ClinicalTrials.Veeva

Menu

Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP (LAAPITUP)

E

Eastbourne General Hospital

Status

Unknown

Conditions

Paroxysmal Atrial Fibrillation

Treatments

Device: Permanent Dual Chamber Pacemaker
Device: Reveal XT
Procedure: AF Ablation with Ablation Frontiers Technology
Procedure: AF Ablation with LASSO catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01095770
LAAPITUP

Details and patient eligibility

About

The purpose of this study is 3 fold:-

  1. To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF.
  2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
  3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.

Enrollment

50 estimated patients

Sex

All

Ages

16 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient aged 16-80 years old.
  • Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours.
  • PAF should have failed at least one drug therapy medical therapy.
  • Patients must give written informed consent form prior to participating in this study.

Exclusion criteria

  • Patient is suffering with unstable angina in last 1 week.
  • Patient has had a myocardial infarction within last 2 months.
  • Patient is expecting or has had major cardiac surgery within last 2 months.
  • Patient is participating in a conflicting study.
  • Patient is mentally incapacitated and cannot consent or comply with follow-up.
  • Patient has NYHA class III/ IV heart failure.
  • Patients with severe valvular or ventricular dysfunction.
  • Pregnancy.
  • Patient suffers with other cardiac rhythm disorders.
  • Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 4 patient groups

Ablation Frontiers Ablation
Active Comparator group
Description:
This group will undergo AF ablation using Ablation Frontiers Technology.
Treatment:
Procedure: AF Ablation with Ablation Frontiers Technology
LASSO ablation
Active Comparator group
Description:
This group will undergo atrial fibrillation ablation with traditional LASSO technology
Treatment:
Procedure: AF Ablation with LASSO catheter
Reveal XT monitoring
Active Comparator group
Description:
This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.
Treatment:
Device: Reveal XT
Permanent Pacemaker - dual chamber
Active Comparator group
Description:
This group will be monitored pre and post ablation with a dual chamber permanent pacemaker
Treatment:
Device: Permanent Dual Chamber Pacemaker

Trial contacts and locations

1

Loading...

Central trial contact

Steven J Podd, MBBS, MRCP, BA

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems