Clinical trials: Conduction Block
Sinus Node Dysfunction, Brady Tachy Syndrome
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
- Trial name
- NCT01170611
- Testing
- PACEMAKER SYMPHONY 2550
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 400 people
- Sponsor
- LivaNova
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
Sick Sinus Syndrome, AV Block
HBP Device EGM Data Collection
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac…
- Conditions
- Sick Sinus Syndrome, AV Block, Heart Failure
- Trial name
- NCT03564860
- Testing
- Device data collection
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
Atrioventricular Conduction Block
Micra Atrial TRacking Using A Ventricular AccELerometer 2
The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal…
- Trial name
- MARVEL2 (NCT03752151)
- Testing
- MARVEL 2 Algorithm Monitor Mode then Adaptive Mode
- Where
- 12 sites in United States, Austria and 6 more
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Resynchronization Therapy, Chronic Heart Failure
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from…
- Conditions
- Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
- Trial name
- CRT-DRIVE (NCT05327062)
- Testing
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Where
- 13 sites in United States, Austria and 5 more
- Volunteers
- 150 people
- Sponsor
- XSpline S.p.A.
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
Hypertension Resistant to Conventional Therapy, Bradycardia
Safety and Performance Study of the Moderato System
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02282033
- Testing
- The Moderato System
- Where
- 10 sites in Austria, Chile and 5 more
- Volunteers
- 57 people
- Sponsor
- BackBeat Medical Inc
Heart Failure With Reduced Ejection Fraction
Improving CRT Outcome With Non-Invasive Cardiac Mapping
The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement.
- Trial name
- ICONIC-M (NCT05564793)
- Testing
- Pre-implantation planning, Post-implantation assessment
- Where
- 11 sites in Netherlands, Portugal and 2 more
- Volunteers
- 330 people
- Sponsor
- EP Solutions SA
Sinus Node Dysfunction, Bradycardia
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA).
- Conditions
- Sinus Node Dysfunction, Bradycardia, Atrioventricular Block
- Trial name
- BIO-CONDUCT (NCT06540079)
- Testing
- Solia CSP S lead
- Where
- 10 sites in United States
- Volunteers
- 192 people
- Sponsor
- Biotronik, Inc.
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
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 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.
Sinus Node Disease
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence…
- Trial name
- B3 (NCT02579889)
- Testing
- DDD+CLS, DDD(R)
- Where
- 54 sites in China, Hungary and 7 more
- Volunteers
- 1,390 people
- Sponsor
- Biotronik SE & Co. KG
Death, Sudden, Cardiac, Ventricular Fibrillation
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias. To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for their association…
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- GAME (NCT00664807)
- Where
- United States
- Volunteers
- 1,023 people
- Sponsor
- Medtronic Corporate Technologies and New Ventures
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
Heart Failure, Left Bundle-Branch Block
Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and…
- Trial name
- MAP HIS HF (NCT03803995)
- Testing
- Mapping and Pacing the His Bundle, Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Abbott Medical Devices
Sick Sinus Syndrome
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
- Trial name
- NCT00161538
- Testing
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Where
- 12 sites in Germany
- Volunteers
- 456 people
- Sponsor
- Medtronic BRC
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Sick Sinus Node Syndrome
Model 20105 Lead Study
The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.
- Trial name
- NCT02301429
- Testing
- Model 20105
- Where
- 4 sites in Canada, Netherlands and 2 more
- Volunteers
- 16 people
- Sponsor
- Medtronic BRC