Clinical trials: sponsored by Medtronic
Hypertension, Vascular Diseases
Spyral InSight Study
The purpose of the Spyral InSight Early Clinical Feasibility Study is to characterize the physiological response to renal nerve stimulation (RNS) in humans prior to and post renal denervation.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- Spyral InSight (NCT07013929)
- Testing
- Renal nerve stimulation
- Where
- 2 sites in Greece, Ireland
- Volunteers
- 19 people
- Sponsor
- Medtronic Vascular
Oxygen Saturation
Nellcor™ Investigational Device Sitting-Walking Study
To examine pulse rate and blood oxygen saturation accuracy of the Nellcor™ Investigational Device during non-motion and walking motion conditions in a diverse patient population through non-invasive means
- Trial name
- NCT07234279
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Atrial Fibrillation (AF), Persistent Atrial Fibrillation
Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- Conquer-AF (NCT07298473)
- Testing
- Sphere-9 Catheter Ablation
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Hypertension, Vascular Diseases
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- SWYFT (NCT07115953)
- Testing
- Symplicity Spyral™ multi-electrode renal denervation system
- Where
- 21 sites in Australia, Belgium and 7 more
- Volunteers
- 130 people
- Sponsor
- Medtronic Vascular
Atrial Fibrillation
PulseSelect™ PFA Global Registry
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
- Trial name
- NCT06393920
- Where
- 43 sites in Australia, Belgium and 14 more
- Volunteers
- 1,950 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Heart Failure, Bradycardia
Bolt CSP-M Holter Study
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation…
- Trial name
- NCT06540521
- Testing
- No intervention
- Where
- 2 sites in China
- Volunteers
- 95 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hypertension, Vascular Diseases
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- NCT05198674
- Testing
- Renal Denervation (Symplicity Spyral™)
- Where
- 97 sites in United States, Australia and 9 more
- Volunteers
- 1,899 people
- Sponsor
- Medtronic Vascular
Arteriovenous Malformation, Gastrointestinal Bleed
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess…
- Conditions
- Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid
- Trial name
- NCT07639853
- Testing
- Concerto Versa™ Detachable Coils
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Medtronic Endovascular
Ventricular Tachycardia (VT), Ventricular Fibrillation
Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients.
- Trial name
- NCT06745778
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aging
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC
To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - 1) hospital (Acute Care for Elderly Unit) and 2)…
- Trial name
- NCT06638060
- Where
- Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Surgical Procedure, Unspecified, Intensive Care Units (ICUs)
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC
To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - in hospital and at-home, in patients undergoing…
- Trial name
- NCT06638073
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Intervertebral Disc Degeneration
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- Trial name
- MASTERS-D2 (NCT02617563)
- Testing
- Minimally invasive lumbar fusion
- Where
- 27 sites in Argentina, Austria and 15 more
- Volunteers
- 361 people
- Sponsor
- Medtronic Spinal and Biologics
Peripheral Arterial Hemorrhage, Trauma
Onyx™ Liquid Embolic IDE Clinical Study
The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
- Conditions
- Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer
- Trial name
- NCT06742801
- Testing
- Onyx™ Liquid Embolic System
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Medtronic Endovascular
Atrial Fibrillation
Affera Global Registry
The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with…
- Trial name
- NCT06026345
- Testing
- Affera Platform
- Where
- 20 sites in Austria, Belgium and 11 more
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- NCT04235491
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Intracranial Aneurysm
The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).
The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.
- Trial name
- ARTISSE (NCT02998229)
- Testing
- Artisse™ Intrasaccular Device
- Where
- 25 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- Micra CED (NCT03039712)
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Ventricular Arrhythmia, Tachycardia
Enlighten Study: The EV-ICD Post Approval Registry
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.
- Trial name
- NCT06048731
- Testing
- Defibrillation using EV-ICD
- Where
- 130 sites in United States, Austria and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic
Heart Failure With Preserved Ejection Fraction (HFpEF)
ELEVATE-HFpEF Clinical Study
ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing…
- Trial name
- ELEVATE-HFpEF (NCT06678841)
- Testing
- Personalized cardiac pacing
- Where
- 51 sites in United States, Australia and 13 more
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure