NCT05251545

Brief Summary

The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) varies between 80 and 90 %. This prospective, randomized study investigated the efficacy of pulmonary vein isolation with RF-energy following the CLOSE protocol with standard energy application (30 Watts) versus PVI with RF-energy with high power settings (45 Watts).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

January 4, 2022

Last Update Submit

August 1, 2025

Conditions

Atrial Fibrillation ParoxysmalCatheter Ablation

Outcome Measures

Primary Outcomes (1)

  • Single procedure success rate, identified by 48-hours Holder-ECGs every three months

    Freedom of any atrial arrhythmia of more than 30 sec during a follow-up period of 12 months after the first procedure.

    1 year

Secondary Outcomes (1)

  • Procedural data

    1 year

Study Arms (2)

High power - short duration

ACTIVE COMPARATOR

Pulmonary vein isolation with high power settings of 45 Watts

Other: Pulmonary vein isolation

Standard energy

ACTIVE COMPARATOR

Pulmonary vein isolation with standard power settings (30 Watts)

Other: Pulmonary vein isolation

Interventions

Pulmonary vein isolationOTHER

Comparison of power levels in catheter ablation in regard of single procedure success rate (freedom of any atrial arrhythmia with a duration of more than 30 sec. 45 Watts versus standard power levels (30 Watts).

High power - short durationStandard energy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Paroxysmal atrial fibrillation
  • written informed consent

You may not qualify if:

  • inability to obtain written informed consent
  • persistent atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Bosch Medical Center

Stuttgart, 70376, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Ong, Prof

    Robert Bosch Medical Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist (in German: Oberarzt)

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 22, 2022

Study Start

September 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)