NCT05959798

Brief Summary

High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

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

April 20, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

4.2 years

First QC Date

July 17, 2023

Last Update Submit

July 17, 2023

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of reconnected pulmonary veins 20 minutes after ablation in comparison of both ablation groups

    Acute endpoint

Secondary Outcomes (1)

  • Time to first documented recurrence of atrial fibrillation after a 6-week blanking period.

    12 months after ablation

Study Arms (2)

High power short duration ablation

Procedure: High power short duration ablation

Moderate power long duration ablation

Procedure: High power short duration ablation

Interventions

High power short duration ablationPROCEDURE

Pulmonary vein isolation by high power short duration radiofrequency catheter ablation

High power short duration ablationModerate power long duration ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with documented paroxysmal atrial fibrillation, not previously treated by left atrial catheter ablation

You may qualify if:

  • symptomatic, documented, drug-resistent paroxysmal atrial fibrillation
  • effective oral anticoagulation

You may not qualify if:

  • any prior left atrial ablation procedure
  • presence of left atrial thrombus
  • secondary atrial fibrillation due to electrolyte imbalance or thyroid disease
  • any prior oesophageal or gastric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

München, 80636, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isabel Deisenhofer, Prof. Dr.

    Deutsches Herzzentrum München, Abt. für Elektrophysiologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

April 20, 2019

Primary Completion

July 17, 2023

Study Completion

July 17, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)