Trial Outcomes & Findings for Rapid Renal Sympathetic Denervation for Resistant Hypertension (NCT NCT01520506)

NCT ID: NCT01520506

Last Updated: 2019-03-01

Results Overview

Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: * SAE's related to groin and vascular access complications, and * SAE's related to renal artery injury.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

One Week

Results posted on

2019-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Rapid Renal Denervation Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries.
Overall Study STARTED	50
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Rapid Renal Denervation Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries.
Overall Study Missed Visit	4
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Rapid Renal Sympathetic Denervation for Resistant Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapid Renal Denervation n=50 Participants Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
Age, Continuous	63.0 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: One Week

Outcome measures

Outcome measures
Measure	Rapid Renal Denervation n=50 Participants Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
Acute Procedural Safety	4 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months

Outcome measures

Outcome measures
Measure	Rapid Renal Denervation n=50 Participants Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
Chronic Procedural Safety	6 percentage of participants

SECONDARY outcome

Timeframe: From baseline to 6 months

Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction \> 10 mmHg at 6 months compared to baseline

Outcome measures

Outcome measures
Measure	Rapid Renal Denervation n=47 Participants Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
Renal Denervation Procedure Effectiveness	61.7 percentage of participants

Adverse Events

Rapid Renal Denervation

Serious events: 16 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rapid Renal Denervation n=50 participants at risk Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
Blood and lymphatic system disorders Blood and lymphatic system disorders	2.0% 1/50 • Number of events 1 • 12 months
Cardiac disorders Cardiac disorders	14.0% 7/50 • Number of events 8 • 12 months
General disorders General disorders and administrative site conditions	2.0% 1/50 • Number of events 1 • 12 months
Infections and infestations Infections and infestations	4.0% 2/50 • Number of events 2 • 12 months
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	2.0% 1/50 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	2.0% 1/50 • Number of events 1 • 12 months
Nervous system disorders Nervous system disorders	2.0% 1/50 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	4.0% 2/50 • Number of events 2 • 12 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	2.0% 1/50 • Number of events 1 • 12 months
Surgical and medical procedures Surgical and medical procedures	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Vascular disorders	6.0% 3/50 • Number of events 4 • 12 months

Other adverse events

Other adverse events
Measure	Rapid Renal Denervation n=50 participants at risk Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
Blood and lymphatic system disorders Blood and lymphatic system disorders	6.0% 3/50 • Number of events 3 • 12 months
Cardiac disorders Cardiac disorders	6.0% 3/50 • Number of events 3 • 12 months
Gastrointestinal disorders Gastrointestinal disorders	6.0% 3/50 • Number of events 3 • 12 months
General disorders General disorders and administrative site conditions	14.0% 7/50 • Number of events 7 • 12 months
Infections and infestations Infections and infestations	2.0% 1/50 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	6.0% 3/50 • Number of events 3 • 12 months
Investigations Investigations	4.0% 2/50 • Number of events 2 • 12 months
Metabolism and nutrition disorders Metabolism and nutrition disorders	4.0% 2/50 • Number of events 2 • 12 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	6.0% 3/50 • Number of events 3 • 12 months
Nervous system disorders Nervous system disorders	14.0% 7/50 • Number of events 7 • 12 months
Psychiatric disorders Psychiatric disorders	4.0% 2/50 • Number of events 2 • 12 months
Renal and urinary disorders Renal and urinary disorders	2.0% 1/50 • Number of events 1 • 12 months
Reproductive system and breast disorders Reproductive system and breast disorders	2.0% 1/50 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	12.0% 6/50 • Number of events 6 • 12 months
Vascular disorders Vascular disorders	4.0% 2/50 • Number of events 2 • 12 months

Additional Information

Stephanie Cihlar

Medtronic

Phone: 763-398-7932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results without permission of the sponsor.
Publication restrictions are in place

Restriction type: OTHER