MedTrace Logo

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

NCT01095770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

AF Ablation with Ablation Frontiers Technology

AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.

PROCEDURE

AF Ablation with LASSO catheter

AF Ablation with traditional LASSO catheter

DEVICE

Reveal XT

Reveal XT implantable loop recorder monitored group

DEVICE

Permanent Dual Chamber Pacemaker

This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.

Sponsors & Collaborators

  • Eastbourne General Hospital

    lead OTHER

Principal Investigators

  • Stephen S Furniss, FRCP, MD · East Sussex NHS Trust

  • AN Sulke, FRCP, MD · East Sussex NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-04-30
Completion
2012-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095770 on ClinicalTrials.gov