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BIVPACE-AVB

BIVentricular PACing for prEvention of HF in Patients with High Degree of AV Block

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000832
Enrollment
Unknown
Registered
2010-03-20
Start date
2009-05-11
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

AV block, Heart Failure

Interventions

two:The eligible patients undergo the CRT (Insync III 8024 or newer, Medtronic Inc.) procedure, and randomize into biventricular pacing (group A) and right verntricular apical pacing (Group B) after o

Sponsors

First Affiliated Hospital of Nanjing Medical University & Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Third degree AV block; 2. Second degree AV-block; 3. Indication for replacement of pacemaker and the ventricular pacing rate more than 40%; 4. LVEF > 35%; 5. NYHA class I-III in previou 90 days; 6. Writtern informed consent from patients or their guardians; 7. Life expectancy >12 months.

Exclusion criteria

Exclusion criteria: 1. Indication for CRT (LVEF <=35%); 2. ACS, PCI and CABG procedures in previou 30 days; 3. Acute myocarditis in last 3 months; 4. Replacement and repair of cardiac valves in previou 6 months; 5. Indications for Replacement and repair of cardiac valves; 6. Implanted prosthetic tricuspid valve; 7. Ongoing or planned pregnancy in the next 6 months; 8. Participation in other clinical trial; 9. Cardiac transplantation; 10. NYHA class IV in previous 90 days.

Design outcomes

Primary

MeasureTime frame
The left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV);

Secondary

MeasureTime frame
left ventricular end-diastolic volume, LV end-diastolic and endsystolic diameters, Left atrial diment, NYHA class, 6-minute walk distance, the Minnesota Heart Failure Quality of life scoring, N-terminal pro-B-type natriuretic peptide original (NT proBNP) and atrial high-frequency event;

Countries

China

Contacts

Public ContactQijun Shan
qjshan@njmu.edu.cn+86 025 68136407

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026