Clinical trials: Pacemaker Indication
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Surgical Procedures
Placement of Permanent Pacemaker Study
The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for…
- Trial name
- NCT00512161
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Weill Medical College of Cornell University
Pacemaker Indication
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and…
- Trial name
- NCT00916344
- Testing
- EVIA Pacemaker
- Where
- France
- Volunteers
- 175 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Bradycardia
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure. Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart…
- Trial name
- OPTPACE-HF (NCT07563153)
- Testing
- Adjustment of the pacemaker/ICDs lower rate limit (LRL), Conventional lower rate (60bpm)
- Where
- South Korea
- Volunteers
- 106 people
- Sponsor
- Samsung Medical Center
Pacemaker Indication
Ventricular Pace Suppression Study
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
- Trial name
- VpS (NCT01053832)
- Testing
- VpS algorithm in EVIA and ENTOVIS pacemakers
- Where
- 2 sites in Germany
- Volunteers
- 84 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure
In this study we will select twenty patients with chronic atrial fibrillation and ventricular dysfunction with permanent cardiac pacemaker indication.
- Trial name
- NCT02186314
- Testing
- Pacemaker Biotronik: apical stimulation, Pacemaker Biotronik: bifocal stimulation
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Aortic Valve Stenosis
Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI
The current observational registry aims to evaluate in patients undergoing TAVI implantation: 1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure, 2.
- Trial name
- PACE-TAVI (NCT05278585)
- Testing
- RAP TAVI
- Where
- 12 sites in Belgium
- Volunteers
- 500 people
- Sponsor
- AZ Sint-Jan AV
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles
Indications for VVI(R) Pacemaker
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
- Trial name
- NCT02051972
- Testing
- Implanted with a Nanostim leadless pacemaker system
- Where
- 32 sites in Czechia, France and 5 more
- Volunteers
- 491 people
- Sponsor
- Abbott Medical Devices
Indication for Cardiac Resynchronization Therapy (CRT)
Evia/Entovis HF-T Master Study
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers.
- Trial name
- NCT01545739
- Testing
- Evia/Entovis HF-T pacemaker for CRT therapy
- Where
- Hungary
- Volunteers
- 122 people
- Sponsor
- Biotronik SE & Co. KG
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
- Trial name
- OPTI-MIND 2 (NCT01715558)
- Where
- 39 sites in Belgium, Denmark and 7 more
- Volunteers
- 514 people
- Sponsor
- Boston Scientific Corporation
Sinus Arrhythmia, Atrial Fibrillation
Electrophysiologically Guided PAcing Site Selection Study
This study is a long-term, prospective, and controlled evaluation of the incidence of persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction delay paced with preventive algorithms at the…
- Trial name
- EPASS (NCT00239226)
- Testing
- IAS pacing - study group, IAS pacing control group, Pacing RAA study group
- Where
- 8 sites in Italy
- Volunteers
- 102 people
- Sponsor
- Medtronic BRC
Hypertension, Atrial Fibrillation
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.
- Trial name
- NCT00256152
- Testing
- AF Suppression Pacing Algorithm
- Where
- Canada
- Volunteers
- 2,580 people
- Sponsor
- Abbott Medical Devices
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Micra Transcatheter Pacing Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
- Trial name
- NCT02004873
- Testing
- Micra Pacemaker Implant
- Where
- 56 sites in United States, Australia and 17 more
- Volunteers
- 744 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacing Indication classI/IIa According AHA/ACC
Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.
- Trial name
- Prevent-HF (NCT00170326)
- Testing
- dual-chamber pacemaker implantation, biventricular dual-chamber pacemaker implant
- Where
- 5 sites in Spain
- Volunteers
- 108 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.
- Trial name
- OPTI-MIND (NCT00976482)
- Where
- Germany
- Volunteers
- 1,745 people
- Sponsor
- Boston Scientific Corporation
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
Sinus Node Dysfunction
A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction
Providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living.
- Trial name
- CRIPS (NCT02027909)
- Testing
- Reprogramming dual chamber pacemaker
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Arun Rao
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
- Trial name
- ANSWER (NCT00562107)
- Testing
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Where
- 37 sites in United States, France and 4 more
- Volunteers
- 650 people
- Sponsor
- LivaNova
Intracardiac Thrombus, Intracardiac Mass
AngioVac Aspiration Therapy Registry
As a structured, multinational retrospective registry the AVATAR Registry addresses the following scientific aspects through systematic data collection, centralized quality control, and robust statistical analysis in patients…
- Conditions
- Intracardiac Thrombus, Intracardiac Mass, Intravascular Thrombosis, Vegetation; Heart
- Trial name
- AVATaR (NCT07769320)
- Testing
- Retrospective analysis of assigned treatment
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Charite University, Berlin, Germany