NCT07173998

Brief Summary

Prospective observational study on quality of life with postoperative atrial fibrillation after cardiac surgery using SF-36 and qualitative questions

Trial Health

77
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress54%
Jul 2025Jul 2027

Study Start

First participant enrolled

July 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

September 8, 2025

Last Update Submit

June 26, 2026

Conditions

Postoperative Atrial Fibrillation

Keywords

cardiac surgeryrecovery

Outcome Measures

Primary Outcomes (1)

  • SF-36 scores

    compare development and absolut SF-36 scores

    before, one month and three months postop

Secondary Outcomes (2)

  • Qualitative questions

    before, one month and three months postop

  • TSQM-9 scores

    one month and three months postop

Study Arms (1)

Target group

Adult patients undergoing cardiac surgery with cardiopulmonary bypass

Other: Survey

Interventions

SurveyOTHER

SF-36, TSQM-9, qualitative questions

Target group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing cardiac surgery with cardiopulmonary bypass

You may qualify if:

  • All genders
  • Ages 18-99 years old
  • Scheduled to undergo cardiac surgery
  • Able to answer survey questions

You may not qualify if:

  • Persistent / permanent atrial fibrillation
  • Atrial fibrillation at presentation for surgery
  • Emergent operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jakob Wollborn, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonard Simeth, cand.med.

CONTACT

+1 6173 529209lsimeth@bwh.harvard.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)