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Heart Diseases clinical trials

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NCT ID: NCT05902013 Recruiting - Clinical trials for Congenital Heart Disease

Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

Start date: September 21, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to perform a pilot study investigating the first attempt intubation success rate differing between video laryngoscope nasotracheal intubation and direct laryngoscope nasotracheal intubation. The study population will consist of 60 neonates and infants with congenital heart disease less than 1 year of age who need nasotracheal intubation during general anesthesia for cardiac procedures. Standard nasotracheal intubation will be performed using either a video laryngoscope or direct laryngoscopy. Neonates and infants will be randomly assigned (1:1) to standard video laryngoscopy (with one of the following systems: Storz C-MAC Miller Video Laryngoscope, Karl Storz, Tuttlingen, Germany or Mc Grath Video Laryngoscope, Medtronic, Boulder,USA) or to direct laryngoscopy with one of the following blades: Miller or Macintosh (Heine, Hersching, Germany).

NCT ID: NCT05895487 Recruiting - Clinical trials for Mitral Valve Insufficiency and Aortic Valve Insufficiency

Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease

Start date: November 1, 2022
Phase:
Study type: Observational

Acquired heart diseases continue to remain one of the most common causes of cardiac mortality and morbidity. In the Russian Federation, open surgery treatment of acquired valvular heart diseases (AVHD) is performed in more than 40 regions by specialists from 92 healthcare organizations. Treating aortic or mitral valve disease using the "UniLine" biological prosthesis is expected to improve survival rates. Supposedly, in vivo the "UniLine" biological prosthesis will show optimal hemodynamic characteristics and high resistance to structural valve degeneration and infectious damage, thus lowering the risk of dysfunction. Moreover, the risk of repeated intervention due to dysfunction of the "UniLine" bioprosthesis should not exceed the risk of the primary implantation. Supposedly, in the case of dysfunction of "UniLine" bioprosthesis it would be possible to perform repeated replacement using valve-in-valve technique. The aim of the study is to assess the effectiveness, safety, durability of the "UniLine" epoxy-treated prosthesis and the long-term outcome of the treatment of isolated mitral and aortic valve diseases using this prosthesis. In accordance with the objectives and hypothesis, the following data will be analyzed: actuarial and linear survival rates (general and cardiac), non-lethal prosthesis-associated complications, prosthetic dysfunction and repeated interventions. Moreover, in vivo hemodynamic parameters of the prosthesis will be assessed: the area of the effective opening surface, peak and mean gradient of pressure and blood flow velocity. The study will be conducted at the Research Institute of Complex Issues of Cardiovascular Diseases. Study protocol received sponsorship approval and approval by Local Ethics Committee of the Research Institute and Research Coordinating Committee. The study will enroll patients who underwent isolated mitral or aortic valve replacement; transthoracic echocardiography will be conducted in all patients available for in-person visit.

NCT ID: NCT05892588 Recruiting - Clinical trials for Aortic Valve Stenosis

Prevalence Study of Cardiovascular Diseases in a Population ≥ 65 Years in Italy

PREVASC
Start date: June 1, 2022
Phase:
Study type: Observational [Patient Registry]

This registry is a large-scale epidemiological study (PREVASC) aimed at estimating the prevalence of symptomatic and asymptomatic valvular hear disease in men and women aged over 65 years randomly selected in Italy.

NCT ID: NCT05885113 Recruiting - Infant Development Clinical Trials

Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease

Start date: October 10, 2023
Phase: N/A
Study type: Interventional

The proposed study includes a newborn developmental intervention to improve neurodevelopmental (ND) and medical outcomes for infants with congenital heart disease (CHD) with improved parent well-being. Literature documents long-term ND disabilities for children with CHD, caused by the negative effects of the hospital environment on the developing newborn brain. The cardiac intensive care unit (CICU), while necessary to save the life of the infant with CHD, exposes infants to overwhelming stress through painful procedures, invasive lines and tubes, toxic sensory stimulation, and separation from family. The combination of these negative experiences disrupts the infant's brain maturation and subsequent neurodevelopment. Individualized developmental care (IDC) is an intervention that minimizes the mismatch between infant neurobiological needs and the harsh hospital environment, thereby diminishing the frequency and severity of adverse effects. Core components of IDC include support for parent engagement, caregiving provided in a way to reduce infant stress, providing a soothing environment and appropriately positioning to enhance musculoskeletal and motor development. Research shows that IDC improves outcomes for preterm infants with enhanced brain structure and function, cognitive skills, executive functioning, behavioral outcomes, and family satisfaction from infancy to school age. Despite all the positive evidence for IDC, my past research showed most CICUs do not implement IDC due to lack of staff education and no evidence supporting IDC in CHD. The investigators propose the first randomized controlled trial to evaluate the efficacy of IDR as an intervention for children with CHD. The investigators hypothesize infants receiving IDC provided in the hospital, compared to those not receiving IDC, will show improved medical outcomes (including shorter hospital stay, improved oral feeding, increased growth), improved developmental competence, and increased parent coping at the time of discharge home and 3 months after discharge. With support from the Children's Heart Foundation, the investigators can demonstrate the feasibility and safety of implementing IDC in the CICU, the potential to improve the ND outcome for infants with CHD and increase parent well-being. This study would serve as the needed pilot study to request funding for a larger multicenter trial which would impact CICU care of infants with CHD and their families around the world.

NCT ID: NCT05881564 Recruiting - Clinical trials for Congenital Heart Disease

Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. The main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter ICU and hospital length of stay.

NCT ID: NCT05873920 Recruiting - Clinical trials for Cardiovascular Diseases

Atrial Fibrillation and Diabetes Mellitus

Start date: May 9, 2023
Phase:
Study type: Observational [Patient Registry]

Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.

NCT ID: NCT05873881 Recruiting - Heart Failure Clinical Trials

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

COLT-HF
Start date: January 29, 2024
Phase: Phase 3
Study type: Interventional

The goal of this 2x2 factorial clinical trial is to test the efficacy of i) colchicine, and ii) thiamine in heart failure (HF) secondary to ischemic heart disease. The main questions it aims to answer are: - Does colchicine reduce the risk of cardiovascular (CV) death, a HF event, or an ischemic CV event - Does thiamine reduce the risk of cardiovascular (CV) death, or a HF event Participants will undergo the following procedures: - Run-in: All participants will receive colchicine 0.5 mg daily to assess drug tolerance over a 3-4 week period. - Randomization: If colchicine is tolerated during run-in, eligible participants will be randomized in a 2x2 factorial design to receive i) colchicine 0.5mg daily or placebo, and ii) thiamine 300mg daily or no thiamine. - Follow-up: Clinical outcomes, side effects, adverse events, and drug adherence will be captured during follow-up

NCT ID: NCT05869214 Recruiting - Heart Failure Clinical Trials

Middle East African Registry Women CardioVascular Disease

MEA-WCVD
Start date: May 10, 2023
Phase:
Study type: Observational [Patient Registry]

The MEA cardiology societies have joined forces to tackle the issue by establishing a tangible real-world data registry in every MEA country. This endeavor has resulted in the development of a multicenter registry called MEA-WCVD, which is being sponsored by each national cardiology society from participating countries. All data gathered will be consolidated into a singular registry for thorough analysis. Country specific analysis will be performed.

NCT ID: NCT05868616 Recruiting - Heart Failure Clinical Trials

Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

NIME-CRT
Start date: March 21, 2023
Phase:
Study type: Observational

Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis. Cardiac resynchronization therapy (CRT) has been one of the most important advancements in the past two decades for patients with LBBB heart failure. However, 30-40% of patients receiving a CRT do not benefit from it. In this study, the investigators will test a noninvasive device to evaluate acute effect of CRT during implantation and at follow-up CRT controls. In addition, echocardiography will be performed during CRT turned ON and OFF to visualize the changes in intraventricular flow and functional parameters of the heart.

NCT ID: NCT05867381 Recruiting - Atherosclerosis Clinical Trials

Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History

SAPIA
Start date: July 11, 2023
Phase: N/A
Study type: Interventional

This double-blind, randomized, crossover trial aims to test the hypothesis that longer-term indoor air filtration intervention can slow atherothrombosis progression by reducing indoor fine particulate matter (PM2.5) exposure in adults with ischemic heart disease history.