NCT07270757

Brief Summary

The primary objective of this study is to compare the effects of a preoperative prehabilitation program versus usual care on post-procedural cardiorespiratory function and clinical outcomes in patients undergoing catheter ablation for atrial fibrillation.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 8, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

Atrial FibrillationCardiac rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Peak Oxygen Uptake at 3 months

    Measure: Cardiopulmonary exercise testing

    3 months post-ablation

  • Atrial Arrhythmic Events within 90 days

    Any atrial arrhythmic events happened within 90 days after the procedure

    Within 90 days post-ablation

Study Arms (2)

Prehabilitation Group

EXPERIMENTAL

Structured Prehabilitation Program for 4 weeks before ablation

Other: 4-week structured prehabilitation program (exercise training + psychological education)

Usual Care Group

NO INTERVENTION

Standard Preoperative Care

Interventions

The prehabilitation group will receive a 4-week structured program before ablation, including: Individualized exercise training: Prescription based on cardiopulmonary exercise test results, including aerobic exercise (40%-60% of heart rate reserve) and resistance training Psychological and educational intervention: Structured education based on cognitive behavioral therapy principles, focusing on addressing kinesiophobia Delivery mode: Hybrid (supervised in-hospital sessions + monitored home-based sessions) The usual care group will receive only standard preoperative education without structured rehabilitation.

Prehabilitation Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-70 years
  • Scheduled for first AF ablation
  • NYHA class I-II
  • LVEF ≥ 50%

You may not qualify if:

  • Significant structural heart disease (e.g., severe valvular disease)
  • Contraindications to CPET or exercise training
  • Cognitive impairment preventing cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Please Select, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The First Affiliated Hospital with Nanjing Medical University

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 8, 2025

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations