Clinical trials: Sinus Rhythm
Atrial Fibrillation, Atrial Flutter
American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm
To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).
- Trial name
- ADONIS (NCT00259376)
- Testing
- Dronedarone (SR33589)
- Where
- 5 sites in United States, Argentina and 3 more
- Volunteers
- 629 people
- Sponsor
- Sanofi
Atrial Fibrillation, Atrial Flutter
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.
- Trial name
- NCT00126074
- Testing
- Tedisamil sesquifumarate
- Where
- 26 sites in United States, Bulgaria and 4 more
- Sponsor
- Solvay Pharmaceuticals
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.
- Trial name
- NCT00540787
- Testing
- Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs, ThermoCool Radiofrequency Catheter
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 112 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)
This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in…
- Trial name
- PROMISE-AF (NCT03906799)
- Testing
- OMT-28
- Where
- 25 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 136 people
- Sponsor
- Omeicos Therapeutics GmbH
Paroxysmal Atrial Fibrillation
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients…
- Trial name
- RESTORE-1 (NCT05039359)
- Testing
- FlecIH-103
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 54 people
- Sponsor
- InCarda Therapeutics, Inc.
Atrial Fibrillation
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
- Trial name
- TUNDRA-AF (NCT01259622)
- Testing
- saline, K201
- Where
- 17 sites in Denmark, Israel
- Volunteers
- 80 people
- Sponsor
- Sequel Pharmaceuticals, Inc
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the…
- Trial name
- RHYTHM-AF (NCT01119716)
- Volunteers
- 4,658 people
- Sponsor
- Merck Sharp & Dohme LLC
Heart Failure, Atrial Arrhythmia
Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268294
- Testing
- Cardiac Resynchronization Therapy
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
- Trial name
- RESTORATION (NCT00626652)
- Testing
- K201 Injection
- Where
- 9 sites in Israel, Russia
- Volunteers
- 153 people
- Sponsor
- Sequel Pharmaceuticals, Inc
Paroxysmal Atrial Fibrillation (PAF)
INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
The study consisted of 3 parts (Part A, Part B and Part C). Part A was an open-label, randomized, multi center design to evaluate the feasibility of administration of inhaled flecainide in two dosing regimens.
- Trial name
- INSTANT (NCT03539302)
- Testing
- Flecainide Acetate
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 176 people
- Sponsor
- InCarda Therapeutics, Inc.
Atrial Fibrillation
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
- Trial name
- DIONYSOS (NCT00489736)
- Testing
- dronedarone (SR33589), amiodarone
- Where
- 23 sites in United States, Argentina and 21 more
- Volunteers
- 504 people
- Sponsor
- Sanofi
Heart Failure, Cardiomyopathy
Clinical Evaluation on Advanced Resynchronization
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
- Trial name
- NCT00658203
- Testing
- New Living CHF
- Where
- 36 sites in France, Germany and 4 more
- Volunteers
- 310 people
- Sponsor
- LivaNova
Heart Failure NYHA Class III and Ambulatory IV
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization…
- Trial name
- RESPOND-CRT (NCT01534234)
- Testing
- PARADYM RF SONR
- Where
- 125 sites in United States, Australia and 10 more
- Volunteers
- 1,039 people
- Sponsor
- MicroPort CRM
Atrial Fibrillation, Atrial Flutter
Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter
Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.
- Trial name
- MAIA (NCT00233441)
- Testing
- CELIVARONE (SSR149744C)
- Where
- 17 sites in United States, Argentina and 15 more
- Volunteers
- 673 people
- Sponsor
- Sanofi
Sick Sinus Syndrome
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace…
- Trial name
- VIPERS (NCT01528657)
- Testing
- Ventricular Pace Suppression (Vps), Intrinsic rhythm support (IRSplus)
- Where
- 20 sites in Italy
- Volunteers
- 230 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation or Flutter
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
LGN-VN-003 is a prospective, 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…
- Trial name
- RESTORE SR (NCT02454283)
- Testing
- Vanoxerine HCl
- Where
- 16 sites in United States, Bulgaria and 3 more
- Volunteers
- 41 people
- Sponsor
- Laguna Pharmaceuticals, Inc.
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using…
- Trial name
- AGILIS (NCT00469638)
- Testing
- Left atrial catheter ablation guided by introducer using Agilis sheeth, Left atrial catheter ablation guided by introducer using Non-steerable sheeth
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- Abbott Medical Devices