Atrial Fibrillation Clinical Trial
Official title:
Pulmonary Vein Reconnection Following Ablation Index-guided Ablation: a Success Evaluation (PRAISE)
Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart.
Tablets to try to normalise the heart rhythm rarely work well. As a result, doctors have
devised a treatment called catheter ablation in which special wires are used to deliver heat
energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many
patients (almost 1 in 2), some of these ablation lesions recover, and this leads to AF
recurrence. Many of these patients then need a second procedure to deliver further ablation
at these recovered areas.
Recent research has shown that monitoring of heat delivery with a factor called Ablation
Index may be useful in predicting which ablation lesions are less likely to recover.
Therefore, we aim to carry out AF ablation guided with Ablation Index (AI) and observe
whether this will be associated with better durability of ablation lesions, and thereby
better freedom from AF.
This study will include patients with persistent AF, those whose AF episode(s) last for
longer than seven days. All patients participating in the study will undergo an initial
ablation treatment guided by ablation Index . All patients will undergo a repeat procedure
8-10 weeks after their initial treatment. Any gaps found during the second procedure will be
closed again by delivery of ablation.
All participants will be issued with a simple to use handheld heart rhythm monitor, and asked
to make a 30-second recording of their heart rhythm each day and also whenever they have
symptoms. The monitor stores these recordings and they will be downloaded at review
appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation
procedure.
The study is a prospective cohort study in 40 patients with Persistent AF. It will comprise
two groups:
1. Active Group (AI guided ablation): An initial pulmonary vein isolation (PVI) procedure
will be performed guided by AI targets. All patients (regardless of AF recurrence) will
undergo a repeat EP study at 8-10 weeks to identify and re-ablate site(s) of PV
reconnection
2. Historical control group (Contact Force Guided Ablation): will be formed by the 40
patients enrolled to the repeat study arm of the PRESSURE study (ClinicalTrials.gov
Identifier: NCT01942408). All 40 patients underwent contact force-guided PVI followed by
a repeat EP study after 8-10 weeks.
End-points
Primary outcome measure:
The proportion of patients with pulmonary vein (PV) reconnection seen at repeat EP study
Secondary outcome measures:
- The proportion of reconnected PVs seen at repeat electrophysiology (EP) study
- The proportion of patients maintaining freedom from atrial tachyarrhythmia for 12 months
(after an initial 12 week blanking period)
- QOL 6 and 12 months after initial ablation, as quantified by the validated atrial
Fibrillation Effect on QualiTy-of-life (AFEQT) and EQ-5D-5Lquestionnaires.
- Rates of major complications occurring within 60 days after a PVI procedure, measured in
composite numbers and percentage.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |