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An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention - PIONEER AF-PCI

In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.

A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting

See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…

The PACE NOW Trial: A Prospective, rAndomized Comparison of tEmporary transvenous pacing and leadless paciNg therapy in pOst-TAVI patients With conduction abnormalities

The primary objective of the study is to outline the advantages of LP implantation in TAVI patients who require temporary, and possibly permanent pacing compared to the Standard of Care using TV-TP therapy. We will study whether placement of a LP…

Multi-electrode PulmonarY Vein isolation vs Single Tip wide area Catheter ablation for Paroxysmal Atrial Fibrillation

Purpose is to show that multi-electrode ablation is not inferior to irrigated single tip catheter ablation guided by 3-D mapping to treat paroxysmal atrial fibrillation.

Protocol CV185030: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

Primary objective: To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at lease one additional risk factor for…

A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)

The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…

Ingenio Device Algorithm Study

To gather data to support global submissions/approvals for some models of the Ingenio device family.

A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once-Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients with an Implantable Cardioverter Defibrillator

This study (AZM-MD-302) will be undertaken to confirm the effectiveness of aonce-daily oral dose of 75 mg azimilide on the reduction of unplanned cardiovascular emergencydepartment visits and hospitalizations or cardiovascular death in patients with…

European Health Economic Trial on home monitoring in ICD and CRT-D patients

This amendment (extension to CRT-D subjects) aims to assess the economic effects of HM technology vs. classical follow-up of CRT-D patients from two perspectives: 1) the cost-effectiveness for the payer of health care, and 2) the economic impact on…

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A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation

The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The…

A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors

The primary objective of this trial is to demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular…

Randomized double blind trial to evaluate the efficacy and safety of dronedarone (400 mg BID) versus amiodarone (600 mg daily for 28 days then 200 mg daily thereafter) for at least 6 months for the maintenance of sinus rhythm in patients with atrial fibrillation (AF)

To demonstrate that dronedarone is superior to amiodarone in the maintenance of sinus rhythm after pharmacological, electrical or spontaneous conversion of AF.

EFFICACY OF VERNAKALANT IN THE CONVERSION OF ATRIAL FIBRILLATION IN CRITICAL ILLNESS

Primary objective:Investigate the efficacy and safety of Vernakalant in the acute conversion of AF, as compared to Amiodarone and rate control alone, in critically ill patients admitted to the medical and non-cardiac surgical ICU.Secondary objective…

A multi-center, Randomized, double-blind, placebo-controlled study to Evaluate the Safety and efficacy of a single oral dose of vanoxerine for The conversion Of subjects with REcent onset atrial fibrillation or flutter to normal Sinus Rhythm

To evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm.

Utilizing Novel dipole density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)

The objective of the clinical study is to evaluate the incidence of device- and procedure-related safety, efficacy, and efficiency (6-and 12-month outcomes) when using the AcQMap as an imaging and mapping system for ablation of persistent atrial…

TAME Cardiac Arrest Trial. Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial

The primary objective of this study is to determine whether targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN).

A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLINDED ENDPOINT EVALUATION (PROBE) PARALLEL GROUP STUDY COMPARING EDOXABAN VS. VKA IN SUBJECTS UNDERGOING CATHETER ABLATION OF NON-VALVULAR ATRIAL FIBRILLATION

Primary efficacy objective:To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and MajorBleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the…

Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist- based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement (ENTRUST_AF PCI)

The primary objective is to compare a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12…

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia;The RAPID Study (NODE-301 Part 2)

The primary objective of the RAPID study is to determine whether etripamil nasal spray (NS) self-administered by patients is superior to placebo at terminating episodes of PSVT in an at-home setting.The secondary objective of this study is to…