QDOT Based PVI for Atrial Fibrillation Treatment - The peQasus Study (peQasus)

January 25, 2023 updated by: Christian-H. Heeger, MD, University of Luebeck

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Afib patients with indication to pulmonary vein isolation

Description

Inclusion Criteria:

  • Suitable for PVI

Exclusion Criteria:

  • Non suitable for PVI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the procedure
Time Frame: Periprocedural
Acute PVI
Periprocedural
Saftey (Cardiac tamponade)
Time Frame: Periprocedural
Periprocedural complications (occurence of cardiac tamponade)
Periprocedural
Safety (Stroke)
Time Frame: Periprocedural
Periprocedural complications (occurence of stroke)
Periprocedural
Safety (Bleeding)
Time Frame: Periprocedural
Periprocedural complications (occurence of puncture site bleeding)
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: Periprocedural
Periprocedural
LA dwelling time
Time Frame: Periprocedural
Periprocedural
First pass isolation
Time Frame: Periprocedural
Periprocedural
12 months follow-up
Time Frame: 91 days - 12 months after the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Investigators

  • Principal Investigator: Christian-Hendrik Heeger, MD, Department of Rhythmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 31, 2023

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • peQasus study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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