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Catheter Versus Thoracoscopic Surgical Ablation Strategy in Persistent Atrial Fibrillation

NCT01385358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-06-30

No results posted yet for this study

Summary

Atrial fibrillation(AF)is the commonest arrhythmia worldwide and can lead to significant morbidity and mortality, posing an increasing public health burden. Restoration of sinus rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with anti-arrhythmic drugs (AAD) are poor. The alternatives to AAD are two-fold.Firstly, catheter ablation (CA)- a technique that uses catheters (thin tubes) to deliver small 'heat lesions' to areas of the heart to eliminate AF. Secondly, surgical ablation, where multiple incisions are made in the atria to restore SR. Long term results from this traditional surgical approach are excellent however as it is technically difficult open-heart procedure with significant morbidity and mortality, it is seldom used.

CA is very effective in restoring SR in the early stages of AF when it is a paroxysmal (intermittent) rhythm disturbance. If not treated at this stage AF inevitably evolves into a more persistent or permanent state and becomes more difficult to treat with CA. Therefore, the optimum approach to treat patients with symptomatic long standing persistent AF has yet to be determined and remains a key area of on-going research.

New minimally invasive, thoracoscopically assisted surgical(closed-heart)approaches have recently developed which ablate a wide area around the pulmonary veins, and may offer advantages over the best current strategies in CA. There are also clear advantages for patients with greater safety and less discomfort when compared to traditional surgical open-heart procedures.

At present there is small amount of encouraging data on this thoracoscopic surgical technique but there is no data comparing these two modalities of treatment in persistent AF patients. The investigators therefore wish to prospectively investigate the safety and efficacy of this thoracoscopic surgical technique and compare with CA in this group of patients. MRI scanning will also be used to visualise the effects of ablation by analysis of scar formation.

The study hypothesises that thoracoscopics surgical ablation is a

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

Thoracoscopically Assisted Surgical Ablation

Surgical AF ablation including pulmonary vein isolation, gananglionated plexi ablation +/- LAA excision/exclusion.

PROCEDURE

Catheter Ablation

In this arm, study subjects will undergo conventional catheter ablation as their index procedure. This will include pulmonary vein isolation, linear and electrogram based ablation.

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Tom Wong, MD · Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT01385358 on ClinicalTrials.gov