Clinical trials: Pacemaker Syndrome
Sinus Node Dysfunction, Sick Sinus Syndrome
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a…
- Trial name
- DINERVAPACE (NCT05186220)
- Testing
- Cardioneuroablation, Permanent dual chamber pacemaker implantation
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Hospital Clinico Universitario de Santiago
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing single-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
- Trial name
- ZF-PMSC (NCT03118440)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block (Disorder), Bradycardia
- Trial name
- ZF-PMDC (NCT03118427)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
Blood Pressure
Long-term Atrial Pacing and Central Blood Pressure
This is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are…
- Trial name
- NCT04309175
- Testing
- base rate programming of a permanent cardiac pacemaker
- Volunteers
- 58 people
- Sponsor
- Tartu University Hospital
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
Cardioneuroablation, Permanent Pacemaker Implantation
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
Different studies for cardiac ganglionated plexus（GP） ablation to treat vagal vascular syncope, sinus node dysfunction, and functional atrioventricular block have been published.
- Conditions
- Cardioneuroablation, Permanent Pacemaker Implantation, Sick Sinus Syndrome, Ganglionated Plexus
- Trial name
- GAPS (NCT04149886)
- Testing
- cardiac ganglion plexus ablation(cardioneuroablation), Permanent pacemaker implantation
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- China National Center for Cardiovascular Diseases
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Sinus Node Disease
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence…
- Trial name
- B3 (NCT02579889)
- Testing
- DDD+CLS, DDD(R)
- Where
- 54 sites in China, Hungary and 7 more
- Volunteers
- 1,390 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
Atrial Fibrillation, Sick Sinus Syndrome
PACE-AF: Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation
PACE-AF is a prospective, observational patient registry designed to evaluate the impact of pacemaker algorithms on atrial fibrillation (AF) incidence, progression, and clinical outcomes in patients implanted with dual-chamber…
- Conditions
- Atrial Fibrillation, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- PACE-AF (NCT07279207)
- Where
- Russia
- Volunteers
- 500 people
- Sponsor
- Ilya Lukin
Bradycardia, Heart Block
Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers
This study is a prospective, single-arm, single-center feasibility study evaluating the safety and feasibility of transjugular (internal jugular vein) implantation of the Aveir VR leadless ventricular pacemaker in patients…
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- Trial name
- NCT07802119
- Testing
- Aveir VR Leadless Pacemaker
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Min Shen
Aortic Blood Pressure
The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
This study is divided into two parts: The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac…
- Trial name
- NCT03245996
- Testing
- AAI 40 bpm, AAI 60 bpm, AAI 90 bpm
- Volunteers
- 27 people
- Sponsor
- Tartu University Hospital
Sick Sinus Syndrome
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
- Trial name
- NCT00161538
- Testing
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Where
- 12 sites in Germany
- Volunteers
- 456 people
- Sponsor
- Medtronic BRC
Atrioventricular Synchrony by the Micra AV
French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous…
- Trial name
- AV-CESAR (NCT05953558)
- Testing
- Patients implanted with Micra AV
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Paris Sudden Death Expertise Center
Bradycardia, Brady-tachy Syndrome
ALPs Single ChambEr New Device
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Bradycardia, Brady-tachy Syndrome, AV Block, Atrial Fibrillation (AF)
- Trial name
- ASCEND (NCT07461935)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 10 people
- Sponsor
- Cairdac SA
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Arrhythmia, Sinus
EnTRINSIC - EnPulse Trial on Search AV+ Influence
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction.
- Trial name
- NCT00157794
- Testing
- Search AV+ algorithm
- Where
- 14 sites in Germany
- Volunteers
- 135 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sinus Node Disease, Atrioventricular Block
BIO|STREAM.CSP CLS
This clinical study is a prospective, observational submodule of the BIO|STREAM.CSP registry designed to evaluate clinical outcomes in patients receiving BIOTRONIK dual-chamber pacemakers that combine conduction system…
- Trial name
- NCT07608822
- Testing
- Left bundle branch area pacing with Closed Loop Stimulation
- Where
- 12 sites in Czechia, Hungary and 3 more
- Volunteers
- 150 people
- Sponsor
- Biotronik SE & Co. KG
Periodic Breathing
Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.
To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.
- Trial name
- NCT01044407
- Testing
- Pacemaker manipulation
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Imperial College London
Bradycardia; Sick Sinus Syndrome, AV Block
Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
- Trial name
- NCT00156741
- Testing
- Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2, Required pacemaker setting
- Where
- 30 sites in Austria, Czechia and 9 more
- Volunteers
- 150 people
- Sponsor
- Medtronic BRC