Clinical trials: Left Heart Failure
Heart Failure
Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study
Lead survivability will be summarized.
- Trial name
- NCT02294331
- Where
- 100 sites in United States, Belgium and 6 more
- Volunteers
- 1,900 people
- Sponsor
- Medtronic
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
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.
Heart Failure
BAROSTIM® Hope for Heart Failure Study
The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).
- Trial name
- HOPE4HF (NCT01720160)
- Testing
- BAROSTIM NEO® System, Standard of care medical managment therapy for heart failure
- Where
- 23 sites in United States
- Volunteers
- 98 people
- Sponsor
- CVRx, Inc.
Congestive Heart Failure, Left Ventricular Systolic Dysfunction
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.
- Trial name
- SchlaHF (NCT01500759)
- Where
- 199 sites in Australia, Germany
- Volunteers
- 6,876 people
- Sponsor
- ResMed
Heart Failure
A Phase II Trial to Assess Hemodynamic Effects of Istaroxime in Pts With Worsening HF and Reduced LV Systolic Function
The purpose of this study is to determine the minimum effective dose of Istaroxime, in patients requiring hospitalization for deterioration of chronic heart failure and left ventricular systolic dysfunction.
- Trial name
- HORIZON-HF (NCT00616161)
- Testing
- Istaroxime
- Volunteers
- 120 people
- Sponsor
- sigma-tau i.f.r. S.p.A.
Heart Failure
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP
The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.
- Trial name
- NCT02099448
- Where
- Israel
- Volunteers
- 41 people
- Sponsor
- CorAlert Ltd.
Heart Failure
REmodeling the Left Ventricle With Atrial Modulated Pacing
New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.
- Trial name
- REVAMP (NCT03210402)
- Testing
- Elevated night pacing on, Elevated night pacing off
- Where
- 10 sites in United States
- Volunteers
- 22 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Heart Failure
Attain Performa(TM) Quadripolar Lead Study
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure.
- Trial name
- NCT01751022
- Testing
- Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
- Where
- 121 sites in United States, Australia and 25 more
- Volunteers
- 1,202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Myocardial Infarction
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.
- Trial name
- PARADISE-MI (NCT02924727)
- Testing
- LCZ696 (sacubitril/valsartan), Ramipril, Valsartan
- Where
- 486 sites in United States, Argentina and 39 more
- Volunteers
- 5,669 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Congestive Heart Failure
COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac…
- Trial name
- NCT00396136
- Testing
- Corox OTW Steroid Left Ventricular Lead
- Where
- United States
- Volunteers
- 221 people
- Sponsor
- Biotronik, Inc.
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
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Heart Failure
C-Pulse® System: A Heart Assist Device Clinical Study
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse").
- Trial name
- COUNTER-HF (NCT01740596)
- Testing
- C-Pulse® System Counterpulsation
- Where
- 28 sites in United States
- Volunteers
- 38 people
- Sponsor
- Nuwellis, Inc.
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Advanced Refractory Left Ventricular Heart Failure
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS).
- Trial name
- SWIFT (NCT04548128)
- Testing
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Where
- 32 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing…
- Trial name
- SYNSEQ (NCT02914457)
- Testing
- Electrophysiological Study
- Where
- 7 sites in Poland, Slovakia and 3 more
- Volunteers
- 31 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure