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Optimization of Rate-response Feature of Pacemakers in Patients with Sick Sinus Syndrome: a randomized cross-over controlled trial.

Optimization of Rate-response Feature of Pacemakers in Patients with Sick Sinus Syndrome: a randomized cross-over controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020977
Enrollment
Unknown
Registered
2019-01-23
Start date
2019-01-22
Completion date
Unknown
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

Interventions

Group 1:Phase I: optimal rate-response feature
Phase II: default rate-response feature
Group 2:Phase I:default rate-response feature
Phase II: optimal rate-response feature

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1 Sign the informed consent and indicate the date of signing; 2 Patients who aged 18 to 80 years; 3 Patients with sick sinus node syndrome who have received pacemaker implantation and survived the acute postoperative period (3 months); 4 Patients who have been identified for exercise testing.

Exclusion criteria

Exclusion criteria: 1 Basic heart rate is above 95 BPM; 2 Persistent or permanent atrial fibrillation patients; 3 NYHA Level IV; 4 Heart sports rehabilitation contraindications, including but not limited to, unstable angina, decompensated heart failure, the activity of pericarditis or myocarditis, hypertrophic cardiomyopathy, valvular disease, resting ECG ST segment displacement is greater than 2 mm, etc.; 5 Acute heart failure within three months; Angina pectoris occurred within half a year, ST dynamic change occurred within three months or heart attack after 45 days; 6 QRSd > 130 ms; 7 Severe liver and kidney dysfunction; 8 Hypertension while blood pressure is uncontrolled; 9 Pregnant or women who decide to pregnant during research stage; 10 Patients who have already enrolled in other clinical studies which may affect the purpose of this study.

Design outcomes

Primary

MeasureTime frame
Aquarel + SF-36;

Secondary

MeasureTime frame
NYHA;six-minutes walking test;Treadmill exercise testing;

Countries

China

Contacts

Public ContactLi Ruogu
pengyimin1973@163.com+86 18017320201

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026