Clinical Trials About "approves Medtronic Attain Stability Quad SureScan left heart" RSS

02:42 EDT 16th September 2019 | BioPortfolio

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Showing "approves Medtronic Attain Stability Quad SureScan left heart" Clinical Trials 1–25 of 10,000+

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Attain Success Trial

The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.

Personalized CRT - Attain Stability Quad Post-Approval Study

The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

Attain Model 4196 Left Ventricular (LV) Lead

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CR...

EMRI SureScan™ Clinical Study

The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm® MRI SureScan™ Pacing System.

Attain StarFix™ Model 4195 Left Ventricular Lead

People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest area. This device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to...


Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients

The purpose of this study is to determine if the Medtronic Resting Heart Bypass system is safer and results in less inflammatory reaction than traditional bypass machines used in coronary artery bypass surgery. We hypothesize that the new Medtronic Resting Heart System is safer and results in much less systemic inflammatory reaction in comparison to the standard cardiopulmonary bypass systems currently in use.

Imaging Study of Lead Implant for His Bundle Pacing

The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.

Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults

A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects will be randomized to seven treatment groups to receive Quad-NIV or an active comparator.

Model 4296 Left Ventricular (LV) Lead Study

This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Apogee, Addendum to the Destination Therapy Post Approval Study (DT PAS)

Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy. The Apogee study is conducted within Medtronic's Product Surveillance Platform.

CareLink® Evaluation

The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.

Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure

The purpose of this study is to evaluate whether patients with chronic heart failure not due to coronary artery disease who require use of a left ventricular assist device (LVAD) for refractory heart failure can recover sufficient heart function to allow the pump to be explanted. The study aims to avoid the need for transplantation in these patients by using standard heart failure medications to reduce the size of the left ventricle and then using the investigational drug, clen...

Stimulus Intensity in Left Ventricular Leads

Cardiac resynchronization therapy (CRT) is a device implanted to improve the function of some people's hearts. CRT involves the placement of 3 wires in the heart through a vein near the front of your left or right shoulder into three pumping chambers of the heart, the most important being the left lower chamber (left ventricle). The purpose of CRT is to send small amounts of energy (called pacing) through the wires to both the left and right lower chambers of your heart at (o...

Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome

There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer. Because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in children with hypoplastic left heart syndrome. The purpose of this research study is to help the investigators learn more about developmental disabilities in children w...

Left Atrium Appendage Closure by Surgery-2

Atrial fibrillation is a heart rhythm disorder that often occurs after heart surgery. During atrial fibrillation blood cloths may form, predominantly in the left atrial appendage, a small sac in the wall of the left side of the heart. Some heart surgeons close this appendage to protect against stroke, particularly in patients with a history of atrial fibrillation, yet there is little evidence to support the efficacy and safety of this practice. We therefore conducted the Left ...

Sacral Nerve Stimulation in Improving Bladder After Acute Traumatic Spinal Cord Injury

In the first 3 months after spinal cord injury, patients will be randomized to receive and implantable sacral neuromodulator that will stimulate bilateral S3 nerve roots. These patients will be compared to those receiving standard neurogenic bladder care. Multiple primary and secondary endpoints will be compared based upon urodynamic parameters, quality of life measurements, and clinical outcomes.

Optimal Left Ventricular Lead Positioning During Cardiac Resynchronisation Therapy; Comparison of Two Methods of Targeting

Cardiac Resynchronisation Therapy (CRT) is a well-known treatment for patients with heart failure. It is a special pacemaker that consists of three pacing wires, which are implanted in the right upper and bottom chambers of the heart and via a vein on the surface of the main pumping chamber (left bottom chamber). CRT helps by improving co- ordination between the top and the bottom chambers of the heart. By stimulating the heart from the left and right bottom chambers, co-ordina...

Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM)

In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive value for detecting heart failure. We also investigate if left ventricular filling pattern measured by echocardiography and/or brain natriuretic peptide (BNP) level can be used to improve the positive predictive value of the Optivol alert

Dual Site Left Ventricular (LV) Pacing

The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing: 1. Improves the way the heart's left ventricle functions 2. Decreases the number of hospital and clinic visits for heart failure related symptoms 3. Slows the rate patients experience certain heart failure symptoms 4. Reduces uncoordinated heart contractions

PANORAMA 2 Observational Study

Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing products. In addition Medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability. The Pan...

OptiLink HF Study: Optimization of Heart Failure Management Using Medtronic OptiVol Fluid Status Monitoring and Medtronic CareLink Network

Patients suffering from heart failure and a markedly reduced pumping capacity and sometimes desynchronization of the lower chambers of the heart have a higher risk of suffering sudden cardiac death. These patients can be treated with an Implantable Cardiac Defibrillator that terminates dangerously fast heartbeats and in case of asynchronous pumping of the heart can also re-synchronize the lower chambers of the heart (ICD- or CRT-D-system). Patients that moreover suffered...

PET Scan to Determine Areas of Blood Flow and Activity in the Hearts of Patients With Heart Disease Taking Beta-Blockers

The human heart is divided into four chambers. One of the four chambers, the left ventricle, is the chamber mainly responsible for pumping blood out of the heart into the circulation. Diseases of the heart like congestive heart failure (CHF), can cause the left ventricle to function improperly. Medications called beta-blockers appear to reverse the abnormalities in the left ventricle and frequently improve the function of the left ventricle in patients with different kinds ...

Sensor Optimization of Cardiac Resynchronization Therapy Response

The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes in patients indicated for cardiac resynchronization therapy.

Autologous Cardiac Stem Cell Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study.

Male or female neonates, < 28 days (inclusive) diagnosed with hypoplastic left heart syndrome (HLHS) undergoing Stage I surgery. A total of 30 patients will be enrolled for this pilot study in a staged enrollment diagnosed with HLHS.All patients will be followed for 12 months post-treatment.

CMC I Stability Intraoperative

The goal of the current study is to objectively measure intraoperative the initial thumb stability after trapezium removal when performing trapeziectomy, alone or in combination with suspension and tendon interposition and to evaluate if there are differences in the stability between the patients and with the different surgical steps. Additionally, the subjective stability rating of the surgeon will be compared with the objective measures and if there is a correlation between c...

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