Catheter Versus Thoracoscopic Surgical Ablation Strategy in Persistent Atrial Fibrillation
NCT ID: NCT01385358
Last Updated: 2011-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2011-04-30
2013-10-31
Brief Summary
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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
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Thoracoscopically Assisted Surgical Ablation
This arm will have an index thoracoscopically assisted surgical ablation.
Thoracoscopically Assisted Surgical Ablation
Surgical AF ablation including pulmonary vein isolation, gananglionated plexi ablation +/- LAA excision/exclusion.
Catheter Ablation
This is an active comparator arm where study subjects will undergo conventional catheter ablation.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
Yes
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Royal Brompton & Harefield NHS Foundation Trust
Principal Investigators
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Tom Wong, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Locations
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Royal Brompton & Harefield NHS Foundation Trust
London, Greater London, United Kingdom
Countries
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Other Identifiers
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11/SC/0032
Identifier Type: OTHER
Identifier Source: secondary_id
2011CI004B
Identifier Type: -
Identifier Source: org_study_id