NCT02064114

Brief Summary

Study hypothesis: Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an obesity treatment after atrial fibrillation ablation. Study design: A prospective randomized, open-label clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

6 years

First QC Date

February 13, 2014

Last Update Submit

September 16, 2022

Conditions

Atrial FibrillationObesitySleep Apnea

Keywords

BMI >40

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation

    AF burden is defined as overall percentage of AF during the observed period.

    12 months

Secondary Outcomes (9)

  • AF burden between 0 and 12 months after first AF ablation

    12 months

  • AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation

    12 months

  • Freedom of AF (after 3 months blanking period)

    12 months

  • Time to first recurrent AF (after 3 months blanking period)

    12 months

  • Body Mass Index (BMI) change from BL to 12 months

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.

Procedure: Intervention group

control group

ACTIVE COMPARATOR

conventional treatment, followed for a period of 3,6 and 12 months after the procedure.

Procedure: control group

Interventions

Intervention groupPROCEDURE

Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.

Intervention group
control groupPROCEDURE

Followed for a period of 3,6 and 12 months after the procedure.

control group

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Overweight with a BMI ≥ 30
  • Obtained written informed consent
  • Symptomatic atrial fibrillation with indication for ablation

You may not qualify if:

  • Age \<18 years
  • Permanent atrial fibrillation (failed Cardioversion or episode duration \> 12 months)
  • Previous surgical or interventional therapy of atrial fibrillation
  • BMI \> 40
  • Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
  • History of hemorrhagic diathesis or other coagulopathies
  • Contraindications for oral anticoagulation
  • Hyper- or hypothyroidism
  • Drug or chronic alcohol abuse
  • Has any condition that would make participation not be in the best interest of the subject
  • Incompliance
  • Unable to perform athletic exercise due to disease or disability
  • Resident outside Hamburg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universitäres Herzzentrum Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Herzzentrum der Universität zu Köln

Cologne, Germany

Location

Asklepios ST. Georg

Hamburg, 20246, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • Gessler N, Willems S, Steven D, Aberle J, Akbulak RO, Gosau N, Hoffmann BA, Meyer C, Sultan A, Tilz R, Vogler J, Wohlmuth P, Scholz S, Gunawardene MA, Eickholt C, Luker J. Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial. Europace. 2021 Oct 9;23(10):1548-1558. doi: 10.1093/europace/euab122.

    PMID: 33895833DERIVED

MeSH Terms

Conditions

Atrial FibrillationObesitySleep Apnea Syndromes

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Christian Meyer

    University Heart Center Hamburg

    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

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 17, 2014

Study Start

January 1, 2014

Primary Completion

January 16, 2020

Study Completion

January 16, 2020

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)