Clinical trials: Reflex Syncope
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Arhythmia, Atrioventricular Heart-block
Observation of ImageReady™ MR Conditional Pacing System in China
To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects
- Conditions
- Arhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction Syndrome
- Trial name
- NCT02636712
- Testing
- ImageReady™ MR Conditional Pacing System
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Syncope
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences.
- Trial name
- BIOSync CLS (NCT02324920)
- Testing
- DDD-CLS, ODO
- Where
- 24 sites in Canada, France and 4 more
- Volunteers
- 128 people
- Sponsor
- Biotronik SE & Co. KG
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
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices
Orthostatic Hypotension, Reflex Syncope
Data Collection - Of Syncope Tilt Table Testing Study
To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.
- Trial name
- COST3 (NCT03721393)
- Testing
- Wearable heart monitor
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Syncope
ISSUE3: International Study on Syncope of Uncertain Etiology 3
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.
- Trial name
- NCT00359203
- Testing
- Dual chamber pacemeker
- Where
- Italy
- Volunteers
- 511 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Orthostatic Hypotension, Reflex Syncope
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
To characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting.
- Trial name
- ARISE (NCT07502599)
- Testing
- Wearable holter monitor
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Vasovagal Syncope
Syncope Prediction Study
The purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one center in the United Kingdom.
- Trial name
- SPS (NCT02140567)
- Where
- United Kingdom
- Volunteers
- 140 people
- Sponsor
- Medtronic BRC
Syncope, Syncope, Vasovagal
Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pacing.
- Trial name
- BIO|Sync-HUTT (NCT06038708)
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Biotronik SE & Co. KG