Clinical trials: Pacing Therapy
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Heart Failure
Quartet Lead and Resynchronization Therapy Options III (QUARTO_III)
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with…
- Trial name
- QUARTO_III (NCT02476201)
- Testing
- MPP ON
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Ventricular Dysfunction
Safety and Performance of Electrodes Implanted in the Left Ventricle
The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure…
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases
- Trial name
- SELECT-LV (NCT01905670)
- Testing
- WiCS-LV system
- Where
- 2 sites in Czechia, Denmark
- Volunteers
- 39 people
- Sponsor
- EBR Systems, Inc.
Non-left Bundle Branch Block, Ischemic or Non-ischemic Cardiomyopathy
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population.
- Trial name
- ENHANCE CRT (NCT01983293)
- Testing
- QLV based implant strategy, Standard of care implant strategy
- Where
- 32 sites in United States
- Volunteers
- 248 people
- Sponsor
- Abbott Medical Devices
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Central Sleep Apnea
Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of overdrive pacing.
- Trial name
- Morpheus (NCT00551499)
- Testing
- CRT + AOP
- Where
- 2 sites in Germany
- Volunteers
- 44 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Left Bundle-Branch Block
LV Only MPP With SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy…
- Trial name
- NCT03567096
- Testing
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Acute Myocardial Infarction, Pacing Therapy
Post-Myocardial Infarction Remodeling Prevention Therapy
The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial…
- Conditions
- Acute Myocardial Infarction, Pacing Therapy, Cardiac Remodeling, Heart Failure
- Trial name
- PRomPT (NCT01213251)
- Testing
- Single Site Pacing, Dual Site Pacing
- Where
- 26 sites in United States, Denmark and 5 more
- Volunteers
- 129 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
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.
- Trial name
- 4296 (NCT00927251)
- Testing
- Pacing Lead (Model 4296 LV Lead)
- Where
- 16 sites in Austria, Finland and 6 more
- Volunteers
- 90 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Electrophysiology
Transvenous Lead Removal Post-Market Clinical Study
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any…
- Trial name
- NCT03688412
- Testing
- Cook lead extraction devices
- Where
- 9 sites in United States, Germany and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Cook Research Incorporated
Heart Failure
QuickFlex Micro Left Ventricular Lead Post Approval Study
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
- Trial name
- NCT01179477
- Testing
- Implantation of a QuickFlex® μ Model 1258T LV Lead
- Where
- 77 sites in United States
- Volunteers
- 1,930 people
- Sponsor
- Abbott Medical Devices
Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle…
- Trial name
- PIRAT (NCT04844892)
- Testing
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
Heart Failure
Assessment of AAIR Pacing Treatment for Heart Failure Patients With Chronotropic Incompetence
The primary objective of this study is to assess the clinical efficacy of AAIR (Atrial-paced Atrial-sensed Inhibitory Rate-Modulated) pacing treatment for heart failure (HF) patients with chronotropic incompetence (CI) in terms…
- Trial name
- NCT03071952
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Model 4396 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 and effective.
- Trial name
- 4396 (NCT00853593)
- Testing
- Pacing Lead
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 197 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacing, Pacing Therapy
Electrogram and Hemodynamic Characteristics of Adaptive LBBAP in Patients With Heart Failure or Bradycardia
This is a multi-site, non-randomized, data collection study. The purpose of this study is to investigate the cardiac electrical and mechanical function during LBBAP with different AV intervals.
- Trial name
- NCT04738396
- Where
- 4 sites in China
- Volunteers
- 52 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1)…
- Trial name
- NCT00180258
- Testing
- Cardiac Resynchronization Therapy with & without defibrillator
- Where
- United States
- Volunteers
- 2,200 people
- Sponsor
- Boston Scientific Corporation
Tachycardia
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and…
- Trial name
- OPTION (NCT00729703)
- Testing
- Ovatio DR 6550
- Where
- 55 sites in United States, Belgium and 7 more
- Volunteers
- 462 people
- Sponsor
- LivaNova
Bradycardia, A-V Block
PV Loops With CNT in Multiple Pacing Sites
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV.
- Trial name
- CS-07 (NCT05345925)
- Testing
- Moderato
- Where
- Poland
- Volunteers
- 5 people
- Sponsor
- BackBeat Medical Inc
Heart Failure
Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy (CRT), in Chinese Heart Failure (HF)…
- Trial name
- NCT03071978
- Testing
- CRT with LV-only pacing / bi-ventricular pacing
- Where
- 5 sites in China
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic