Clinical trials: Heart Block
Heart Failure, Systolic Bundle Branch Block, Left
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator…
- Trial name
- ACHIEVED LBBAP (NCT07526896)
- Testing
- LBBAP Therapy, LOT-CRT, ICD
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
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
Atrial Fibrillation (AF), Atrial Flutter
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT)
- Trial name
- Japan H2H (NCT07870837)
- Testing
- Application of ambulatory cardiac monitor
- Where
- 4 sites in Japan
- Volunteers
- 130 people
- Sponsor
- iRhythm Technologies, Inc.
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 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
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
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
Heart Failure, Left Bundle-Branch Block
Mid-Q Response Study
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.
- Conditions
- Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II
- Trial name
- NCT04180696
- Testing
- aCRT ON, aCRT OFF
- Where
- 61 sites in Brunei, China and 8 more
- Volunteers
- 177 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
Cardiopulmonary Failure, Myocardial Infarction (MI)
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using…
- Conditions
- Cardiopulmonary Failure, Myocardial Infarction (MI), Heart Decompensation, Heart Failure
- Trial name
- COR-INSIGHT (NCT06763549)
- Testing
- SUBPROTOCOL A, SUBPROTOCOL B, SUBPROTOCOL C
- Where
- United States
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
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
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, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
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
Heart Block, Valve Heart Disease
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter
This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or…
- Trial name
- NCT06261788
- Testing
- Temporary pacing
- Where
- Paraguay
- Volunteers
- 30 people
- Sponsor
- Swift Sync, Inc.
Symptomatic First-degree Heart Block
Physiologic Pacing for Symptomatic First-Degree Heart Block
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).
- Trial name
- NCT06245304
- Testing
- Dual chamber Medtronic pacemaker implantation., DDD-50 pacing program, AAI-DDD 50 pacing program
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Ascension Health