MODULA Modul 7 VRR

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-28

Study Completion Date

2008-05-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial fibrillation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 Ms

NCT00180401

Heart Failure

TERMINATED

MODULA Modul 5 BEAT-HF

NCT00273091

Heart Failure

COMPLETED

Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study

NCT00246805

Permanent Atrial Fibrillation

COMPLETED PHASE4

Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

NCT00267098

Atrioventricular Block Heart Diseases

COMPLETED NA

VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"

NCT00180427

Ventricular Fibrillation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To investigate whether VRR can increase the amount of biventricular pacing in CRT patients with conducted atrial arrhythmias. Secondarily, an investigation will be carried out to determine whether this increase in biventricular pacing results in an improvement in quality of life, as well as an improvement in the symptoms caused by the atrial arrhythmia and an improvement in the level of physical ability.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ventricular Rate Regulation feature ON

Group Type EXPERIMENTAL

CRT devices with ventricular rate regulation [VRR] (CE labeled)

Intervention Type DEVICE

Ventricular Rate Regulation feature OFF

Group Type ACTIVE_COMPARATOR

CRT devices with ventricular rate regulation [VRR] (CE labeled)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CRT devices with ventricular rate regulation [VRR] (CE labeled)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with CRT system with the VRR algorithm
* Patients with permanent atrial fibrillation
* Occasional conducted atrial fibrillation resulting in ventricular rates \> 70 beats per minute (bpm)
* QRS complex \> 120 ms