Atrial Fibrillation Clinical Trial
— HD-WACAOfficial title:
Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation
NCT number | NCT02917044 |
Other study ID # | 15HH2466 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | June 2018 |
Verified date | October 2019 |
Source | Imperial College Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, multicentre, randomized single blind, parallel group study to be conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40 eligible for randomization. The study is designed to compare the operator's best attempt at WACA completion with and without Rhythmia guidance
Status | Terminated |
Enrollment | 17 |
Est. completion date | June 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - ECG documented AF - Listed for AF ablation by referring physician - Planned ablation includes a first-time PVI. - Patient signed informed consent form Exclusion Criteria: - Age <18 or >80 - LA diameter >60mm - AF secondary to transient correctible abnormalits (e.g. electrolyte imbalance, thyrotoxicosis, recent infective or inflammatory process) - Intra-atrial thrombus or tumour - Renal failure requiring haemodialysis - Heart failure with NYHA III-IV or EF<35% |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hammersmith Hospital | London | Please Select Region, State Or Province |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust | Boston Scientific Corporation |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total time in minutes required to produce isolation of veins per WACA | Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total RF time taken to isolate the veins for that WACA will be measured as one of 2 joint primary outcome measures. | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Primary | Total number of radiofrequency ablation lesions to produce isolation of veins per WACA | Following first pass ablation with WACA, if either vein is not isolated the patient will be randomized into group A or B. The total number of lesions (each lesion being 30s in duration) to isolate the veins for that WACA will be measured as one of two joint primary outcome measures. | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Secondary | Whether ostial ablation is required in each case (Yes/No) | This is a measure of whether ostial ablation (undesirable) will be required (yes/no). It is assessed during procedure. | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Secondary | Number of radiofrequency ablation lesions required within the WACA lesion set | The number of oostial lesions required in each case (number of ablation lesions) | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Secondary | Total radiofrequency ablation time (in mins) within the WACA lesion set | This is the total ablation time (in mins) within the WACA required to produce PV isolation | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Secondary | Total number of radiofrequency ablation lesions required to produce PV isolation per patient | As per primary endpoint but on a per patient rather than per vein basis | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Secondary | Total procedural time (in mins) required to produce PV isolation | Whether procedure time (in mins) is different in group A vs group B | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Secondary | Percentage of patients with successful PV isolation | Proportion of veins successfully isolated with the contrasting techniques | Procedural - i.e. assessed over procedure duration only (about 3 hours) | |
Secondary | Percentage of patients suffering symptomatic PV stenosis | Proportion of patients coming back within 3 months with symptomatic PV stenosis | 3 months | |
Secondary | Percentage of patients with AF recurrence | Proportion of patients remaining AF free at 3 months as analysed per Kaplan-Meier format | 3 months |
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