Quality of Life in Patients With Postoperative Atrial Fib... | NCT07173998

Studies
Quality of Life in Patients With Postoperative Atrial Fibrillation After Cardiac Surgery

NCT07173998

Sponsor

Brigham and Women's Hospital

Status

Recruiting

Last Update Posted

Jun 29, 2026Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

Postoperative Atrial Fibrillation

Interventions

Survey

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jul 1, 2027Estimated

First Submitted Date

Sep 8, 2025

First Submission Date that Met QC Criteria

Sep 8, 2025

First Posted Date

Sep 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2026

Last Update Posted Date

Jun 29, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jakob Wollborn, MD, Principal Investigator, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is a prospective observational study on quality of life in patients after cardiac surgery with postoperative atrial fibrillation. Patients will answer surveys before their surgery as well as one and three months after their heart operation. The survey includes SF-36, TSQM-9 and qualitative questions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Target group		Adult patients undergoing cardiac surgery with cardiopulmonary bypass	Other: Survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	SF-36, TSQM-9, qualitative questions	Target group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SF-36 scores	compare development and absolut SF-36 scores	before, one month and three months postop

Secondary Outcomes

Measure	Description	Time Frame
Qualitative questions	exploratory evaluation of qualitative questions	before, one month and three months postop
TSQM-9 scores	TSQM-9 scores in Afib-patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing cardiac surgery with cardiopulmonary bypass

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leonard Simeth, cand.med.	Contact	+1 6173 529209		lsimeth@bwh.harvard.edu

Overall Officials

Name	Affiliation	Role
Jakob Wollborn, MD, MPH	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mass General Brigham	Recruiting	Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided