NCT05710822

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 17, 2023

Last Update Submit

January 25, 2023

Conditions

Atrial Fibrillation

Keywords

Catheter abaltion, very high-power short-duration, QDOT

Outcome Measures

Primary Outcomes (4)

  • Efficacy of the procedure

    Acute PVI

    Periprocedural

  • Saftey (Cardiac tamponade)

    Periprocedural complications (occurence of cardiac tamponade)

    Periprocedural

  • Safety (Stroke)

    Periprocedural complications (occurence of stroke)

    Periprocedural

  • Safety (Bleeding)

    Periprocedural complications (occurence of puncture site bleeding)

    Periprocedural

Secondary Outcomes (4)

  • Procedure time

    Periprocedural

  • LA dwelling time

    Periprocedural

  • First pass isolation

    Periprocedural

  • 12 months follow-up

    91 days - 12 months after the procedure

Interventions

pulmonary vein isolationDEVICE

pulmonary vein isolation utilizing the QDOT Micro ablation catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Afib patients with indication to pulmonary vein isolation

You may qualify if:

  • Suitable for PVI

You may not qualify if:

  • Non suitable for PVI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian-Hendrik Heeger, MD

    Department of Rhythmology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian-Hendrik Heeger, MD

CONTACT

004945150075293christian.heeger@gmx.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 2, 2023

Study Start

January 31, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01