EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

NCT ID: NCT06212791

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-26

Study Completion Date

2028-03-31

Brief Summary

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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).

Detailed Description

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EXCLAMATORY is a longitudinal observational cohort clinical research study to evaluate the effects of catheter ablation for paroxysmal atrial fibrillation on left atrial and left ventricular performance during exercise, as well as effects on overall exercise capacity

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients under going catheter ablation

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

Self- Report Evaluation-Duke Activity Status Index

Intervention Type BEHAVIORAL

Complete the Self- Report Evaluation-Duke Activity Status Index

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

Intervention Type BEHAVIORAL

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

Cardiopulmonary exercise test (CPET)

Intervention Type DIAGNOSTIC_TEST

Cardiopulmonary exercise test (CPET)

Transthoracic echocardiogram

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiogram at rest and immediately following peak exercise during CPET

Ambulatory cardiac rhythm assessment

Intervention Type DIAGNOSTIC_TEST

Ambulatory cardiac rhythm assessment

Cardiovascular magnetic resonance (CMR)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Self- Report Evaluation-Duke Activity Status Index

Complete the Self- Report Evaluation-Duke Activity Status Index

Intervention Type BEHAVIORAL

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

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

Intervention Type BEHAVIORAL

Cardiopulmonary exercise test (CPET)

Cardiopulmonary exercise test (CPET)

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiogram

Transthoracic echocardiogram at rest and immediately following peak exercise during CPET

Intervention Type DIAGNOSTIC_TEST

Ambulatory cardiac rhythm assessment

Ambulatory cardiac rhythm assessment

Intervention Type DIAGNOSTIC_TEST

Cardiovascular magnetic resonance (CMR)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cory Trankle

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pamela Grizzard

Role: CONTACT

804-628-6234

Melissa Sears

Role: CONTACT

804-828-1601

Facility Contacts

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Pamela Grizzard

Role: primary

804-628-6234

Melissa Sears

Role: backup

804-828-1601

Other Identifiers

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K23HL166956

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20027087

Identifier Type: -

Identifier Source: org_study_id

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