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NCT05116384 · ClinicalTrials.gov registry record · NA
Renal Denervation + PVI vs PVI Alone for Persistent AF
A NA study of Atrial Fibrillation, sponsored by University of Rochester.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05116384: Recruiting NA study of Atrial Fibrillation, sponsored by University of Rochester.
NCT05116384 is a NA study of Atrial Fibrillation that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 50 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05116384, a NA study of Atrial Fibrillation, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives. This is a randomized controlled pilot trial, "To Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II) to test if RDN plus PVI enhances long-term efficacy vs PVI for persistent AF patients with controlled or without hypertension using implantable loop recordings.
Primary Outcome
The calculated total amount of time in AF after 3-month blanking period
Conditions Studied
Interventions
- DEVICE catheter ablation
- DEVICE renal artery denervation
Study Locations (1)
New Jersey
- University of Rochester - Short Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-07-30 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT05116384 shows while recruiting
NCT05116384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which catheter ablation is the first listed.
NCT05116384 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05116384 about?
NCT05116384 is a clinical study titled "Renal Denervation + PVI vs PVI Alone for Persistent AF". Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrate...
What is the current status of trial NCT05116384?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-07-30. Estimated completion is 2026-06-30.
What conditions does trial NCT05116384 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT05116384?
The interventions under investigation include: catheter ablation (DEVICE), renal artery denervation (DEVICE).
Who is sponsoring clinical trial NCT05116384?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05116384 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05116384's enrollment target sits among peer trials
50 174th of 202 higher than 25 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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