NCT03332862

Brief Summary

Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

November 1, 2017

Last Update Submit

November 1, 2017

Conditions

Keywords

Catheter AblationAtrial FibrillationContact ForceContinuous Ablation

Outcome Measures

Primary Outcomes (1)

  • Combined unsuccessful PVI or PV reconnection

    Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time

    30 min after ablation

Secondary Outcomes (1)

  • Early pulmunary veins reconnection

    10 min.

Study Arms (2)

Discontinuous ablation

EXPERIMENTAL

perform discontinuous ablation of ipsilateral pulmunary veins.

Procedure: catheter ablation

Continuous ablation

ACTIVE COMPARATOR

perform continuous ablation of ipsilateral pulmunary veins.

Procedure: catheter ablation

Interventions

catheter ablation for atrial fibrillation treatment

Continuous ablationDiscontinuous ablation

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Czechia

RECRUITING

Related Publications (1)

  • Aldhoon B, Peichl P, Osmancik P, Konecny P, Kautzner J, Wichterle D. Acute efficacy of contiguous versus temporally discontiguous point-by-point radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation: a randomized study. J Interv Card Electrophysiol. 2022 Sep;64(3):661-667. doi: 10.1007/s10840-021-01113-9. Epub 2022 Jan 6.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Bashar Aldhoon, MD, PhD

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bashar Aldhoon, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Bashar Aldhoon, PhD

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

September 15, 2017

Primary Completion

December 31, 2017

Study Completion

January 31, 2018

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations