NCT04657978|UnknownDMC
Substrate Guided Ablation Therapy for Atrial Fibrillation
HEAT-AF
High Density Substrate Evaluation and Guided Ablation Therapy for Atrial Fibrillation
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HEAT-AF
High Density Substrate Evaluation and Guided Ablation Therapy for Atrial Fibrillation
Sponsor study identifier
observational
30
0 countries
N/A
Study Start
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Atrial fibrillation (AF), often referred to as an 'irregular heartbeat', is the most common abnormal heart rhythm worldwide. AF may be intermittent (termed paroxysmal) or sustained (termed persistent).Catheter ablation is increasingly being used to manage individuals with AF, however in a significant proportion of cases AF recurs. Such rhythm control interventions are known to be less effective in individuals with persistent AF compared with those with paroxysmal AF. Analysis of heart tissue of individuals with AF show deposition of scar tissue within the heart muscle and this scar tissue promotes abnormal electrical activity that is involved in causing AF. The aim of the proposed study is to evaluate the feasibility and effectiveness of combining conventional pulmonary vein isolation (PVI) during catheter ablation for AF with adjunctive substrate ablation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2020
Actual (reported)December 8, 2020
Actual (reported)January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Freedom from atrial arrhythmias (>30 seconds) after a single procedure without anti-arrhythmic drugs (AADs) within 12 months, measured by ambulatory holter monitoring
All participants will have an ECG and ambulatory holter monitor performed at 3, 6 and 12 months after the procedure.
12 month
To compare 1-year arrhythmia free clinical outcome with historical control patients matched by propensity score
12 Months
Safety endpoint evaluating the incidence of intraprocedural (primarily Advisor High Density Grid™ mapping catheter) related adverse events
12 Months
To correlate cardiac MRI derived scar distribution and burden in the left atrium with the baseline voltage map obtained using the Advisor High Density Grid™ catheter
12 Months
Participants recruited to the study will undergo High Density Wave Solution™ guided substrate mapping of the left atrium. Ablation will thereafter be performed to comprise wide area circumferential ablation of the pulmonary veins in pairs, followed by ablation of low voltage zones in the left atrium.
Ablation therapy targeting areas of low voltage, which may include encirclement, homogenization or targeting of abnormal electrograms and anchored to a non-conducting structure if the region is in close proximity or likely to create an isthmus for arrhythmias.
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Participants will be recruited from patients with persistent atrial fibrillation who have been referred for catheter ablation based on standard clinical grounds.
Shouvik Haldar, FRCP MD
Royal Brompton and Harefield Hospital
First Submitted
November 27, 2020
First Posted
December 8, 2020
Study Start
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2022
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 8, 2020
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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