NCT06212791

Brief Summary

Longitudinal, observational cohort study to evaluate changes in left atrial (LA) reservoir function during exercise and overall exertional capacity in patients following catheter ablation for paroxysmal atrial fibrillation (AF).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Dec 2024

Typical duration for all trials

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 Progress43%
Dec 2024Mar 2028

First Submitted

Initial submission to the registry

December 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

December 26, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

December 19, 2023

Last Update Submit

March 11, 2026

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Catheter ablationExercise capacity

Outcome Measures

Primary Outcomes (1)

  • Change in LA reservoir function reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.

    Change in LA reservoir volume reserve from baseline to follow up, change in left ventricular (LV) stroke volume reserve from baseline to follow up, correlation between changes in LA reservoir volume reserve and changes in LV stroke volume reserve. Therefore the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

    Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

Secondary Outcomes (6)

  • Change in LV stroke volume reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.

    Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

  • Correlation between changes in LA reservoir volume reserve and changes in LV stroke vol reserve after catheter ablation in patients with paroxysmal AF

    Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

  • Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in mixed venous oxygen tension (pVO2) .

    Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

  • Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2

    Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

  • Correlation between baseline AF burden and LA function, LV Function and pVO2

    Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

  • +1 more secondary outcomes

Study Arms (1)

Patients under going catheter ablation

Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden

Behavioral: Self- Report Evaluation-Duke Activity Status IndexBehavioral: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life QuestionnaireDiagnostic Test: Cardiopulmonary exercise test (CPET)Diagnostic Test: Transthoracic echocardiogramDiagnostic Test: Ambulatory cardiac rhythm assessmentDiagnostic Test: Cardiovascular magnetic resonance (CMR)

Interventions

Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life QuestionnaireBEHAVIORAL

Complete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire

Patients under going catheter ablation
Transthoracic echocardiogramDIAGNOSTIC_TEST

Transthoracic echocardiogram at rest and immediately following peak exercise during CPET

Patients under going catheter ablation
Ambulatory cardiac rhythm assessmentDIAGNOSTIC_TEST

Ambulatory cardiac rhythm assessment

Patients under going catheter ablation
Cardiovascular magnetic resonance (CMR)DIAGNOSTIC_TEST

Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)

Patients under going catheter ablation
Self- Report Evaluation-Duke Activity Status IndexBEHAVIORAL

Complete the Self- Report Evaluation-Duke Activity Status Index

Patients under going catheter ablation
Cardiopulmonary exercise test (CPET)DIAGNOSTIC_TEST

Cardiopulmonary exercise test (CPET)

Patients under going catheter ablation

Eligibility Criteria

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

In patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden will result in favorable LA reverse remodeling - which will result in improved LA reservoir function reserve during exercise, thereby augmenting LV stroke volume reserve during exercise.

You may qualify if:

  • Age ≥18 years
  • Diagnosis of paroxysmal AF
  • Left ventricular ejection fraction ≥50%
  • Scheduled for catheter ablation
  • Able to speak, hear, and read English
  • Willing and able to provide informed consent

You may not qualify if:

  • Persistent or permanent AF
  • Prior ablation (catheter based or surgical) for AF
  • Significant sinus node dysfunction
  • Implanted pacemaker or defibrillator
  • Contraindication to or inability to complete cardiovascular magnetic resonance study
  • Contraindication to or inability to complete exercise testing
  • Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73m2
  • Severe left ventricular hypertrophy
  • Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to:
  • Hypertrophic cardiomyopathy
  • Cardiac amyloidosis
  • Constrictive pericarditis
  • Pulmonary arterial hypertension
  • Prior cardiac surgery
  • Active pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Exercise TestEchocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesCardiac Imaging TechniquesDiagnostic ImagingUltrasonography

Study Officials

  • Cory Trankle

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Grizzard

CONTACT

804-628-6234pamela.grizzard@vcuhealth.org

Melissa Sears

CONTACT

804-828-1601melissa.sears@vcuhealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 19, 2024

Study Start

December 26, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

US(1)