Clinical trials: PVI
Surgery
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices.
- Trial name
- NCT02841397
- Testing
- Masimo Pulse CO-Oximeter
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Masimo Corporation
Persistent Atrial Fibrillation
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in…
- Trial name
- NCT07106970
- Testing
- Linear ablation, PVI alone
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF)
COCONUT Study Concomitant PVI and LAAC
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and…
- Trial name
- COCONUT (NCT06861673)
- Testing
- Pulmonary vein isolation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Asklepios proresearch
Atrial Fibrillation
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with…
- Trial name
- PAVANE (NCT01276093)
- Testing
- PVI ablation, Amiodarone
- Where
- 6 sites in Netherlands
- Volunteers
- 59 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Interventions
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions.
- Trial name
- ACCESS-PVI (NCT06141694)
- Testing
- The LIBERTY® Robotic System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Microbot Medical, INC
Atrial Fibrillation
Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.
DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI)…
- Trial name
- DISPLAY-AF (NCT07807423)
- Testing
- Complete biatrial mapping
- Where
- 5 sites in France
- Volunteers
- 125 people
- Sponsor
- Volta Medical
Peripheral Artery Disease
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
- Trial name
- REACH PVI (NCT03943160)
- Testing
- Diamondback 360 Extended Length Orbital Atherectomy System
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
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
Atrial Fibrillation
Persistent AF Catheter Ablation: Re-PVI Vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM
Major objective is to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients…
- Trial name
- AF-CAM (NCT05496088)
- Testing
- Re-PVI only, Re-PVI + substrate ablation
- Where
- 3 sites in Germany
- Volunteers
- 56 people
- Sponsor
- Asklepios proresearch
Peripheral Arterial Disease
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease
This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.
- Trial name
- RAPID (NCT02371785)
- Testing
- CorPath 200 System
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
Atrial Fibrillation
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an…
- Trial name
- aMAZE (NCT02513797)
- Testing
- LARIAT + PVI, Pulmonary Vein Isolation
- Where
- 53 sites in United States
- Volunteers
- 600 people
- Sponsor
- AtriCure, Inc.
Anesthesia, General, Fluid Therapy
Management of Intraoperative Fluids in Ambulatory Surgery
This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the…
- Conditions
- Anesthesia, General, Fluid Therapy, Ambulatory Surgical Procedures
- Trial name
- MIFAS (NCT03193320)
- Testing
- Fluid therapy protocol
- Where
- Venezuela
- Volunteers
- 243 people, healthy volunteers welcome
- Sponsor
- Policlinica Metropolitana
Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System
P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization.
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial Fibrillation (Paroxysmal), Pulmonary Vein Isolation
- Trial name
- FOLLOW-AF (NCT07471308)
- Testing
- AF Recurrence RIsk Assessment post pulmonary vein isolation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- CathVision ApS
Atrial Fibrillation
Sole-Therapy Treatment of Atrial Fibrillation
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not…
- Trial name
- RESTORE SR II (NCT00566176)
- Testing
- Surgical Ablation using the AtriCure Bipolar System
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- AtriCure, Inc.
Paroxysmal Atrial Fibrillation
The FARAPULSE FARA-Freedom Trial
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed…
- Trial name
- FARA-Freedom (NCT05072964)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 13 sites in Belgium, Czechia and 4 more
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal.
- Trial name
- NCT03624881
- Testing
- Catheter ablation with EPU
- Where
- 41 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
SOLAR & ATRILAZE Atrial Fibrillation Trial
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
- Trial name
- SAAF-T (NCT00734058)
- Testing
- Laser MAZE by Ablation of Cardiac Tissue
- Volunteers
- 90 people
- Sponsor
- EndoPhotonix, Inc.
Persistent Atrial Fibrillation, Heart Failure
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D…
- Conditions
- Persistent Atrial Fibrillation, Heart Failure, ICD
- Trial name
- AMICA (NCT00652522)
- Testing
- ICD/CRT implant, AF ablation, Best Medical Treatment
- Where
- 16 sites in Germany, Hungary and 1 more
- Volunteers
- 202 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of…
- Trial name
- HeartLight (NCT01456000)
- Testing
- EAS-AC (HeartLight), Control Arm Ablation
- Where
- 21 sites in United States
- Volunteers
- 405 people
- Sponsor
- CardioFocus
Paroxysmal Atrial Fibrillation
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial…
- Trial name
- FIRMAP-AF (NCT02703454)
- Testing
- FIRM-guided RF ablation, Conventional RF ablation
- Where
- Germany
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices