Clinical trials: Heart Rate Low
Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome
Spontaneous Atrio Ventricular Conduction Preservation
In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.
- Conditions
- Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome, Paroxysmal Atrioventricular Block
- Trial name
- SAVER (NCT00655213)
- Testing
- Symphony D 2450, Symphony DR 2550
- Where
- 67 sites in Belgium, France and 3 more
- Volunteers
- 622 people
- Sponsor
- LivaNova
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation (AF), Arrhythmias Cardiac
Detection and Classification of Cardiac Rhythm and Atrial Fibrillation Using a Finger-worn Ring
Everbeat is a finger-worn ring that has a built-in electrocardiogram (ECG). In this study the investigators ensure that the ECG as read by the everbeat correctly classifies heart rhythms and detects atrial fibrillation.
- Conditions
- Atrial Fibrillation (AF), Arrhythmias Cardiac, Tachycardia, Palpitations
- Trial name
- FINDER-AF (NCT06892938)
- Testing
- Atrial Fibrillation Identification
- Where
- 3 sites in United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Everbeat
Bradycardia
P3: Pacemaker Patient Profiling Study
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
- Trial name
- NCT00294060
- Where
- 83 sites in United States
- Volunteers
- 2,013 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients
This study will compare how two different sensors inside the pacemaker may affect patients' quality of life.
- Trial name
- NCT00146861
- Testing
- sensor programming
- Volunteers
- 1,500 people
- Sponsor
- Boston Scientific Corporation
Hypertension, Hypertension, Systolic
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure…
- Conditions
- Hypertension, Hypertension, Systolic, Hypertension, Essential
- Trial name
- BACKBEAT (NCT06059638)
- Testing
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated, Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
- Where
- 131 sites in United States, Australia and 13 more
- Volunteers
- 316 people
- Sponsor
- Orchestra BioMed, Inc
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
- Trial name
- OPTI-MIND 2 (NCT01715558)
- Where
- 39 sites in Belgium, Denmark and 7 more
- Volunteers
- 514 people
- Sponsor
- Boston Scientific Corporation
Bradycardia
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
- Trial name
- SHAPE (NCT05440071)
- Testing
- JX- XFINE lead
- Volunteers
- 129 people
- Sponsor
- MicroPort CRM
Sinus Node Dysfunction, Atrioventricular Block
Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode
Observational study on long PR interval using the SafeR mode in bradycardia patients.
- Trial name
- PRECISE (NCT02586480)
- Testing
- dual chamber pacemaker with SafeR algorithm
- Where
- 58 sites in France
- Volunteers
- 848 people
- Sponsor
- LivaNova
Bradycardia
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™…
- Trial name
- INFINITE-MRI (NCT01890512)
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Slow Heart Beat
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 (used in support of Revo MRI™ SureScan…
- Trial name
- NCT00433654
- Testing
- Implantable Pulse Generator (IPG) and Pacing Leads (wires), Magnetic Resonance Imaging (MRI) scan
- Where
- 45 sites in United States, Austria and 9 more
- Volunteers
- 484 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sinus Node Dysfunction
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
- Trial name
- IMPROVE Brady (NCT01643707)
- Testing
- Evidence based guidelines and tools
- Where
- 21 sites in Argentina, Bangladesh and 5 more
- Volunteers
- 1,342 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Pacemaker
BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity.
- Trial name
- BRADYCARE (NCT01062126)
- Volunteers
- 3,389 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrial Fibrillation
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.
- Trial name
- PAFOS (NCT01912326)
- Testing
- Pacemaker Implantation
- Where
- Germany
- Volunteers
- 249 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Atrioventricular Block
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in…
- Conditions
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
- Trial name
- SEPTA PMCF (NCT07209852)
- Testing
- Pacemaker lead
- Where
- 13 sites in Belgium, France and 5 more
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Atrial Tachyarrhythmia
AdvisaTM IPG Clinical Evaluation Study
The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).
- Trial name
- NCT00839384
- Testing
- Advisa IPG
- Where
- Czechia
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
Micra AV Transcatheter Pacing System Post-Approval Registry
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care…
- Trial name
- Micra AV PAS (NCT04253184)
- Testing
- Micra AV Transcatheter Pacing System
- Where
- 89 sites in United States, Belgium and 18 more
- Volunteers
- 802 people
- Sponsor
- Medtronic
Atrial Fibrillation, Bradycardia
Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing
The purpose of this study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave…
- Trial name
- Avoid FFS (NCT00512915)
- Testing
- pacemaker implantation
- Where
- 10 sites in Germany
- Volunteers
- 204 people
- Sponsor
- Abbott Medical Devices