Catheter Versus Thoracoscopic Surgical Ablation Strategy in Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— CASA-AF  

Official title:

A Study to Assess Catheter Ablation Versus Thoracoscopically Assisted Surgical Ablation in Persistent Atrial Fibrillation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01385358
• Other study ID #: 2011CI004B
• Secondary ID: 11/SC/0032
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 28, 2011
• Last updated: June 29, 2011
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: June 2011
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Royal Brompton & Harefield NHS Foundation Trust
• Study type: Interventional

Clinical Trial 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

Description:

This will be a pilot, prospective, observational study of catheter ablation compared with thoracoscopically assisted, surgical ablation strategies using a case control design.

The study population will be patients between the ages of 18 and 80 with symptomatic long-standing persistent atrial fibrillation (≥1≤5 years) and good left ventricular function where at least one anti-arrhythmic drug (AAD) has failed, or where such drugs are contraindicated or not tolerated.

Thoracoscopically Assisted Surgical Ablation Group Patients assigned to this group will undergo minimally invasive, thoracoscopically assisted, surgical ablation to isolate the pulmonary veins (PVI) using a radiofrequency (RF) clamp device. This will include ganglionated plexi ablation +/- LAA excision/exclusion.

Catheter Ablation Group Patients will undergo pulmonary vein isolation, linear and electrogram based ablation.

Recurrences Only one redo procedure is allowed for atrial tachyarrhythmia recurrences in the 12 month follow-up period.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age =18 years and = 80

2. Symptomatic persistent AF (=1=5 years), refractory to at least 1 AAD and/or DCCV

3. Patient is legally competent and willing and able to sign informed consent form

4. Patient is willing and able to adhere to follow up visit protocols for the duration of the study

Exclusion Criteria:

1. Left ventricular ejection fraction < 40%

2. Cardiovascular implantable electronic device (contraindicates MRI imaging)

3. Contraindication to anticoagulation

4. Thrombus in the LA despite anticoagulation

5. CVA within the previous 6 months

6. Previous thoracic & cardiac surgery (including interventions for AF such as Cox-maze procedure)

7. Prior LA catheter ablation with the intention to treat AF

8. Prior AV nodal ablation

9. 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.

10. Co-morbid condition that in opinion of investigator confers undue risk of GA or thoracoscopic surgery.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Thoracoscopically Assisted Surgical Ablation
Surgical AF ablation including pulmonary vein isolation, gananglionated plexi ablation +/- LAA excision/exclusion.
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Freedom from atrial tachyarrhythmias at 12 months from a single procedure on/off AAD;	Only 1 re-do procedure is allowed in study time frame. But this outcome will look at single procedure success in both arms at 12 months.	12 months	No
Secondary	Change in AF symptom score	Using recognised AF symptom score scale	Various time points 0,3,6,9,12 months	No
Secondary	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);	Using MRI +/- electrophysiological techniques.	3 months	No
Secondary	Freedom of serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up.		12 months	Yes
Secondary	Cost analysis (procedural and hospital stay costs).	Top down cost analysis	12 months	No