Clinical trials: sponsored by Medtronic
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmias, Heart Failure
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00526162
- Testing
- Bi-ventricular Implantable Cardioverter Defibrillator
- Where
- Germany
- Volunteers
- 83 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia
PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)
- Trial name
- PORTLink (NCT03125382)
- Testing
- Carelink System, In office standard visit
- Where
- 6 sites in Portugal
- Volunteers
- 141 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Congestive
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related…
- Trial name
- SENSE-HF (NCT00400985)
- Testing
- Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.
- Where
- 2 sites in Belgium, United Kingdom
- Volunteers
- 501 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient.
- Trial name
- NCT01513538
- Testing
- TherapyGuide
- Where
- France
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
- Trial name
- NCT01522755
- Testing
- Pacing system implant with the CapsureFix MRI pacing lead model 5086
- Where
- France
- Volunteers
- 409 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex.
- Trial name
- V3 (NCT01059175)
- Testing
- Additional Endocardial or Epicardial LV Lead, CRT-P or CRT-D
- Where
- France
- Volunteers
- 84 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Patients With an Indication for an ICD Implantation According to the Guidelines
Protecta Smart Analysis Register
ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent…
- Trial name
- ProSA (NCT01714921)
- Volunteers
- 504 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CARE-HF Long Term Follow-up
The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up.
- Trial name
- NCT00318357
- Testing
- Continuation of CRT, Upgrade to CRT
- Where
- United Kingdom
- Volunteers
- 309 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).
- Trial name
- iSPOT (NCT01883141)
- Testing
- Electrophysiological Study
- Where
- 8 sites in Belgium, Israel and 2 more
- Volunteers
- 31 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Disease
Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better…
- Trial name
- ADVANCEIII (NCT00617175)
- Testing
- Implantable Defibrillator
- Where
- 91 sites in Belgium, Denmark and 12 more
- Volunteers
- 1,902 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Myocardial Infarction
CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction
The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several…
- Trial name
- NCT00145119
- Where
- Netherlands
- Volunteers
- 312 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmia
Full Automaticity and Remote Follow-up
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years.
- Trial name
- NCT01526629
- Where
- France
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Brief Loss of Consciousness
Applicability of Syncope Guidelines in Cataluña
The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of…
- Trial name
- SYNCAT (NCT01721369)
- Testing
- Transient Loss of Consciousness (T-LOC)
- Volunteers
- 581 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Death, Sudden, Cardiac, Ventricular Fibrillation
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- DISCOVERY (NCT00478933)
- Testing
- Defibrillator, Dual Chamber ; Implantable, Blood sampling
- Volunteers
- 1,223 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CareLink® Network 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.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)
The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.
- Trial name
- DOT-HF (NCT00480077)
- Testing
- Programming (CRT-D, ICD OptiVol® and Cardiac Compass® )
- Where
- Netherlands
- Volunteers
- 335 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmias
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT00526227
- Testing
- Secura ICD
- Where
- 13 sites in Austria, Finland and 5 more
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Heart Failure, Congestive
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent…
- Trial name
- NCT00262119
- Testing
- Pacemaker Medtronic EnRhythm
- Where
- Italy
- Volunteers
- 1,300 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.
- Trial name
- ADVANCE-CRTD (NCT00147290)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 526 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure