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A streamlined AF ablation procedure done without PV mapping as a daycase is more effective than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial fibrillation.
AVATAR-AF is a multicentre, randomised controlled study comparing a streamlined AVATAR-protocol ablation procedure to anti-arrhythmic therapy in patients with documented paroxysmal AF who are considered to be failing current strategy for AF. A secondary control arm will also compare the AVATAR-protocol to conventional AF ablation. 300 patients who are on no prior anti-arrhythmic, 'pill-in-pocket' or taking regular anti-arrhythmics will be randomised in a 1:1:1 manner to a treatment strategy of either AVATAR-protocol ablation, anti-arrhythmic therapy or conventional AF ablation and followed-up for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 3-Conventional AF Ablation | Active Comparator | This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition. |
|
| Group 2-Anti-arrhythmic therapy | Active Comparator | Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used. |
|
| Group 1-AVATAR-AF Ablation Protocol | Experimental | AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVATAR-AF ablation | Procedure | Experimental ablation protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia | Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Death or Stroke From Any Cause | Composite outcome measure | 12 months |
| Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Prapa Kanagaratnam | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Bournemouth Hospital | Bournemouth | BH4 7DW | United Kingdom | |||
| Brighton University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36576323 | Result | Kanagaratnam P, McCready J, Tayebjee M, Shepherd E, Sasikaran T, Todd D, Johnson N, Kyriacou A, Hayat S, Hobson NA, Mann I, Balasubramaniam R, Whinnett Z, Earley M, Petkar S, Veasey R, Kirubakaran S, Coyle C, Kim MY, Lim PB, O'Neill J, Davies DW, Peters NS, Babalis D, Linton N, Falaschetti E, Tanner M, Shah J, Poulter N. Ablation versus anti-arrhythmic therapy for reducing all hospital episodes from recurrent atrial fibrillation: a prospective, randomized, multi-centre, open label trial. Europace. 2023 Mar 30;25(3):863-872. doi: 10.1093/europace/euac253. | |
| 31152874 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 3-Conventional AF Ablation | This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition. Conventional AF ablation: Conventional ablation procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2018 | Aug 24, 2022 |
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| Anti-Arrhythmic therapy | Drug | Group 2 will be prescribed medication listed below: Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone. You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed. |
|
|
| Conventional AF ablation | Procedure | Conventional ablation procedure |
|
|
Composite outcome measure - Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other) |
| 12 months |
| All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia | Composite outcome measure - All hospital episodes which result in a change in therapy for atrial arrhythmia | 12 months |
| Brighton |
| BN2 1ES |
| United Kingdom |
| Coventry University Hospital | Coventry | CV2 1EP | United Kingdom |
| Eastbourne District General Hospital | Eastbourne | United Kingdom |
| Castle Hill Hospital | Hull | HU16 5JQ | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| Liverpool Heart and Chest Hospital | Liverpool | L14 3PE | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Hammersmith Hospital | London | W12 0NN | United Kingdom |
| Freeman Hospital | Newcastle | NE7 7DN | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
| Sheffield University Hospital | Sheffield | S5 7AU | United Kingdom |
| New Cross Hospital | Wolverhampton | United Kingdom |
| Derived |
| Mann I, Sasikaran T, Sandler B, Babalis D, Johnson N, Falaschetti E, Copley A, Tayebjee M, Todd D, Shepherd E, McCready J, Poulter N F, Kanagaratnam P. Ablation versus Anti-Arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent Atrial Fibrillation (AVATAR-AF): Design and rationale. Am Heart J. 2019 Aug;214:36-45. doi: 10.1016/j.ahj.2019.04.015. Epub 2019 May 3. |
| FG001 | Group 2-Anti-arrhythmic Therapy | Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used. Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below: Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone. You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed. |
| FG002 | Group 1-AVATAR-AF Ablation Protocol | AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic. AVATAR-AF ablation: Experimental ablation protocol |
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT analysis population (all randomised)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 3-Conventional AF Ablation | This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition. Conventional AF ablation: Conventional ablation procedure |
| BG001 | Group 2-Anti-arrhythmic Therapy | Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used. Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below: Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone. You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed. |
| BG002 | Group 1-AVATAR-AF Ablation Protocol | AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic. AVATAR-AF ablation: Experimental ablation protocol |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| BMI (Body Mass Index) | Missing BMI data for 4nr participants | Mean | Standard Deviation | kg/m^2 |
| |||||||||
| No. with Hypertension | Count of Participants | Participants |
| |||||||||||
| CHADSVASc Score (congestive heart failure, hypertension) | The CHADSVASc scoring system assigns 1 point for ages 65-74, 2 points for age ≥75, 1 point for female sex, 1 point for congestive heart failure, 1 point for hypertension, 2 points for history of stroke, transient ischemic attack, or history of thromboembolism, 1 point for vascular disease, and 1 point for Diabetes mellitus. The score ranges from 0 to 9 points, and patients are categorized as low risk (score 0), medium risk (score 1), or high risk (score 2 or higher). | The full name for CHADSVASc is Congestive Heart Failure, Hypertension, Age ≥75 (Doubled), Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack (Doubled), Vascular Disease, Age 65-74, Sex category. CHADSVASc missing for 3nr participants | Count of Participants | Participants |
| |||||||||
| Ejection Fraction | 44 participants EJF missing at BL | Mean | Standard Deviation | % |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia | Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia | All randomized participants are eligible for ITT analysis - however, any patients that withdraw prior to first intervention cannot be assessed for the time-to-event based analysis | Posted | Count of Participants | Participants | 12 months |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death or Stroke From Any Cause | Composite outcome measure | Full ITT Population | Posted | Count of Participants | Participants | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other) | Composite outcome measure - Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other) | ITT Population | Posted | Number | participants | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia | Composite outcome measure - All hospital episodes which result in a change in therapy for atrial arrhythmia | Not Posted | 12 months | Participants |
AE's are collected from Randomization up to 1-year end-of-Study Visit
All SAE's were reviewed by an independent Data Monitoring and Safety Board (DSMB)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 3-Conventional AF Ablation | This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition. Conventional AF ablation: Conventional ablation procedure | 0 | 108 | 16 | 108 | 43 | 108 |
| EG001 | Group 2-Anti-arrhythmic Therapy | Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used. Anti-Arrhythmic therapy: Group 2 will be prescribed medication listed below: Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone. You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed. | 1 | 103 | 12 | 103 | 50 | 103 |
| EG002 | Group 1-AVATAR-AF Ablation Protocol | AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic. AVATAR-AF ablation: Experimental ablation protocol | 0 | 110 | 13 | 110 | 57 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation/Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Mass In Left Atrium | Cardiac disorders | Systematic Assessment |
| ||
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Bilateral Papilledema. | Eye disorders | Systematic Assessment |
| ||
| Palpitation | Cardiac disorders | Systematic Assessment |
| ||
| Right Arm And Face Numbness | Nervous system disorders | Systematic Assessment |
| ||
| Injury To Right Hand | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pneumonia & Bronchospasm. | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Vascular disorders | Systematic Assessment |
| ||
| Nose Surgery | Investigations | Systematic Assessment |
| ||
| Bleeding From Groin | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pelvic Floor Repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fractured Ribs, Cuts And Bruises. | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Strand Of Likely Thrombus Attached To Septum | Cardiac disorders | Systematic Assessment |
| ||
| Hip Replacement. | Surgical and medical procedures | Systematic Assessment |
| ||
| Femoral Entry Wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Systematic Assessment |
| ||
| Knee Replacement | Surgical and medical procedures | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| TIA | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Non-systematic Assessment |
| ||
| All other events < 5% Freq | Investigations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Prapa Kanagaratnam | Imperial College London | 02033123783 | p.kanagaratnam@imperial.ac.uk |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2018 | Aug 24, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D013015 | Sotalol |
| D000319 | Adrenergic beta-Antagonists |
| D002121 | Calcium Channel Blockers |
| D005424 | Flecainide |
| D011405 | Propafenone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D049990 | Membrane Transport Modulators |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011427 | Propiophenones |
| D007659 | Ketones |
Not provided
Not provided
|
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Secondary analysis of Primary Outcome measure - AVATAR-AF vs Conventional Ablation |
| Log Rank |
| 0.6061 |
Bonferonni corrected alpha 0.05/2 = 0.025 |
| Hazard Ratio (HR) |
| 1.173 |
| 2-Sided |
| 95 |
| 0.639 |
| 2.154 |
95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Conventional Ablation |
| Superiority |
| OG002 | Group 1-AVATAR-AF Ablation Protocol | AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic. AVATAR-AF ablation: Experimental ablation protocol |
|
|
| OG002 | Group 1-AVATAR-AF Ablation Protocol | AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic. AVATAR-AF ablation: Experimental ablation protocol |
|
|