Clinical trials: PVI
Atrial Fibrillation
Serial Hybrid Atrial Fibrillation Ablation
Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective.
- Trial name
- SHAFT (NCT01582828)
- Testing
- Epicardial (surgical) ablation, Hybrid
- Where
- Netherlands
- Sponsor
- Medisch Spectrum Twente
Fluid Imbalance
Comparing Pleth Variability Index (PVI) Measurements at Different Sensing Locations
The purpose of this study is to assess the suitability of the ear and forehead as a better site for measure of fluid responsiveness.
- Trial name
- NCT02124551
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of California, Irvine
Fluid Response
Pleth Variability Index for Directed Fluid Optimization in Donors in Living Donor Liver Transplantation
In this Study we are trying to validate the accuracy of Plethogram variability index in predicting fluid responsiveness compared to pulse pressure variation in donors of liver transplantation
- Trial name
- NCT03921125
- Testing
- Massimo for Pleth variability index
- Where
- 2 sites in Egypt
- Volunteers
- 40 people
- Sponsor
- Ain Shams University
Atrial Fibrillation Recurrent
Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF
Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA).
- Trial name
- REPEAT-AF (NCT06199180)
- Testing
- pulmonary vein isolation with RFA, pulmonary vein isolation with PFA
- Where
- Netherlands
- Volunteers
- 154 people
- Sponsor
- University Medical Center Groningen
Assessment of Safety of Laser Balloon Ablation, Assessment of Procedural Times of Laser Ballon Ablation
Single-Laser PVI: Single-encirclement Laserballoon Ablation for Pulmonary Veins Isolation
To assess the efficacy of laser balloon ablation of atrial fibrillation (AF) without verification of electrical isolation of pulmonary veins using implantable loop recorder. This is a prospective and single-center study.
- Trial name
- SingleLaser (NCT04165642)
- Testing
- Laser ballon ablation for Pulmonary vein isolation
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- IRCCS Policlinico S. Donato
Mitral Regurgitation
Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Transcatheter mitral valve repair in the form of MitraClip® is a safe and effective alternative to surgical mitral valve repair/replacement in patients with high operative morbidity and mortality risk.
- Trial name
- NCT03993938
- Testing
- PVI measurement
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Henry Ford Health System
Atrial Fibrillation (AF), Bleeding
Concomitant PFA Bsaed PVI Plus LAAC
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy…
- Conditions
- Atrial Fibrillation (AF), Bleeding, Stroke
- Trial name
- COCONUT_2 (NCT07450755)
- Testing
- Interventional LAA Closure, Pulmonary vein isolation
- Volunteers
- 150 people
- Sponsor
- Asklepios proresearch
Peripheral Artery Disease
PREDICT-PVI Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention
The overall goal of this multicenter collaborative research study is to identify genetic, proteomic, and/or lipidic (lipidomic) biomarkers associated with the outcomes of lower extremity revascularization in patients with…
- Trial name
- NCT02180373
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- Vascular Cures
Atrial Arrhythmia
Relationship Between the Posterior Atrial Wall and the Esophagus: Esophageal Position and Temperature MEasurement During Atrial Fibrillation Ablation.
A multimodal strategy integrating esophageal visualization with the multidetector computed tomography (MDCT) and simultaneous temperature monitoring has never been put into practice.
- Trial name
- AWESOME-AF (NCT04394923)
- Testing
- Modification of the pulmonary vein ablation line, Regular PVI ablation
- Where
- Spain
- Volunteers
- 64 people
- Sponsor
- Centro Medico Teknon
Peripheral Arterial Disease
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).
- Trial name
- OMEGA-PVI (NCT02096757)
- Testing
- Pro-Omega
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, San Francisco
Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation
Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF
There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI).
- Trial name
- REPEAL-AF (NCT04506814)
- Testing
- Endocardial PVI, Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI
- Where
- United States
- Sponsor
- University of Rochester
Atrial Fibrillation
Comparison of Available Standard Pulse Field Ablation Methods for Pulmonary Vein Isolation for Treatment of Atrial Fibrillation
The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet…
- Trial name
- PVI-MODE (NCT07456540)
- Testing
- Pulse field ablation Systems
- Where
- Denmark
- Volunteers
- 1,125 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Paroxysmal Atrial Fibrillation
Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI.
- Trial name
- COMPARE-CRYO (NCT04704986)
- Testing
- PVI using the Arctic Front Cryoballoon (Medtronic), PVI using the PolarX Cryoballoon (Boston Scientific)
- Where
- 2 sites in Switzerland
- Volunteers
- 202 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Atrial Fibrillation, Risk Reduction
Prevention to Improve Outcomes After PVI
Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of…
- Conditions
- Atrial Fibrillation, Risk Reduction, Nurse's Role
- Trial name
- POP (NCT05148338)
- Testing
- Comprehensive risk factor treatment, Standard of care
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Atrial Fibrillation
Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or even superior alternatives to antiarrhythmic…
- Trial name
- VATCAT (NCT01319747)
- Testing
- PVI, VATS-PVI
- Where
- Netherlands
- Volunteers
- 77 people
- Sponsor
- Medisch Spectrum Twente
Intraoperative Monitoring
Intraoperative Pleth Variability Index (PVI) Variability
Pleth Variability Index (PVI) is a variable that is derived from photoplethysmography (PPG) signal. It is used as a surrogate for intravascular volume status intraoperatively.
- Trial name
- NCT03215238
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, San Francisco
Atrial Fibrillation
Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation.
Pulmonary vein isolation (PVI) is a proven, high-efficiency treatment for atrial fibrillation (AF). Performed, among others, using cryoablation, pulsed field ablation (PFA) or radiofrequency (RF) ablation.
- Trial name
- UNCOVER-PVI (NCT05677516)
- Testing
- ablation- pulmonary vain isolation- crioablation, ablation- pulmonary vain isolation- pulsed field ablation (PFA), ablation- pulmonary vain isolation- radiofrequency ablation (RF)
- Where
- 2 sites in Poland
- Volunteers
- 100 people
- Sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
Anesthesia Induced Hypotension, Hypotension Drug-Induced
Comparison of Pleth Variability Index vs. Diastolic Shock Index for Predicting Hypotension During Anesthesia Induction
This study aims to explore the frequent occurrence of hypotension during anesthesia induction due to anesthetic drugs or fasting. Predicting this condition is important for patient safety and anesthesia management.
- Trial name
- NCT06589674
- Testing
- Pulse variability index measurement, Diastolic shock index
- Where
- Turkey (Türkiye)
- Volunteers
- 126 people
- Sponsor
- Kocaeli City Hospital
Persistent Atrial Fibrillation, Catheter Ablation
Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown…
- Trial name
- PROMPT-AF (NCT04497376)
- Testing
- upgraded '2C3L', pulmonary vein antral isolation
- Where
- 12 sites in China
- Volunteers
- 498 people
- Sponsor
- Beijing Anzhen Hospital
Atrial Fibrillation, Recurrence
Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)
Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of…
- Trial name
- NCT04160117
- Testing
- Colchicine 0.6 mg
- Where
- Canada
- Volunteers
- 202 people
- Sponsor
- Population Health Research Institute