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Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes. Abnormal electrical activity from the pulmonary veins are thought to be the most common cause of this condition. Current ablative strategy in drug refractory AF is pulmonary vein isolation (PVI), where the pulmonary veins are electrically isolated from the body of the left atrium. However, success rate of this procedure remain ~50-70% for a single procedure despite advances in mapping and ablation techniques.
Ganglionated plexuses (GP) are dense clusters of nerves in the atria that are implicated in AF. Endocardial high frequency stimulation (HFS) delivered within the local atrial refractory period can trigger ectopy and AF from specific GP sites (ET-GP). The aim of this study was to understand the role of ET-GP ablation in the treatment of AF by comparing two different strategies:
This is a prospective, multi-centre study recruiting patients with paroxysmal AF indicated for AF ablation.
180 patients will be recruited. Patients are randomised to either GP ablation alone or to PVI. All antiarrhythmics are stopped for at least 48 hours prior to their procedures.
All have general anaesthesia and CARTO system (Biosense Webster, inc.) are used for 3D electroanatomical mapping of the left atrium.
Patients randomised to GP ablation will have high frequency mapping performed within the atrial refractory period to identify ectopy or AF triggering GP (ET-GP) sites in the left atrium. Patients in this group will only have GP ablation and will not have pulmonary veins isolated.
The primary endpoint is any documented atrial arrhythmia 30 seconds or more after a 3 month blanking period. This will be assessed for up to 12 months post-procedure, using 48hr Holter monitors at 3, 6, 9 and 12 month intervals.
Secondary endpoints include mortality, major complications and redo procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary vein isolation | Active Comparator | Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. |
|
| Ganglionated plexus ablation | Experimental | Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation | Procedure | Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure | That is documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months; the outcome measure will be assessed up to 12 months of follow-up with 48hr halter monitors arranged every 3 months to investigate Arrhythmia recurrence . | 3 to 12 months post-ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Presenting a Reduction in the Usage of Antiarrhythmics Post-ablation | The reduction was defined as either a decrease of dose or a cessation of a drug over a 12 month follow-up period post ablation. | 3 to 12 months post-ablation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prapa Kanagaratnam, PhD | Imperial College NHS Healthcare Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | W12 0HS | United Kingdom | |||
| St Bartholomew's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34915187 | Derived | Kim MY, Coyle C, Tomlinson DR, Sikkel MB, Sohaib A, Luther V, Leong KM, Malcolme-Lawes L, Low B, Sandler B, Lim E, Todd M, Fudge M, Wright IJ, Koa-Wing M, Ng FS, Qureshi NA, Whinnett ZI, Peters NS, Newcomb D, Wood C, Dhillon G, Hunter RJ, Lim PB, Linton NWF, Kanagaratnam P. Ectopy-triggering ganglionated plexuses ablation to prevent atrial fibrillation: GANGLIA-AF study. Heart Rhythm. 2022 Apr;19(4):516-524. doi: 10.1016/j.hrthm.2021.12.010. Epub 2021 Dec 13. |
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The enrolement of participants was between 2017 and 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Vein Isolation | Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. |
| FG001 | Ganglionated Plexus Ablation | Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Vein Isolation | Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. |
| BG001 | Ganglionated Plexus Ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure | That is documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months; the outcome measure will be assessed up to 12 months of follow-up with 48hr halter monitors arranged every 3 months to investigate Arrhythmia recurrence . | Number of patients with no evidence of Atrial arrhythmia recurrence, >30s, on a 48 hour Holter monitor during the initial 12 months post procedure | Posted | Count of Participants | Participants | 3 to 12 months post-ablation. |
|
12 months post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulmonary Vein Isolation | Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. Pulmonary vein isolation: Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | Systematic Assessment | Pericardiocentesis performed which successfully treated cardiac tamponade. No other complications, discharged following day of ablation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | Systematic Assessment | Hospital attendance with symptoms consistent with pericarditis, conservatively managed with short course of analgesia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Prapa Kanagaratnam | Imperial College London | +44 20 3313 1000 | p.kanagaratnam@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2021 | Sep 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Ganglionated plexus ablation | Procedure | Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium |
|
|
| London |
| United Kingdom |
| Derriford Hospital | Plymouth | United Kingdom |
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Ganglionated Plexus Ablation | Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium |
|
|
|
| Secondary | Number of Participants Presenting a Reduction in the Usage of Antiarrhythmics Post-ablation | The reduction was defined as either a decrease of dose or a cessation of a drug over a 12 month follow-up period post ablation. | Posted | Count of Participants | Participants | 3 to 12 months post-ablation. |
|
|
|
| Post-Hoc | Extended Follow up to Assess Freedom From Atrial Arrhythmia Over a Prolonged Duration | evidence of >30s atrial arrhythmia or symptoms consistent with arrhythmia recurrence, during routine clinical care, over an extended follow up period of 40 months. | Not Posted | Dec 2024 | 40 months post procedure. | Participants |
| 0 |
| 53 |
| 0 |
| 53 |
| 1 |
| 53 |
| EG001 | Ganglionated Plexus Ablation | Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium Ganglionated plexus ablation: Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium | 0 | 63 | 1 | 63 | 7 | 63 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |