Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 11:50 AM
Study NCT ID:
NCT02099851
Status:
UNKNOWN
Last Update Posted:
2016-10-17
First Post:
2014-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovascular Carotid Body Ablation in Patients With Treatment- Resistant Hypertension: A Safety and Feasibility Study
Sponsor:
Noblewell
Organization:
Study Overview
Official Title:
Endovascular Carotid Body Ablation in Patients With Treatment- Resistant Hypertension: A Safety and Feasibility Study.
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, observational, multicenter trial to evaluate the safety and feasibility of selective endovascular unilateral carotid body ablation in patients with treatment-resistant hypertension. All patients will be followed for two (2) years following treatment.
Detailed Description:
The investigators propose a new method of treatment, unilateral carotid body ablation, for treatment- resistant hypertensive patients to restore more normal blood pressure control, which will reduce cardiovascular morbidity and mortality in these patients. This strategy will increase the number of therapeutic options available to many patients and their physicians as well as offering the potential of normal blood pressure to those patients in whom blood pressure remains elevated despite vigorous, drug or device based therapies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: