NCT01844037

Brief Summary

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

April 29, 2013

Last Update Submit

August 31, 2015

Conditions

HypertensionHeart FailureDiabetes MellitusSleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Change in office systolic blood pressure (SBP) from baseline to 6 months

    6 months

Secondary Outcomes (3)

  • Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.

    One Week

  • Change in office diastolic blood pressure (DBP)

    6 and 12 months post procedure

  • Change in office SBP

    6 and 12 months post procedure

Study Arms (1)

Renal denervation

OTHER

Patients will be treated with the OneShot ablation system

Device: OneShot Ablation System

Interventions

OneShot Ablation SystemDEVICE

Renal denervation

Renal denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
  • Patient is ≥ 18 years old.
  • Patient provided written informed consent.

You may not qualify if:

  • Patients who are pregnant, nursing, or planning to become pregnant.
  • Patients who have only one functioning kidney.
  • Allergy to contrast or known hypersensitivity to device materials
  • Patients with renal arteries \< 4 mm in diameter.
  • Patients whose life expectancy is less than the planned period of study involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

HypertensionHeart FailureDiabetes MellitusSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 1, 2013

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

IT(1)