Catheter Versus Thoracoscopic Surgical Ablation Strategy in Persistent Atrial Fibrillation

NCT01385358 | Unknown

• 2 other identifiers: 2011CI004B11/SC/0032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial tachyarrhythmias at 12 months.

  Freedom from atrial tachyarrhythmias at 12 months which will be analysed with or without anti-arrhythmic drugs (AAD). Monitoring will be undertaken with ambulatory ECG monitoring in compliance with latest international guidelines.

  12 months

Secondary Outcomes (5)

• Freedom from atrial tachyarrhythmias at 12 months from a single procedure on/off AAD;

  12 months

• Change in AF symptom score

  Various time points 0,3,6,9,12 months

• Integrity of ablation lesion after index procedure at 3 months (as assessed by MRI if in SR +/- electrophysiologically if redo procedure is undertaken for atrial arrhythmia recurrence);

  3 months

• Freedom of serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up.

  12 months

• Cost analysis (procedural and hospital stay costs).

  12 months

Study Arms (2)

Thoracoscopically Assisted Surgical Ablation

EXPERIMENTAL

This arm will have an index thoracoscopically assisted surgical ablation.

Procedure: Thoracoscopically Assisted Surgical Ablation

Catheter Ablation

ACTIVE COMPARATOR

This is an active comparator arm where study subjects will undergo conventional catheter ablation.

Procedure: Catheter Ablation

Interventions

Thoracoscopically Assisted Surgical Ablation PROCEDURE

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

Thoracoscopically Assisted Surgical Ablation

Catheter Ablation PROCEDURE

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.

Catheter Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤ 80
• Symptomatic persistent AF (≥1≤5 years), refractory to at least 1 AAD and/or DCCV
• Patient is legally competent and willing and able to sign informed consent form
• Patient is willing and able to adhere to follow up visit protocols for the duration of the study

You may not qualify if:

• Left ventricular ejection fraction \< 40%
• Cardiovascular implantable electronic device (contraindicates MRI imaging)
• Contraindication to anticoagulation
• Thrombus in the LA despite anticoagulation
• CVA within the previous 6 months
• Previous thoracic \& cardiac surgery (including interventions for AF such as Cox-maze procedure)
• Prior LA catheter ablation with the intention to treat AF
• Prior AV nodal ablation
• Patients actively participating in another research study will be not be permitted to enrol. Patients who have been involved with other research studies will be able to participate after a minimum period of 3 months after completion of prior study follow up.
• Co-morbid condition that in opinion of investigator confers undue risk of GA or thoracoscopic surgery.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefield NHS Foundation Trust

London, Greater London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Tom Wong, MD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 30, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 30, 2011

Record last verified: 2011-06

Locations

GB (1)