Clinical trials: Bradyarrhythmia
Bradycardia, Sinus Node Dysfunction
Safety and Performance Study of the INGEVITY Lead
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Trial name
- NCT01688843
- Testing
- INGEVITY lead
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Sinus Node Dysfunction
ImageReady(TM) MR Conditional Pacing System Clinical Study
The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with…
- Trial name
- SAMURAI (NCT01781078)
- Testing
- MRI, ImageReady System implant
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 363 people
- Sponsor
- Boston Scientific Corporation
Bradycardia
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by…
- Trial name
- NCT00311168
- Testing
- Intervention/treatment
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Bradycardia
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
- Trial name
- NCT04346537
- Testing
- INGEVITY+™ Pace/Sense Lead
- Where
- 13 sites in United States
- Volunteers
- 109 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Heart Failure
BIO|CONCEPT.Amvia Study
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P)…
- Trial name
- NCT05610176
- Testing
- Amvia Sky pacemaker or CRT-P device
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Bifascicular Block, Syncope
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Study Objective The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to patient symptoms in patients with bifascicular block and syncope of unexplained origin.
- Trial name
- PRESS (NCT01463358)
- Testing
- DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
- Where
- 12 sites in Italy
- Volunteers
- 101 people
- Sponsor
- Boston Scientific Corporation
Reversal of Neuromuscular Blockade
Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of…
- Trial name
- NCT03346057
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Sugammadex 16 mg/kg
- Where
- 30 sites in United States, Austria and 2 more
- Volunteers
- 344 people
- Sponsor
- Merck Sharp & Dohme LLC
Bradycardia
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing…
- Trial name
- COMPARE (NCT01039467)
- Testing
- Medtronic Adapta Dual Chamber Pacemaker
- Where
- 30 sites in China
- Volunteers
- 385 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
Bradycardia
INGEVITY™ Observational Trial
The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2.
- Trial name
- GENTLE (NCT02166606)
- Testing
- ImageReady MR Conditional Pacing System Implant
- Where
- 60 sites in Austria, Belgium and 11 more
- Volunteers
- 1,184 people
- Sponsor
- Boston Scientific Corporation
Shortness of Breath Episode, Tachycardia
Verification of Prediction Algorithm
Prospective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.
- Conditions
- Shortness of Breath Episode, Tachycardia, Bradycardia, Difficulty Breathing
- Trial name
- VPAC (NCT02863666)
- Where
- 3 sites in United States, Belgium
- Volunteers
- 673 people
- Sponsor
- Zoll Medical Corporation
Bradycardia
Micra Transcatheter Pacing System Continued Access Study Protocol
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
- Trial name
- NCT02488681
- Testing
- Micra Pacemaker Implant
- Where
- 29 sites in United States
- Volunteers
- 285 people
- Sponsor
- Medtronic
Cardiac Rhythm Disorder, Bradycardia
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
- Trial name
- NCT04559945
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- 53 sites in United States, Canada and 6 more
- Volunteers
- 1,276 people
- Sponsor
- Abbott Medical Devices
Bradycardia
China Micra Transcatheter Pacing Study
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for…
- Trial name
- NCT03624504
- Testing
- Micra Transcatheter Pacing System (TPS)
- Where
- 7 sites in China
- Volunteers
- 82 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sinus Bradycardia, Sinus Node Disease
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
- Conditions
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block
- Trial name
- IES-ACap (NCT00832260)
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Bradyarrhythmia
Micra Accelerometer Sensor Study 2
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future…
- Trial name
- MASS2 (NCT02930980)
- Testing
- Investigational Software loaded on Micra device
- Where
- 4 sites in Austria, France and 1 more
- Volunteers
- 43 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Pacing
Model 4965 Post-Approval Study
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
- Conditions
- Heart Failure, Pacing, Bradycardia, Arrhythmia
- Trial name
- NCT01076348
- Where
- 107 sites in United States, Australia and 12 more
- Volunteers
- 73 people
- Sponsor
- Medtronic