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NCT02064764 · ClinicalTrials.gov registry record · NA
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
A NA study, sponsored by Medtronic Vascular.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
NCT02064764: Completed NA study, sponsored by Medtronic Vascular.
NCT02064764 is a NA study that has completed, run by Medtronic Vascular. The registered enrollment target is 102 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02064764, a NA study, has completed, sponsored by Medtronic Vascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.
Primary Outcome
Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the c
Interventions
- DEVICE Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
- DEVICE Arctic Front Advance™ Cardiac Cryoablation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-02 |
| Est. Completion | 2021-04-19 |
| Phase | NA |
What the finished NCT02064764 record still lists
NCT02064764 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter is the first listed.
NCT02064764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02064764 about?
NCT02064764 is a clinical study titled "Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation". The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertensio...
What is the current status of trial NCT02064764?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2015-02. Estimated completion is 2021-04-19.
What interventions are being tested in trial NCT02064764?
The interventions under investigation include: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter (DEVICE), Arctic Front Advance™ Cardiac Cryoablation System (DEVICE).
Who is sponsoring clinical trial NCT02064764?
This trial is sponsored by Medtronic Vascular, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02064764's enrollment target sits among peer trials
102 837th of 2000 higher than 1,161 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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