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NCT02918396 · ClinicalTrials.gov registry record · NA
The Substrate and Intervention Mechanisms for Persistent Atrial Fibrillation Trial
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT02918396: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT02918396 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02918396, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with increasing morbidity and mortality. A catheter-based AF ablation technique that isolates pulmonary veins (PV) from the left atrium has been established to disrupt AF. Despite significant development, AF ablation with pulmonary vein isolation (PVI) is reported to have a success rate of 40-80% in various AF populations. Persistent AF appears to be more reliant upon fibroblast proliferation and myocyte-fibroblast coupling than paroxysmal AF with obvious implications on its management. Despite the knowledge that fibrotic substrate is responsible for the perpetuation of persistent AF, several ablation techniques targeting these extra-pulmonary veins sites have failed to prove an additional benefit to PVI alone. Nevertheless, two recently developed technologies, aimed at detecting AF substrate with high precision, seem to constitute a potential breakthrough in the management of persistent AF. On one hand, late gadolinium-enhanced MRI (LGE-MRI) is a well-established method to identify fibrosis in the myocardium. Recent reports from a single center have shown that MRI-based left atrial fibrosis detection is able to predict the outcome of the procedure. Hence, targeting lesions seen on LGE-MRI in the setting of persistent AF is an option yet to be explored and compared to the widely adopted, yet suboptimal, PVI. On another hand, a novel ablation method with promising results is focal impulse and rotor modulation (FIRM). Undergoing wide sampling of the atria with spatiotemporal and computational mapping while in AF has identified areas with stable organized rotational electrical activity (rotors). Several studies are under way to prove the reproducibility of rotor mapping, with more groups reporting improved rates of acute and long-term suppression of AF with ablation of FIRM-identified rotors. The SIMPle AF study will be a randomized clinical trial designed to test the hypothesis that ablation ta
Interventions
- DEVICE Scar-Based Radio-frequency Ablation
- DEVICE Rotor Anchors Radio-frequency Ablation
- DEVICE Conventional PVI by Radio-frequency Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02918396
The ClinicalTrials.gov registry entry for NCT02918396 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Scar-Based Radio-frequency Ablation is the first listed.
NCT02918396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02918396 about?
NCT02918396 is a clinical study titled "The Substrate and Intervention Mechanisms for Persistent Atrial Fibrillation Trial". Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with increasing morbidity and mortality. A catheter-based AF ablation technique that isolates pulmonary veins (PV) from the left atrium has been established to disrupt AF. Despite significant development, AF ablation with pulmo...
What is the current status of trial NCT02918396?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2016-04. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02918396?
The interventions under investigation include: Scar-Based Radio-frequency Ablation (DEVICE), Rotor Anchors Radio-frequency Ablation (DEVICE), Conventional PVI by Radio-frequency Ablation (DEVICE).
Who is sponsoring clinical trial NCT02918396?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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