety issue: No ]
    Total proportion of time spent in AF as assessed by ILR


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 75
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biosense Webster ablation
Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
Device: ILR insertion
Insertion of implantable loop recorder
Procedure: AF ablation
AF ablation
Active Comparator: Surgical ablation
Minimally invasive thoracoscopic surgical AF ablation
Device: ILR insertion
Insertion of implantable loop recorder
Procedure: AF ablation
AF ablation
Active Comparator: Medtronic ablation
Medtronic multi-electrode phased radiofrequency AF ablation
Device: ILR insertion
Insertion of implantable loop recorder
Procedure: AF ablation
AF ablation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01504451

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

No publications provided

Responsible Party: Neil Sulke, Consultant Cardiologist, Eastbourne General Hospital
ClinicalTrials.gov Identifier: NCT01504451     History of Changes
Other Study ID Numbers: LAAPITUP 2
Study First Received: December 30, 2011
Last Updated: June 25, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Eastbourne General Hospital:
Atrial fibrillation
Ablation
Implantable loop recorder

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

ClinicalTrials.gov processed this record on September 15, 2014