Clinical Trials Logo
  1. Home
  2. Atrial Fibrillation
  3. NCT05710822
  4. Details
NCT05710822 Clinical Trial

QDOT Based PVI for Atrial Fibrillation Treatment - The peQasus Study

Atrial Fibrillation Clinical Trial

— peQasus  

Official title:
Very High-Power Short-duration Ablation Utilizing the QDOT Micro Ablation Catheter for Pulmonary Vein Isolation - A Multicenter Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05710822
Other study ID # peQasus study
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 31, 2023
Est. completion date June 30, 2023

Study information
Verified date January 2023
Source University of Luebeck
Contact Christian-Hendrik Heeger, MD
Phone 004945150075293
Email christian.heeger@gmx.net
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

PeQasus is a worldwide, retrospective, multicenter analysis focusing on QDOT based PVI. Data of at least 300 patients with QDOT based PVI will be collected. All data will be evaluated after anonymization. Primary endoints are efficacy and safety.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Suitable for PVI Exclusion Criteria: - Non suitable for PVI

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• pulmonary vein isolation
pulmonary vein isolation utilizing the QDOT Micro ablation catheter

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Luebeck

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of the procedure Acute PVI Periprocedural
Primary Saftey (Cardiac tamponade) Periprocedural complications (occurence of cardiac tamponade) Periprocedural
Primary Safety (Stroke) Periprocedural complications (occurence of stroke) Periprocedural
Primary Safety (Bleeding) Periprocedural complications (occurence of puncture site bleeding) Periprocedural
Secondary Procedure time Periprocedural
Secondary LA dwelling time Periprocedural
Secondary First pass isolation Periprocedural
Secondary 12 months follow-up Occurence of aftrial fibrillation or atrial tachycardia >30 Seconds between 91 days and 12 months of follow-up 91 days - 12 months after the procedure
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A