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PVAI alone vs. PVAI plus ablation of complex fractionated atrial electrograms in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation.

The aim of this study is to determine if adding ablation restricted to specific areas of the left atrium to PVAI is superior to the standard care PVAI alone.

A prospective, multi-center, post market randomized controlled trial comparing VT ablation outcomes using remote MAGNETIC navigation guided substrate mapping and ablation versus manual approach in a low LVEF population

To demonstrate that ventricular tachycardia (VT) ablation using the Niobe* ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.

A randomized comparison between 3 D CT overlay and conventional fluoroscopy to decrease contrast and radiation exposure during cryoballoon ablation for atrial fibrillation

This study will provide data on fluoroscopy exposure, use of contrast agents and effectiveness of the combined use of cryoballoon ablation and 3D CT overlay

Optimal Sensing in Atrial Tachyarrhythmia's Study

Verification of number of mode switches, Verification of undersensing of AFor other ATAs. Incidence of mode switches due to FFRW oversensing using Accent pacemaker in the most sensitive sensing setting(s)using the Optisense vrs Tendril lead

A prospective, randomized, multicenter, interventional study to evaluate the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation

Effectiveness: To provide valid scientific evidence that use of the TactiCath® Set is an effective treatment for symptomatic paroxysmal atrial fibrillation (PAF).Safety: To provide valid scientific evidence that use of the TactiCath® Set is safe as…

A FACT (Atrial Fibrillation ablation and AutonomiC modulation via Thoracoscopic Surgery). A randomized single center study to prospectively investigate the effect of ablation of the autonomic ganglia in addition to minimally invasive surgical isolation of the pulmonary veins in patients with atrial fibrillation.

This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal…

Shockless Implant Evaluation - A prospective Randomized Clinical Study

The trial will test the hypothesis that ICD implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.

MRI STUDY
ACCENT MRI* PACEMAKER AND TENDRIL MRI* LEAD IDE STUDY

The intent of this study is to evaluate the safety and efficacy of the implanted Accent MRI system, which includes the investigational St. Jude Medical Tendril MRI* lead and Accent MRI* pacemaker, in the MRI environment. An MRI Activator* will be…

Optimal Antitachycardia Therapy in ICD Patients without Pacing Indications

Primary study objective:The primary objective of this study is to evaluate the clinical outcome of dual-chamber ICD therapy with minimized ventricular pacing compared with single-chamber device therapy with settings which are common in clinical…

EUropean Pharmacogenetics of AntiCoagulant Therapy trial

To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with phenprocoumon compared to a dosing regimen that does not contain this genetic information.…

Catheter ablation versus Amiodarone to prevent future shock episodes in patients with a defibrillator and a history of a myocardial infarction.

The main objective of this study is to compare the occurrence of next ICD shock therapy for VT or VF in patients with hospital presentation for an ICD shock therapy for VT or VF, with a history of a myocardial infarction, between patients randomized…

EUropean Pharmacogenetics of AntiCoagulation Therapy trial

To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with acenocoumarol compared to a dosing regimen that does not contain this genetic information.…

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).

AMPLATZER* Amulet* Left Atrial Appendage (LAA) Occluder
Randomized Controlled Trial

This trial is intended to evaluate the safety and effectiveness of St. Jude Medical*s AMPLATZERTM AmuletTM device (Amulet) in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism. The trial will…

Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation with Focal Impulse and Rotor Modulation Guided Procedures (Redo-FIRM)

The primary objective is to evaluate the safety and effectiveness of FIRM-guided procedures in addition to conventional ablation for the treatment of persistent or paroxysmal atrial fibrillation (AF) in repeat ablation procedures.The secondary…

Assessment of the WATCHMAN TM Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)

The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN TM Left Atrial Appendage Closure (LAAC) Device including the post-implant medication regimen for subjects with non-valvular atrial fibrillation who are…

PVAC GOLD versus Irrigated RF single tip Catheter with Contact FORCE Ablation of the Pulmonary Veins for treatment of drug refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation

We hypothesize that PVAC GOLD is non-inferior to Single Tip catheter ablation with Contact Force sensor guided by 3-D mapping. This will be tested by comparing procedural characteristics and long term outcome with regard to safety, and effectiveness…

Tailored vs Anatomical Ablation Strategy for Persistent AF

In this study, our objective is to demonstrate that a tailored ablation strategy targeting areas exhibiting spatio-temporal dispersion in association with PVI, is superior to an anatomical probabilistic ablation strategy targeting PVI alone for the…

Accelerated Pacing for Improved Quality of Life in Symptomatic Atrial Fibrillation Patients undergoing Pace-and-Abate Strategy with Left Bundle Branch Area Pacing: a Randomized Controlled Pilot Trial: PACE-AF

To determine the effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergo-ing pace-and-ablate strategy with LBBAP.Secondary objectives: -…

Deliver mOre aPplications for more durable Pulmonary vein IsOlation with the Pentaspline Pulsed Field Ablation catheter, the DOPPIO trial

to determine if freedom of AF may be improved by delivering more, and targeted PFA applications while avoiding side-effects of higher PFA dosing.