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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE catheter ablation
  • DEVICE renal artery denervation

Study Locations (1)

New Jersey

  • University of Rochester - Short Hills

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-07-30
Est. Completion 2026-06-30
Phase NA

Sponsor

University of Rochester

636 total trials

What the Registry Record Tells You About NCT05116384

The ClinicalTrials.gov registry entry for NCT05116384 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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