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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
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