NCT01863472

Brief Summary

Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
3 countries

6 active sites

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

First Submitted

Initial submission to the registry

May 19, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

May 19, 2013

Last Update Submit

November 18, 2016

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds

    between day 90 and 365 days after index procedure

Study Arms (2)

HeartLight(TM) Laser Balloon

ACTIVE COMPARATOR

Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation)

Device: HeartLight(TM) Laser Balloon

irrigated radiofrequency current ablation

ACTIVE COMPARATOR

Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation

Device: irrigated radiofrequency current ablation

Interventions

HeartLight(TM) Laser BalloonDEVICE

With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided

HeartLight(TM) Laser Balloon
irrigated radiofrequency current ablationDEVICE

The irrigated radiofrequency current ablation is used for pulmonary vein isolation

irrigated radiofrequency current ablation

Eligibility Criteria

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

You may qualify if:

  • to 80 years
  • persistent atrial fibrillation
  • failure of at least one antiarrhythmic drug
  • others

You may not qualify if:

  • contraindications for pulmonary vein isolation (PVI)
  • previous PVI attempts
  • inability to be treated with oral anticoagulation
  • presence of intracardiac thrombi
  • pregnancy
  • others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Na Homolce Hospital

Prague, 15030, Czechia

Location

Herz- und Gefäß-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Rheinische Friedrich-Wilhelms-Universität Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, 60431, Germany

Location

Städtisches Klinikum Karlsruhe, Medizinische Klinik IV

Karlsruhe, 76133, Germany

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Related Publications (1)

  • Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, Bordignon S, Petru J, Merkel M, Sediva L, Klostermann A, Perrotta L, Cano O, Chun KRJ. Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005767. doi: 10.1161/CIRCEP.117.005767.

    PMID: 29217521DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Boris Schmidt, Dr.

    Cardioangiologisches Centrum Bethanien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Arzt für Kardiologie

Study Record Dates

First Submitted

May 19, 2013

First Posted

May 29, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

CZ(1)ES(1)DE(4)