Clinical Trials – Arrhythmias

Arrhythmias. Atrial Fibrillation

You want to evaluate the use of the AI ​​combination and the data obtained from the pacemaker allow you to find patterns or indices that predict the appearance or increase of Atrial Fibrillation.

It also wants to find patterns that predict the appearance of MACE events, hospitalizations, visits to the emergency room, generated by Atrial Fibrillation or Heart Failure.

Inclusion criteria:

Over 18 

Indication for implantation or replacement of DR or CRTp pacemakers.

Exclusion criteria

Kidney hemodialysis

Heart transplant recipient or high probability of Tx during study follow-up.

Pregnancy.

Life expectancy less than one year.

The primary objective of this study is to evaluate whether abelacimab is superior to placebo in reducing the risk of ischemic stroke or systemic embolism (SE) in patients with AF who have been deemed unsuitable for oral anticoagulation therapy.

Inclusion criteria

• Diagnosed AF or atrial flutter (documented on an electrocardiogram or monitor recording)

• Age 65-74 and CHA2DS2VASc ≥5 OR age ≥75 and CHA2DS2VASc ≥4

• Judged by the responsible physician or by his/her own decision to be unsuitable for oral anticoagulation

• At least 1 of the following:

o Severe renal failure (creatinine clearance <30 ml/min by the Cockcroft-Gault formula)

o Planned daily use of aspirin, a P2Y12 inhibitor, or other antiplatelet agent for the duration of the trial

o History of bleeding from a critical area or organ or gastrointestinal bleeding

o Other conditions associated with an increased risk of bleeding (e.g., suspected bleeding disorder; chronic NSAID use (≥3 times per week); frailty; or history of multiple falls

Exclusion criteria.

• History of hypersensitivity to any of the study drugs or their excipients, to drugs of similar chemical classes

• AF due to an ongoing acute reversible cause (eg, cardiac surgery, pulmonary embolism, untreated hyperthyroidism, alcohol consumption)

• Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 90 days prior to randomization

• Patients with intracranial or intraocular hemorrhage within 3 months before screening

• Mechanical heart valve or valve disease expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study

• Patients with a medical condition other than AF for whom the use of an anticoagulant is indicated

• Known presence of an atrial myxoma or left ventricular thrombus

• History or planned left atrial appendage closure or left atrial closure.

• Clinically unstable or active endocarditis or endovascular.

• Planned invasive procedure with potential for uncontrolled bleeding (e.g., major surgery)

• Hemodialysis patients in selection

• Any stroke within 14 days before randomization or TIA within 3 days before randomization

Wants to make a clinical assessment of the usefulness of new electrocardiographic heart rate monitoring technologies in patients scheduled for outpatient electrical cardioversion for atrial fibrillation

Inclusion criteria:

Patients with paroxysmal, persistent or newly diagnosed symptomatic atrial fibrillation or not scheduled for ambulatory electrical cardioversion.

Patients over 18 years of age.

Patients with mobile devices compatible with Kardia and capable of using the devices and performing the ECG recording transmissions required by the protocol.

Patients with the capacity to understand and provide written informed consent.

Exclusion criteria:

ï Patients with atrial fibrillation of estimated origin > 3 months.

Patients with cardiac stimulation devices (e.g., pacemakers, defibrillators…)

Patients with severe left atrial dilation (AP diameter ≥ 5.2 cm in men or ≥ 4.7 cm in women).

Patients with recent failed electrical cardioversion (3 months), cancer undergoing chemotherapy, dialysis, or any other comorbidity that could affect adherence to the protocol.

ï Life expectancy of less than 6 months for any cause.

To analyze the composite outcome of sudden cardiac death or sustained ventricular tachycardia (treated with ICD or documented by any diagnostic method) in chronic ischemic patients without prior evidence of arrhythmia, according to their risk classification using “B” mass.order Zone Chanels»BZC.

Inclusion criteria

Age > 18 years.

Stable chronic ischemic heart disease (>6 months after the index acute coronary event), regardless of LVEF.

Life expectancy > 1 year with good functional status

Signed informed consent.

MRI performed recently (less than 6 months) or scheduled for clinical purposes (routine clinical practice).

Exclusion criteria

Age < 18 years.

Pregnancy.

Life expectancy < 1 year, or poor functional status (NYHA functional class IV).

Other concomitant structural heart diseases (e.g., congenital, non-ischemic, etc.)

Previously documented sustained ventricular arrhythmias.

Impossibility or contraindications for performing both a contrast-enhanced CMR and a cardiac CT scan.

Concomitant investigational treatments.

Clinical assessment of the usefulness of new obstructive sleep apnea detection technologies in patients scheduled for atrial fibrillation ablation.

Inclusion criteria:

· Patients with paroxysmal or persistent atrial fibrillation scheduled for a first pulmonary vein ablation procedure.

· Patients over 18 years of age and under 70 years of age.

· Patients capable of correctly using the device and following the technical instructions required in the protocol.

· Patients with the ability to understand and offer written informed consent.

Exclusion criteria:

· Patients with already diagnosed obstructive sleep apnea.

· Patients with implantable electronic devices.

· Patients with previous pulmonary vein ablation.

· Patients with moderate or severe mitral or aortic valve disease.

· Patients with valve prostheses.

· Patients with severe dilation of the left atrium.

· Allergy to device adhesive

· Anatomical conditions (e.g. extremely lax skin on the neck) that prevent correct placement of the device.

· Functional class III-IV of the classification of heart failure, recent myocardial infarction or stroke (>3 months), cancer treated with chemotherapy, dialysis, or any other comorbidity that could affect adjustment to the protocol.

 

Wants to compare an oral factor XIa inhibitor (milvexian) with Apixaban in prevention of strokes and systemic embolisms outside the central nervous system in subjects with Atrial Fibrillation.

Inclusion criteria

Medically stable

Atrial fibrillation or flutter, paroxysmal or sustained not due to a reversible cause, and eligible for anticoagulant therapy:

The participant must meet one or both of the following risk factor categories

to. One or more of the following risk factors:

Yo. Age ≥75 years at the time of selection

ii. History of a symptomatic clinical stroke of any type (ischemic, hemorrhagic, lacunar or undetermined), including silent cerebral infarcts and cerebral microbleeds (CMB):

The ischemic stroke must be > 7 days before the first dose of the study intervention. Hemorrhagic strokes and hemorrhagic transformations must have occurred ≥3 months previously and are permitted by investigator discretion. A prior neurology consultation is recommended to check if the patient is appropriate for anticoagulation.

Exclusion criteria

-MI secondary to ischemia due to increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index event of ACS.

-Minimal or no obstructive CAD on angiography performed for the index event of ACS before any PCI

-Planned CABG or staged PCI after randomization.

– Any condition requiring chronic anticoagulation at the discretion of the investigator and/or local guidelines.

-Conditions with a significantly increased risk of bleeding (e.g., clinically significant bleeding in the last 3 months, known bleeding diathesis, etc.)

-Requires permanent dialysis or has an eGFR <15 ml/min/1,73 m2

– Current active liver disease

– Active cancer undergoing chemotherapy or radiation or immunotherapy treatment

– CABG performed during the index event

-History of ischemic stroke or TIA

– Killip Class 3 or 4 at the time of randomization

-History of any significant drug allergies

– Known allergies, hypersensitivity or intolerance to milvexian or its excipients

Apixaban for the Reduction of Thromboembolism in patients with Subclinical atrial fibrillation detected by a device. The purpose of this clinical trial was to determine which treatment is best for preventing stroke or systemic embolism in patients who have experienced at least one episode of atrial fibrillation detected by a device and who also have other risk factors for stroke.

Studied the behavior of edoxaban in non-valvular atrial fibrillation (NVAF) and heart failure (HF).