NCT02234102

Brief Summary

The study aims to compare the results of pulmonary vein isolation (PVI) with a single technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with patients who have persistent AF of less than 3 months. Many studies have shown that electrical reconnection of the pulmonary veins following the index procedure can occur in up to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and effective and has also shown promising rates of durable isolation compared to point by point radio frequency techniques. However, the impact of employing this technique for patients with persistent AF has not yet been reported. The study hypothesis is that there will be no statistically significant difference between the results of PVI in the two groups of patients.

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
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

September 4, 2014

Last Update Submit

August 20, 2015

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds

    Between day 90 and 365 after index procedure

Secondary Outcomes (1)

  • Number of electrical cardioversions needed

    365 days after index procedure

Study Arms (2)

Paroxysmal Atrial Fibrillation (PAF)

ACTIVE COMPARATOR

Endoscopically guided laser ablation

Device: Endoscopically guided laser ablation HeartLight system

Persistent Atrial Fibrillation

ACTIVE COMPARATOR

Endoscopically guided laser ablation

Device: Endoscopically guided laser ablation HeartLight system

Interventions

Endoscopically guided laser ablation HeartLight systemDEVICE
Also known as: HeartLight system
Paroxysmal Atrial Fibrillation (PAF)Persistent Atrial Fibrillation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • failure of at least one specific class I or III antiarrhythmic drug (AAD)
  • left atrial size \< 50 mm
  • left ventricular ejection fraction \> 45%
  • others
  • specific for PAF: diagnosed with self-terminating episodes for no longer than 7 days
  • specific for persistent AF: diagnosed with episodes of \> 7 days and \< 90 days

You may not qualify if:

  • AF secondary to a reversible cause of non-cardiac origin
  • uncontrollable hypertension
  • left atrial thrombus
  • others
  • specific for PAF: more than 1 electrical cardioversion in the year prior to enrollment
  • specific for persistent AF more than 4 electrical cardioversions in the year prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St.Vinzenz-Hospital GmbH

Cologne, North Rhine-Westphalia, 50733, Germany

RECRUITING

Märkische Kliniken GmbH, Klinik für Innere Medizin III

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

RECRUITING

Vivantes Netzwerk für Gesundheit GmbH

Berlin, State of Berlin, 13407, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bernd Lemke, Prof. Dr.

    Klinikum Lüdenscheid Klinik f. Innere Medizin III

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernd Lemke, Prof. Dr.

CONTACT

+49 2351 4665551Bernd.Lemke@klinikum-luedenscheid.de

Markus Zarse, PD Dr.

CONTACT

+49 2351 4666299Markus.Zarse@klinikum-luedenscheid.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Klinikdirektor der Klinik für Innere Medizin III

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 9, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

DE(3)