NCT02655731

Brief Summary

Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA. The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

December 23, 2015

Last Update Submit

August 12, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Freedom from atrial fibrillation and atrial tachyarrhythmias

    72h Holter-ECG recordings will be performed. In case of clinical arrhythmia symptoms event-recording will be provided.

    12 months

Study Arms (1)

Treatment

OTHER

PVI with HeartLight

Device: PVI with HeartLight

Interventions

PVI with HeartLightDEVICE

Catheter ablation

Treatment

Eligibility Criteria

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

You may qualify if:

  • Symptomatic atrial fibrillation
  • Left atrial size \<50mm
  • Left ventricular ejection fraction \<45%
  • Patient is able to provide informed consent

You may not qualify if:

  • Contraindications for PVI
  • Previous PVI attempts
  • Inability to be treated with oral anticoagulation
  • Presence of intracardiac thrombi
  • Pregnancy
  • Participation in other clinical studies
  • Unwilling to follow the study protocol and to attend follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, 60431, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Boris Schmidt, MD

    Cardioangiologisches Centrum Bethanien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

December 23, 2015

First Posted

January 14, 2016

Study Start

December 1, 2015

Primary Completion

March 20, 2018

Study Completion

March 20, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

DE(1)