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NCT01747837 · ClinicalTrials.gov registry record · NA
REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
A NA study of Ventricular Tachycardia, sponsored by Vivek Reddy.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 4
- Study locations
NCT01747837: Completed NA study of Ventricular Tachycardia, sponsored by Vivek Reddy.
NCT01747837 is a NA study of Ventricular Tachycardia that has completed, run by Vivek Reddy. The registered enrollment target is 48 participants, below the 287-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01747837, a NA study of Ventricular Tachycardia, has completed, sponsored by Vivek Reddy.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 4
- Study locations
Study Summary
The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii) primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular stimulation at the time of ICD implantation. These patients will be randomized to ICD alone or ICD + RSDN.
Primary Outcome
The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.
Conditions Studied
Interventions
- DEVICE Boston Scientific Vessix Renal Denervation System
Study Locations (4)
Other
- Na Homolce Hospital - Prague
- Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology - Novosibirsk
New York
- Mount Sinai Hospital - New York
Texas
- Texas Cardiac - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-10-22 |
| Est. Completion | 2019-01-09 |
| Phase | NA |
What the finished NCT01747837 record still lists
NCT01747837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 287-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Ventricular Tachycardia appearing as the primary indexed condition, and to 1 intervention - of which Boston Scientific Vessix Renal Denervation System is the first listed.
NCT01747837 reports a single indexed study location in Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT01747837 about?
NCT01747837 is a clinical study titled "REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients". The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receiv...
What is the current status of trial NCT01747837?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2015-10-22. Estimated completion is 2019-01-09.
What conditions does trial NCT01747837 study?
This clinical trial studies the following conditions: Ventricular Tachycardia.
What interventions are being tested in trial NCT01747837?
The interventions under investigation include: Boston Scientific Vessix Renal Denervation System (DEVICE).
Who is sponsoring clinical trial NCT01747837?
This trial is sponsored by Vivek Reddy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01747837 being conducted?
This trial has 4 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01747837's enrollment target sits among peer trials
48 21st of 28 higher than 8 of 28 other Ventricular Tachycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ventricular Tachycardia 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.
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